Pan Arab Liver Transplantation Registry - the Research Centre Page

Pan Arab Liver 

Transplantation Registry 

First Annual Report 

Reported cases from King Faisal Specialist Hospital & Research Center 

Riyadh, Saudi Arabia

Acknowledgement 

The Pan Arab Liver Transplantation Registry committee would like to thank Dr Qasim Al-Qasabi, 

Chief Executive Director and Dr. Sultan Al Sedairy, Executive Director of the Research Centre for 

their continued support in provision of resources. We thank all members who are and have been 

part of this registry. With their support and dedication towards this registry, the registry has 

successfully completed its first phase of patient registration. 

Acknowledgement goes to: 

• Prof. Mohamed Al Sebayel 

• Dr. Hatem Khalaf 

• Ms. Shazia Naz Subhani 

• Dr. Mohammad Shoukri 

• Mr. Mahmoud Saleh 

• Ms. Carla Mercado 

We also like to thank the Pan Arab Liver Transplantation Society especially Professor Ibrahim 

Mustafa, PALT Secretary and Professor Ibrahim Marawan, PALTS President for their continuous 

support for this registry. 

We also wish to thank all the staff of the liver transplant team especially Mr. Mahmoud Saleh, 

Senior Liver transplant clinical coordinator who has bestowed tremendous efforts in updating and 

uploading patient information into the web-based registry. 

Great appreciation goes to the Department of Biostatistics, Epidemiology and Scientific Computing, 

that maintained a true collaborative spirit to make this registry a success. Special thanks to 

Registries Core Facility and Biostatistics Research Group, BESC for their continued technical 

support and assistance. 

Finally, we would like to thank all liver transplant centers who expressed their willingness to join the 

registry especially Riyadh Military Hospital in Saudi Arabia headed by Dr. Atef Al-Bassas and Wady 

El-Nile Hospital in Egypt headed by Professor Mahmoud El-Meteini.

Founders of the Registry 

Professor Mohamed al-Sebayel 

Dr. Hatem Khalaf 

Primary Investigators 

Professor Mohamed al-Sebayel 


Software/Report Design 

Ms. Shazia Naz Subhani 

Registry Committee 

Professor Mohamed al-Sebayel, MD 

Chairman, Department of LTx and 

Hepatobiliary-Pancreatic Surgery 

Dr. Hatem Khalaf, MD 

Associate Consultant, Department of LTx 

and Hepatobiliary-Pancreatic Surgery 

Dr. Mohammad Shoukri, PhD 

Head Bio Statistics Group, Acting Head, BESC Department 

Ms. Shazia Naz Subhani, MSc 

Head-Registries Core Facility, 

BESC Department 

Mr. Saleh Mahmoud, B.S.N 

Coordinator, Department of LTx 

and Hepatobiliary-Pancreatic Surgery 

Copies can be obtained from: Dr. Hatem Khalaf 

Email: hatem@khalaf.us 

Telephone: 00966-1-4424818 

Fax: 00966-1-4424817 

Mailing Address: KFSH&RC, BESC, MBC 72, P.O. Box 3354, Riyadh 11211, Saudi Arabia 

E-copy can be downloaded from http://rc.kfshrc.edu.sa/rcf

Message from Registry Chairman 

One of the main goals of the Pan Arab Liver Transplant Society (PALTS) has been the creation 

and establishment of a Pan Arab Liver Transplantation Registry. This goal has been achieved and 

now we have two center enrolling more than 500 patients in the registry. We are hoping that soon 

others will join. PALTS registry is an investment for the future and its value will definitely be 

appreciated by all of those who are involved in liver transplant ion in the Arab World. 

In order for it to be successful and fruitful we need to be all committed to the idea and work 

persistently and constantly towards its execution. The King Faisal Specialist Hop ital and Research 

Center in Riyadh Saudi Arabia provided all the necessary technical support to this project. It 

remains for the program directors to make use of such generous technical support. I urge all the 

liver transplant programs to take advantage of this opportunity and work hard on getting their 

patients registered and continuously update their data. These data are meant to help individual 

programs and hopefully be able collectively to make use of this registry to advance liver 

transplantation in the Arab World under the Umbrella of the Pan Arab Liver Transplant Society 

(PALTS). 

The team at King Faisal Specialist Hospital is proud to present the first annual report on the 

collected and entered data from KFSH&RC. A lot of hard work and efforts has been in place for this 

report. I would like to express my deepest gratitude to those who worked behind the scenes in 

order to bring this report to light. 

Professor Mohamed Al-Sebayel 

Chairman, Department of LTx and Hepatobiliary-Pancreatic Surgery 

President of the Pan Arab Liver Transplantation Society 

King Faisal Specialist Hospital & Research Centre, Riyadh

Message from Principal Investigator of the Registry 

Liver transplantation is the only hope of cure for those patients who are suffering from end-stage 

liver disease. In the Arab world, there are above 15 liver transplant centers that have performed 

over 1000 liver transplants over the past 15 years. In view of such a large liver transplant activity in 

the Arab world, the initiation of a Pan Arab Liver Transplantation Registry seemed a rational idea 

aiming to monitor and coordinate those activities in the Arab world. Our vision is that the registry 

will help in creating a scientific forum for discussion of all issues related to liver transplantation in 

the Arab World including medical, ethical, social and legal aspects. 

The registry was initially suggested during the proceedings of the 1st meeting of the Pan Arab Liver 

Transplantation (PALTS) that was held in Cairo, March 2006. Thereafter, registry bylaws were 

approved by PALTS Council in 2nd Pan Arab Liver Transplantation Congress that was held in 

Riyadh, March 2007. The group agreed that the registry shall be hosted by the Registries Core 

Facility (RCF), Department of Biostatistics, Epidemiology and Scientific Computing (BESC), King 

Faisal Specialist Hospital and Research Center. The registry proposal was then submitted and 

approved by Office of Research Affairs (ORA) on 2 nd April 2007 with the understanding that it will 

progress over the following three phases: 

• Phase I: Liver Transplant patients in KFSH&RC 

• Phase II: Liver Transplant Centers in Saudi Arabia 

• Phase III: Liver Transplant Centers in Arab World 

Since its approval, and over a short period of time, we were able to successfully complete phase I 

which will be fully documented in this First Annual report. We have also approached all liver 

transplant centers in Saudi Arabia and the Arab world, and currently there are two other liver 

transplant centers actively participating to this growing registry. 

In the future, we are hoping to complete remaining phases of the registry through encouraging all 

liver transplant programs in the Arab World to join the registry. 

Finally, it is worth emphasizing that our success has only been possible through the unlimited help 

and support from ORA and BESC Department, and that their continued support will enable us to 

achieve our future goals. 


Associate Consultant 

Department of LTx and Hepatobiliary-Pancreatic Surgery 

King Faisal Specialist Hospital & Research Centre, Riyadh

Message from Chairman, Department of BESC 

The BESC Department has been demonstrating its commitment to provide state-of-the-art 

technology to achieve the fundamental objectives of the Pan Arab Liver Transplantation Registry. 

We continue to find opportunities to collaborate with more hospital and health care centers to 

increase the number of registered cases. 

The amount of work put forward to produce this report manifests the commitments of our clinicians 

to provide better care to people of the Kingdom of Saudi Arabia. 

As the BESC Department undertook this and other registries, the style and scope of their annual 

reports change substantially, demonstrating the solid commitment of the BESC staff to advance our 

strategic objectives as documented in our annual report of the KFSHRC. The BESC people remain 

proud of the progress made thus far and we look forward to the future and build on our 

achievements. 

On behalf of the Department staff I would like to thank Dr Sultan Sedairy the Executive Director of 

the Research Centre and Dr. Futwan Al-Mohanna, the Deputy Executive Director for their 

continued support to this and other projects. 

Mohamed Shoukri, PhD 

Principal Scientist & Chairman 

Department of Biostatistics, Epidemiology and Scientific Computing 

King Faisal Specialist Hospital and Research Center

Table of Contents 

Topics Page # 

LIST OF TABLES & FIGURES .......................................................................................................2 

EXECUTIVE SUMMARY .................................................................................................................3 

LIVER DISEASE BACKGROUND ..................................................................................................5 

Why is the liver important? ..........................................................................................................5 

INTRODUCTION..............................................................................................................................6 

Objectives ....................................................................................................................................6 

Software Design ..........................................................................................................................6 

Data Validation Checks ............................................................................................................7 

Privacy and Confidentiality Issues...............................................................................................7 

SECTION 1: DEMOGRAPHIC DATA .............................................................................................8 

SECTION 2: INDICATION FOR TRANSPLANT (ORIGINAL DISEASE).......................................9 

Indications for Transplantation ..................................................................................................10 

Types of Liver Transplantation ..................................................................................................13 

Pre-operative Details .................................................................................................................15 

SECTION 3: COMPLICATIONS....................................................................................................17 

SECTION 4: SURVIVAL ANALYSIS ............................................................................................19 

Patient Survival.......................................................................................................................19 

Graft Survival..........................................................................................................................19 

REFERENCES...............................................................................................................................24 

APPENDICES

First PanArab Liver Transplantation Report – King Faisal Specialist Hospital & Research Center 

LIST OF TABLES & FIGURES 

Table 1.1: Transplantation Locations Distribution by Gender..........................................................8 

Table 1.2: Distribution of Patients Age at Transplant .....................................................................8 

Figure 1.1: Pediatrics vs. Adults Distribution ...................................................................................9 

Table 1.3: Distribution of Patients Status.........................................................................................9 

Table 1.4: Distribution of Patients Blood Group...............................................................................9 

Table 2.1: Distribution of Indications (Original Disease) for Transplantation.................................10 

Figure 2.1 (a): Distribution of Selected Indication (4 Categories) for Transplantation...................10 

Figure 2.1 (b): Distribution of Selected Original Diseases (4 Categories) for Transplantation......11 

Figure 2.2 (a): Distribution of Selected Indication (6 Categories) for Transplantation...................11 

Figure 2.2 (b): Distribution of Selected Original Diseases (6 Categories) for Transplantation......12 

Table 2.3: Distribution of Type of Listing for Transplantation ........................................................13 

Table 2.4: Distribution for Type of Transplantation........................................................................13 

Table 2.5: Distribution of Graft Types used for LDLT Transplantation ..........................................14 

Table 2.6: Distribution of HCC LTx based on Milan’s Criteria .......................................................14 

Table 2.7: Distribution of Combined Liver & Kidney Transplantation ............................................14 

Table 2.8: Distribution of Blood Units for Transplantation .............................................................15 

Table 2.9: Distribution of Biliary Anastomosis ...............................................................................16 

Table 2.10: Distribution of Primary Immunosuppressions for Transplantation..............................16 

Table 3.1: Distribution of Various Complications after Transplantation.........................................17 

Table 3.2: Distribution of Graft Failure after Transplantation.........................................................18 

Table 3.3: Distribution of Patient’s Mortality after Transplantation ................................................18 

Figure 4.1: Overall Patient Survival in KFSH&RC .........................................................................19 

Figure 4.2: Overall Patient Survival in non-KFSH&RC ..................................................................20 

Figure 4.3: Patient Survival for HCV versus non-HCV in KFSH&RC ............................................20 

Figure 4.4: Patient Survival for HCV versus non-HCV in non-KFSH&RC .....................................21 

Figure 4.5: Patient Survival for HCC versus non-HCC in KFSH&RC............................................21 

Figure 4.6: Patient Survival for HCC versus non-HCC in non-KFSH&RC.....................................22 

Figure 4.7: Patient Survival for DDLT versus LDLT in KFSH&RC ................................................22 

Figure 4.8: Overall Graft Survival in KFSH&RC ............................................................................23 

Figure 4.9: Graft Survival for DDLT versus LDLT in KFSH&RC....................................................23 

2


EXECUTIVE SUMMARY 

In March 2006, the 1st Pan Arab Liver Transplantation Congress was held in Cairo with great 

success. The meeting witnessed the birth of the Pan Arab Liver Transplantation Society (PALTS). 

One of the main goals of the Pan Arab Liver Transplantation Society was establishing a Web- 

Based Pan Arab Liver Transplantation Registry that will help in promoting and encouraging 

education, research and cooperation in the field of liver transplantation between various liver 

transplant programs in the Arab World. 

Keeping in view this goal, in the year 2005 the first of its kind Pan Arab Liver Transplantation 

web-based registry was designed and developed and became prospective for the King Faisal 

Specialist Hospital as a part of Phase I of the registry objectives. This registry is a collaborative 

work between the Department of LTx and Hepatobiliary-Pancreatic Surgery and, the Department 

of Biostatistics, Epidemiology and Scientific Computing (BESC). 

This is a first report with a total of 408 cases that have been included in the registry database 

between years 2005 - 2008. In this report, descriptive statistics on various data items pertaining 

to the demographics and complications have been tabulated in detail. 

All tables are tabulated with respect to the data reported from “In center” i.e. from KFSH&RC and “Out 

center” meaning patients who underwent transplantation surgeries in centers other than KFSH&RC but are 

followed-up for treatment in KFSH&RC. 

A total of (102; 38.3%) male patients are operated in KFSH&RC and (164; 61.7%) from abroad. 

Similarly, a total of (65; 45.8%) female patients from KFSH&RC and (77; 44.2%) from abroad are 

registered in the database. A pre-dominance of male members can clearly be seen for 

transplanted cases between the years 31 and 60 with a count of (100; 59.9%) from KFSH&R and 

an overall count of (219; 53.7%) patients from both locations. The under went transplantation 

pediatric population is recorded as 7.8 percent for KFSH&RC with an overall percentage of 12.7. 

Viral hepatitis (i.e. HCV, HBV, or both) with of without hepatocellular carcinoma (HCC) remains 

the main indication for liver transplantation in both KFSP&RC patient and those transplanted 

abroad. 

In both groups, Deceased Donor Liver Transplantation (DDLT) was the main type of 

transplantation compared to Living (LDLT). The severe shortage of cadaveric organs remains the 

main obstacle facing LT in Saudi Arabia and all over the world. In Saudi Arabia, this shortage is 

due to many complex logistical problems in all steps of the cadaveric donation process, including 

donor identification, reporting, diagnosis, management, documentation, and obtaining consent 

(ref 1). This distressing scarcity of cadaveric organs, together with the increasing number of 

patients dying on our LT waiting list has significantly limited our ability to expand LT program at 

KFSH&RC. Therefore, we were forced to consider adopting LDLT, which seemed the only logical 

way forward in our situation. Our initial reluctance to undertake LDLT was fueled by the many 

3


ethical questions that are generated by the concept of live liver donation. In our early experience 

with LDLT at KFSHRC, we were astonished by how difficult it is to find living donors who fulfill our 

criteria for liver donation. Many candidates have been rejected for a variety of reasons, including 

unexpected pathology (steatosis and viral disease) and failure to pass psychosocial evaluation 

Ref (2). Therefore, we came to the conclusion that LDLT is not the answer to all of our 

challenges, and that this procedure can help alleviate the problem of organ shortage, but cannot 

replace DDLT in Saudi Arabia. We believe that we should focus our efforts on identifying and 

fixing the different problems that have led to the decline in the number of available cadaveric 

donors. By doing so, we hope to considerably increase the cadaveric organ pool for LT in Saudi 

Arabia. 

Survival analysis is demonstrated by different survival curves, however, it is worth emphasizing 

that we cannot compare the survival of KFSH&RC patients with those transplanted abroad due to 

the incomplete peri-operative mortality data on patients transplanted abroad (3). In this registry 

we can only report survival data on those patients who are followed-up at KFSH&RC after being 

transplanted abroad, however, there is a considerable number of patients transplanted abroad 

and for whom we do not have complete survival data. 

4


LIVER DISEASE BACKGROUND 

The liver is a pinkish-brown "boomerang shaped" organ in the 

human body. It is the second largest organ and the largest gland. 

The liver plays a major role in metabolism and has a number of 

functions in the body including glycogen storage, plasma protein 

synthesis, and drug detoxification. 

The liver is among the few internal human organs capable of 

natural regeneration of lost tissue; as little as 25 percent of 

remaining liver can regenerate into a whole liver again. 

Why is the liver important? 

The liver is important because it stores and mobilizes energy in your body by controlling blood 

sugar, regulating fat storage and aiding digestion by producing bile. It also regulates blood 

clotting by manufacturing blood proteins and filters blood to eliminate bacteria and poisons in the 

system. The liver breaks down drugs, stores minerals and produces vitamins such as Vitamin D 

and Iron. 

There are several types of liver disease. 

• Hepatitis - inflammation of the liver, caused mainly by various viruses but also by 

some poisons, autoimmunity or hereditary conditions. 

• Cirrhosis - the formation of fibrous tissue in the liver, replacing dead liver cells. The 

death of the liver cells can for example be caused by viral hepatitis, alcoholism or 

contact with other liver-toxic chemicals. 

• Hemochromatosis - a hereditary disease causing the accumulation of iron in the 

body, eventually leading to liver damage. 

• Cancer of the liver - primary hepatocellular carcinoma or cholangiocarcinoma and 

metastasis cancers, usually from other parts of the gastrointestinal tract. 

• Wilson's disease - a hereditary disease which causes the body to retain copper. 

• Primary sclerosing cholangitis - an inflammatory disease of the bile duct, 

autoimmune in nature. 

• Primary biliary cirrhosis - autoimmune disease of small bile ducts. 

• Budd-Chiari syndrome - obstruction of the hepatic vein. 

• Gilbert's syndrome - a genetic disorder of bilirubin metabolism, found in about five 

percent of the population. 

• Glycogen storage disease type II - The build-up of glycogen causes progressive 

muscle weakness (myopathy) throughout the body and affects various body tissues, 

particularly in the heart, skeletal muscles, liver and nervous system. 

5


INTRODUCTION 

The liver transplantation programs in Saudi Arabia started slowly in early 1990’s with a lot of 

visibility and propaganda, however, these programs have been dealing with only a very limited 

number of patients, not exceeding 50 patients per year at the maximum. The government has 

been also sending patients abroad for liver transplantation but that number does not exceed 50 

and at best a total of only 100 patients are transplanted inside and outside the kingdom. The 

sever organ shortage in Saudi Arabia forced liver transplant programs to consider living donor 

liver transplantation that was started at KFSH&RC in 2002 with good outcomes. Since the early 

90s Liver Transplantation became a reality in the Arab World with Saudi Arabia leading the way 

for a decade followed by Egypt in the era of Living Donor Liver Transplantation and more recently 

Jordan and Lebanon. 

In March 2006, the 1st Pan Arab Liver Transplantation Congress was held in Cairo with great 

success. The meeting witnessed the birth of the Pan Arab Liver Transplantation Society (PALTS). 

The 2nd Pan Arab Liver Transplantation Congress, which was held in Riyadh on 14-15 March 

2007, was a continuation of the effort to consolidate the cooperation between members of the 

transplant teams in the Arab countries in order to meet the challenges facing liver transplantation 

in the Arab World. 

Objectives 

• To obtain the frequency of liver transplantation activity in KFSH&RC followed by KSA and 

the Arab countries. 

• To measure the extent and magnitude of the problem of end-stage liver disease 

necessitating Liver Transplantation in KSA and the Arab world. 

• To identify the need of Liver Transplantation in KSA and the Arab World. 

• To Document the treatment procedure and assessment of treatment outcome. 

Software Design 

The software used for data entry, updates, reports, charts and analysis is a web based system 

with SQL 2000 database as a back end and internet-enable design as a front end. The Web 

Server used for the design of the Pan Arab Liver Transplant Registry is the Microsoft Internet 

Information Server (IIS). Forms are designed using Hypertext Markup Language (HTML) with 

Active Server Pages (ASP) and ActiveX Data Objects (ADO). The database structure is 

developed with Platinum Erwin version 3.5.2 for entity relationship modeling. The database 

including all the tables, indexes, rules, stored procedures, views and triggers is created and 

maintained with Microsoft SQL Server 2000. 

6


Only authorized users can access registry software. In addition to several security checks, the 

system is designed as such that there are three major kind of users that can have access to the 

registry software with defined set of privileges: 

These users can be categorized as: 

Admin users with administrative rights like creating new users, data validation, data deletion and 

modifying static table information in addition to full control on data entry and update modules. 

Common users with limited data entry and data modification privileges. 

Browse only users with browsing privileges only, without any data modification, deletion and 

export privileges. 

Data Validation Checks 

All data entry forms have validation checks and warning messages that restrict users from 

making any data entry mistakes while entering the data on the web based registry software. 

Validation rules are designed as a quality check of data entered in the database. 

Privacy and Confidentiality Issues 

Technologies now allow personally identifiable health information to be easily collected, 

correlated and widely transmitted, renewing concerns over privacy and confidentiality. Since the 

registry is collecting personally identifiable health data, one of the major responsibilities of the 

registrar is to ensure attention to privacy as a fundamental consideration in collection and use of 

data and information being maintained. It is also realized by the registry staff that mistakes in 

handling or protecting health data might result in revealing the intimate details of innocent 

people’s lives. The Registries Core Facility ensures that only authorized individuals handle the 

raw data and information managed by the registry database, and that data is accessible to the 

right people through assigned passwords. 

7


SECTION 1: DEMOGRAPHIC DATA 

In this section, descriptive statistics on various data items pertaining to the demographics have 

been tabulated in details. The registry data includes all patients that either underwent Liver 

Transplantation in KFSH&RC or are referral cases for follow up treatment from other Arab countries or 

abroad. 

All tables are tabulated with respect to the data reported from “In center” meaning patients from KFSH&RC 

and “Out center” meaning patients who underwent transplantation surgeries in centers other than KFSH&RC 

but are followed-up for treatment in KFSH&RC. 

Demographic Data comprises of the following distribution tables: 

1. Gender 

2. Age at Transplant 

3. Patient Status 

4. Patient’s Blood Groups 

Table 1.1: Transplantation Locations Distribution by Gender 

Male Female Total 

KFSH&RC (in center) 102 38.3% 65 45.8% 167 40.9% 

KFSH&RC (out center) 164 61.7% 77 54.2% 241 59.1% 

China 42 25.6% 12 15.6% 54 22.4% 

U.S.A 87 53.0% 51 66.2% 138 57.3% 

Germany 21 12.8% 3 3.9% 24 10.0% 

UK 4 2.4% 5 6.5% 9 3.7% 

Old KFSH 10 6.1% 6 7.8% 16 6.6% 

Total 266 142 408 

Table 1.2: Distribution of Patients Age at Transplant 

Transplantation Location 

KFSH&RC Abroad Total 

Between 0 and 14 13 7.8% 39 16.2% 52 12.7% 

Between 15 and 30 40 24.0% 21 8.7% 61 15.0% 

Between 31 and 60 100 59.9% 119 49.4% 219 53.7% 

Age > 60 years 14 8.4% 62 25.7% 76 18.6% 

Total 167 241 408 

Criteria for Pediatric population registered in the Pan Arab Liver Transplantation database is 

patients with age < 14 years. Figure 1.1 gives a quick snapshot of the Adult vs. Pediatrics 

patient’s distribution. 

8


Figure 1.1: Pediatrics vs. Adults Distribution 

87.3% 

12.7% 

Pediatric 

Adult 

Table 1.3: Distribution of Patients Status 

Transplant Location 


Alive 143 85.1% 217 90.0% 360 88.0% 

Dead 24 14.3% 24 10.0% 48 11.7% 

Total 167 241 408 

Table 1.4: Distribution of Patients Blood Group 



Unknown 0 0% 133 55.19% 133 32.60% 

A- 3 1.80% 1 0.41% 4 0.98% 

A+ 49 29.34% 27 11.20% 76 18.63% 

B- 5 2.99% 2 0.83% 7 1.72% 

B+ 38 22.75% 24 9.96% 62 15.20% 

AB+ 9 5.39% 2 0.83% 11 2.70% 

AB- 2 1.20% 0 0.00% 2 0.49% 

O+ 59 35.33% 49 20.33% 108 26.47% 

O- 2 1.20% 3 1.24% 5 1.23% 

Total 167 241 408 

SECTION 2: INDICATION FOR TRANSPLANT (ORIGINAL DISEASE) 

There are several indicators that determine the need for a liver transplantation. All these 

indicators are tabulated in detail in the following tables. 

9


Indications for Transplantation 

A total of (n=168; 41.0%) cases with indication of transplantation are registered from KFSH&RC 

and (n=241; 58.9%) from abroad. Table 2.1 provides counts for all indications for transplantation 

in detail. 

Table 2.1: Distribution of Indications (Original Disease) for Transplantation 



HCV 63 37.7% 90 37.3% 153 37.5% 

HBV 31 18.6% 72 29.9% 103 25.2% 

HCC 29 17.4% 59 24.5% 88 21.6% 

GSD 4 2.4% 3 1.2% 7 1.7% 

Hypercholestremia 0 0.0% 0 0.0% 0 0.0% 

Biliary Atresia 0 0.0% 8 3.3% 8 2.0% 

FHP 1 0.6% 0 0.0% 1 0.2% 

PBC 0 0.0% 1 0.4% 1 0.2% 

SBC 2 1.2% 2 0.8% 4 1.0% 

PSC 3 1.8% 5 2.1% 8 2.0% 

AIH 21 12.6% 8 3.3% 29 7.1% 

Alcoholic Liver Disease 0 0.0% 1 0.4% 1 0.2% 

Wilson's 11 6.6% 8 3.3% 19 4.7% 

Hemochromatosis 0 0.0% 5 2.1% 5 1.2% 

Alpha-1-Antitrypsin Def 0 0.0% 0 0.0% 0 0.0% 

Hyperoxaluria 5 3.0% 6 2.5% 11 2.7% 

PFIC 2 1.2% 8 3.3% 10 2.5% 

Byler's 1 0.6% 0 0.0% 1 0.2% 

Alagille 0 0.0% 1 0.4% 1 0.2% 

Budd Chiari 1 0.6% 1 0.4% 2 0.5% 

Re-transplantation 0 0.0% 0 0.0% 0 0.0% 

Others 47 28.1% 54 22.4% 101 24.8% 

Please note that there are some patients with more than one disease e.g. HCV+HBV or 

Viral+HCC etc, which contributes to the overall total for Table 2.1 more than the actual total per 

transplant location. The percentage for each reported original disease is calculated from the total 

transplantation from respective locations which is 167 from KFSH&RC and 241 from abroad. 

To give some detailed insights on the reported data, Figures 2.1 (a, b) shows 4 selected 

categories for the original diseases as isolated or combinations. 

Figure 2.1 (a): Distribution of Selected Indication (4 Categories) for Transplantation 

10


160 

150 

140 

120 

100 

80 

93 

72 

81 

60 

49 

40 

25 

20 

4 

10 

0 

HCV or HBV or Both Viral + HCC HCC without Viral Others 

KFSH&RC 

Abroad 

Figure 2.2 is an overall representation of data on the selected original diseases without their 

categorization with respect to the transplant locations. 

Figure 2.1 (b): Distribution of Selected Original Diseases (4 Categories) for Transplantation 

31.6% 

2.9% 

15.3% 

50.2% 

HCV or HBV or Both Viral + HCC HCC w ithout Viral Others 

Similarly, categorizing for six types of viral diseases Figure 2.2 (a, b) illustrate the distributions as 

follows: 

Figure 2.2 (a): Distribution of Selected Indication (6 Categories) for Transplantation 

11


60 

57 

50 

46 

40 

36 

30 

21 

24 

20 

17 

14 

11 

10 

3 

8 

0 

4 

0 

HCV (isolated) HBV (isolated) HCV+HBV HCV+HCC HBV+HCC HCV+HBV+HCC 

KFSH&RC 

Abroad 

Figure 2.2 (b): Distribution of Selected Original Diseases (6 Categories) for Transplantation 

14.5% 

1.7% 

14.5% 

42.7% 

4.6% 

22.0% 

HCV (isolated) HBV (isolated) HCV+HBV HCV+HCC HBV+HCC HCV+HBV+HCC 

12


Types of Liver Transplantation 

Worldwide, limitations on the availability of suitable donor organs continue to adversely affect 

mortality rates in candidates on the waiting list for organ transplantation. 

In KFSH&RC the patient is initially listed for the type of transplantation that needs to be carried 

out. Upon the availability of the donor for the transplantation (living or cadaveric), the 

transplantation procedure is carried out. 

Table 2.3 tabulates types of listing for the proposed type of transplantation. 

Table 2.3: Distribution of Type of Listing for Transplantation 



Unknown 0 0.0% 18 7.5% 18 4.4% 

Living Donor 55 32.9% 21 8.7% 76 18.6% 

Cadaveric 112 67.1% 202 83.8% 314 77.0% 

Total 167 241 408 

The number of recipients is constantly increasing while the number of donors remains relatively 

unchanged. This trend has led to a persistently widening gap between organ demand and organ 

supply. The first live-donor liver transplantation was performed in 1988 and was popularized by 

many centers. This approach offers the opportunity to eliminate waiting time, improve 

immunologic match, and reduce ischemia reperfusion injury by decreasing cold ischemia time. 

The total number of cases that underwent liver transplantation under each category of 

transplantation is tabulated in detail in Table 2.4. 

Table 2.4: Distribution for Type of Transplantation 



DDLT (Cadaveric) 110 65.5% 220 91.3% 330 80.7% 

LDLT (Living Donor) 57 33.9% 21 8.7% 78 19.1% 

Adult to Adult 46 80.7% 13 61.9% 59 75.6% 

Adult to Child 11 19.3% 8 38.1% 19 24.4% 

Total 167 241 408 

Adult to adult living-related liver transplantation represents a resource to be used in confronting 

organ shortage, and is a valuable option for decreasing mortality and drop out from the waiting 

list. All living donor liver transplantations (LDLT) were performed on “related living donors”. A 

13


total of (n=57; 33.9%) LDLT for related living donors were performed at KFSH&RC and a total of 

(n=21; 8.7%) were performed on cases coming from centers abroad. 

Table 2.5: Distribution of Graft Types used for LDLT Transplantation 



Whole Right 45 78.9% 12 92.3% 57 81.4% 

Whole Left 3 5.3% 1 7.7% 4 5.7% 

Left-Lateral Segment 9 15.8% 0 0.0% 9 12.9% 

Total 57 13 70 

The criteria for patient selection in case of liver transplantation for the HCC cases are based on 

the Milan’s Criteria. According to this criteria, for single lesion if the size of the lesion is


Pre-operative Details 

Before a transplant can be scheduled, various pre-operative details need to be carried out for 

necessary allocation of required resources. The tables below give details pertaining to such 

required resources. 

Table 2.8: Distribution of Blood Units for Transplantation 


Units of 

Blood KFSH&RC Abroad Total 

0 16 9.6% 225 93.4% 241 59.1% 

1 3 1.8% 2 0.8% 5 1.2% 

2 14 8.4% 0 0.0% 14 3.4% 

3 9 5.4% 0 0.0% 9 2.2% 

3.5 1 0.6% 0 0.0% 1 0.2% 

4 17 10.2% 1 0.4% 18 4.4% 

5 19 11.4% 2 0.8% 21 5.1% 

6 16 9.6% 3 1.2% 19 4.7% 

7 8 4.8% 1 0.4% 9 2.2% 

8 9 5.4% 0 0.0% 9 2.2% 

9 3 1.8% 1 0.4% 4 1.0% 

10 10 6.0% 2 0.8% 12 2.9% 

11 6 3.6% 0 0.0% 6 1.5% 

12 7 4.2% 1 0.4% 8 2.0% 

13 3 1.8% 0 0.0% 3 0.7% 

14 4 2.4% 0 0.0% 4 1.0% 

15 4 2.4% 0 0.0% 4 1.0% 

17 1 0.6% 0 0.0% 1 0.2% 

18 1 0.6% 1 0.4% 2 0.5% 

19 1 0.6% 0 0.0% 1 0.2% 

20 3 1.8% 0 0.0% 3 0.7% 

21 0 0.0% 1 0.4% 1 0.2% 

22 2 1.2% 0 0.0% 2 0.5% 

23 2 1.2% 0 0.0% 2 0.5% 

26 0 0.0% 1 0.4% 1 0.2% 

28 1 0.6% 0 0.0% 1 0.2% 

35 1 0.6% 0 0.0% 1 0.2% 

40 4 2.4% 0 0.0% 4 1.0% 

45 1 0.6% 0 0.0% 1 0.2% 

50 1 0.6% 0 0.0% 1 0.2% 

Total 167 241 408 

No data is entered for 241 cases, 16 patients from KFSH&RC and 225 from abroad, which points 

to the fact that no blood transfusion was required for these patients. 

The median number of blood transfusion units is 6 with a range between 0 to 50 units after the 

Liver Transplantation at KFSH&RC. 

15


Table 2.9: Distribution of Biliary Anastomosis 



Duct to Duct 138 82.6% 186 77.2% 325 79.4% 

REY 23 13.8% 50 20.7% 73 17.9% 

Combined 2 1.2% 0 0.0% 2 0.5% 


Total 167 241 408 

Table 2.10: Distribution of Primary Immunosuppressant for Transplantation 



FK506 in combination with others 141 84.4% 180 74.7% 321 78.7% 

Cyclosporine in combination with others 10 6.0% 39 16.2% 49 12.0% 

Cellcept in combination with others 72 43.1% 72 29.9% 144 35.3% 

Sirolimusin in combination with others 8 4.8% 9 3.7% 17 4.2% 

IL2 Inhibitors in combination with others 10 6.0% 5 2.1% 15 3.7% 

16


SECTION 3: COMPLICATIONS 

In this section various complications recorded for the registered cases (n=408) after the 

transplantation procedure are tabulated. In Table 3.1 the percentage for main categories of 

complications is calculated from the total count from respective transplant locations i.e. 167 for 

KFSH&RC and 241 for patients from abroad. 

Percentage for subgroups is calculated from the counts of main categories. 

Table 3.1: Distribution of Various Complications after Transplantation 



Primary Graft Non-Function 6 3.6% 2 0.8% 8 2.0% 

Post Operative Bleeding 19 11.4% 8 3.3% 27 6.6% 

Central pontine mylenolysis 2 1.2% 0 0.0% 2 0.5% 

Vascular 14 8.4% 19 7.9% 33 8.1% 

HAT 3 21.4% 4 21.1% 7 21.2% 

PVT 5 35.7% 3 15.8% 8 24.2% 

HAT+PVT 1 7.1% 2 10.5% 3 9.1% 


HAT+Others 1 7.1% 1 5.3% 2 6.1% 

Biliary Complications 34 20.4% 61 25.3% 95 23.3% 

Leak 2 5.9% 8 13.1% 10 10.5% 

Stricture 21 61.8% 44 72.1% 65 68.4% 

Biloma 0 0.0% 2 3.3% 2 2.1% 

Stricture+Biloma 2 5.9% 1 1.6% 3 3.2% 

Leak+Biloma 2 5.9% 1 1.6% 3 3.2% 

Stricture+Leak 6 17.6% 3 4.9% 9 9.5% 


Stricture+Others 0 0.0% 1 1.6% 1 1.1% 

Recurrent Disease 41 24.6% 72 29.9% 113 27.7% 

HCV 33 80.5% 54 75.0% 87 77.0% 

HBV 1 2.4% 14 19.4% 15 13.3% 

AIH 1 2.4% 1 1.4% 2 1.8% 

HCC 1 2.4% 0 0.0% 1 0.9% 

PSC 2 4.9% 0 0.0% 2 1.8% 

HCC+Others 1 2.4% 2 2.8% 3 2.7% 

HCV+Others 1 2.4% 1 1.4% 2 1.8% 

HCV+HCC+Others 1 2.4% 0 0.0% 1 0.9% 

17


Table 3.2: Distribution of Graft Failure after Transplantation 



Graft Failure 23 13.8% 26 10.8% 49 12.0% 

Patient's Death 16 69.6% 11 42.3% 27 55.1% 

Re-Transplantation 7 30.4% 14 14.0% 21 42.9% 


The cause of death in most of the registered cases is related to the transplantation as shown in 

Table 3.3. 

Table 3.3: Distribution of Patient’s Mortality after Transplantation 



Patient’s Death 24 14.4% 24 10.0% 48 11.8% 

Related to LTx 21 87.5% 20 83.3% 41 85.4% 

Not Related to LTx 3 12.5% 4 16.7% 7 14.6% 

18


SECTION 4: SURVIVAL ANALYSIS 

This section comprises of figures showing survival curves for the following groups: 

Patient Survival 

• Overall patient survival in KFSH&RC 

• Overall patient survival of non-KFSH&RC 

• HCV versus non-HCV in KFSH&RC 

• HCV versus non-HCV in non-KFSH&RC 

• HCC versus non-HCC in KFSH&RC 

• HCC versus non-HCC in non-KFSH&RC 

• DDLT versus LDLT in KFSH&RC only 

Graft Survival 

• Overall patient Graft in KFSH&RC 

• DDLT versus LDLT in KFSH&RC 

Figure 4.1: Overall Patient Survival in KFSH&RC 

19


Figure 4.2: Overall Patient Survival in non-KFSH&RC 

Figure 4.3: Patient Survival for HCV versus non-HCV in KFSH&RC 

( HCV, Non-HCV ) 

20


Figure 4.4: Patient Survival for HCV versus non-HCV in non-KFSH&RC 

Figure 4.5: Patient Survival for HCC versus non-HCC in KFSH&RC 

21


Figure 4.6: Patient Survival for HCC versus non-HCC in non-KFSH&RC 

Figure 4.7: Patient Survival for DDLT versus LDLT in KFSH&RC 

22


Figure 4.8: Overall Graft Survival in KFSH&RC 

Figure 4.9: Graft Survival for DDLT versus LDLT in KFSH&RC 

23


REFERENCES 

1. Al-Sebayel MI: The status of cadaveric organ donation for liver transplantation in Saudi 

Arabia. Saudi Med J 2002; 23:509. 

2. Khalaf h, Jovero r, Al-Sofayan M, Al-Sebayel M: The challenge of finding donors for living 

do--nor liver transplantation in Saudi Arabia. Transplant proc 2004; 36:2222. 

3. Al-Sebayel M, Khalaf H, Al-Sofayan M, Al-Saghier M, Abdo A, Al-Bahili H, El-Sheikh Y, 

Helmy A, Medhat Y. Experience with 122 consecutive liver transplant procedures at King 

Faisal Specialist Hospital and Research Center. Ann Saudi Med. 2007 Sep-Oct; 

27(5):333-8. 

24

Appendix I 

Case Report Forms

CONFIDENTIAL INFORMATION 

TO BE USED ONLY FOR THE LIVER TRANSPLANT PATIENT REGISTRATION 

PAN ARAB LIVER TRANSPLANTATION REGISTRY Patient Identification 

Demographics Data Acquisition Form 

King Faisal Specialist Hospital & Research Centre 

Riyadh, Saudi Arabia RAC#: 207 1022 

Patient ID Type: О NID О Iqama О Passport O Driving Licence Gender: Male 

PatientID Number: 

Female 

Registry Number: 

Institutional MRN: 

Patient's Name: ___________________________ (Family) 

_____________________________ (First) 

Date of Birth: Height: Weight: 

DD MM YYYY cm kg 

Transplantation Centre: 

Other Centres 

KSA Egypt China 

KFSH&RC Wady Al-Nile In Centre U.S.A 

KFNGH Dar Al-Fouad Outside Centre Germany 

Military National Liver Institute U.K. 

Others Mansoura University Others 

Lebanon International Medical Center KFSH&RC Old 

Jordan 

Cairo University 

Algeria Ain Shams University Date of Listing: O Living Donor O Cadaveric 

Others 


Date of Transplant: 

Pat. Blood Group: Blood Transfusion: Yes 

Type of Blood: О Whole О Plasma О Platelids No Date of Discharge: 

Units of Blood: 

Type of LT: DD MM YYYY 

Deceased Donor (DDLT) ICU stay: days 

Living Donor (LDLT) 

Adult-to-Adult Adult-to-Child Related Unrelated 

Graft used: 

Whole Right Whole Left Left-Lateral segment 

Graft/Recipient Weight Ratio (GRWR):________ Patient's Status after Surgery : Alive Dead 

Original Disease: 

Hepatitis C Virus (HCV) 

Primary Biliary Cirrhosis (PBC) 

Hepatitis B Virus (HBV) 

Secondary Biliary Cirrhosis (SBC) 

Hepatocellular Carcinoma (HCC) 

Primary Sclerosing Cholangitis (PSC) 

Number:________ Size of Each Lesion: Autoimmune Hepatitis (AIH) 

Total Size: _________ Alcoholic Liver Disease 

Vascular Invasion: Satelite Lesion: Wilson's 

Yes Yes Hemochromatosis 

No No Alpha-1-Antitrypsin Deficiency 

Hyperoxaluria 

Glycogen Storage Disease (GSD) 

Progressive Familial Intrahepatic Cholstateis (PFIC) 

Hypercholestremia 

Byler's 

Biliary Atresia 

Alagille's Syndrome 

Fulminant Hepatic Failure (FHF) 

Budd Chiari Syndrome 


Re-Transplantation 

Combined Liver & Kidney 

Biliary Anastomosis: 

Simultaneous (Date of Kidney Transplant) Duct-to-Duct (DD) 

Sequential 

Roux-en-Y (REY) 

DD MM YYYY Others 

Immunosuppression 

FK506 Cyclosporine Cellcept Myofortic 

Prednisolone Sirolimus Others IL2 inhibitor 

Filled By: 

Filled Date:

CONFIDENTIAL INFORMATION 

TO BE USED ONLY FOR THE LIVER TRANSPLANT PATIENT REGISTRATION 

PAN ARAB LIVER TRANSPLANTATION REGISTRY Patient Identification 

Complications-Follow Up Form 

King Faisal Specialist Hospital & Research Centre 

Riyadh, Saudi Arabia RAC#: 207 1022 

Registry Number: 

Complications: 

Primary graft non-function (PNF) 

Post-Operative Bleeding 

Central pontine mylenolysis (CPM) 

Comments: 

Vascular 

Hepatic Artery Thrombosis (HAT) 

Portal Vein Thrombosis (PVT) 


Infectious 

Abdominal 

Pulmonary 

Wound 

Biliary 


Biliary 

Recurrent Disease 

Leak 

HCV 

Stricture 

HBV 

biloma 

AIH 


PSC 

PBC 

Rejection No of Episodes: HCC 

Acute 

Alcohol 

Chronic 


Immunosuppressive Related 

Infections 

CMV 

EBV 

GI 

Pulmonary 


Renal 

Neurological 

Malignancies 

Post Liver Transplant 

Lymphoproliferative disorders (PTLD) 

Kaposi 


Diabetes 

Hypertension 

Myelotoxicity 

Graft Failure 

Patient Death 

Re-Transplantation 

( date of Re-transplantation) 

Others DD MM YYYY 

Death Death Cause: Related to LTX 

Date of Death: PNF Technical 

Bleeding 

Recurrent Disease 

DD MM YYYY Infection Rejection 


Maligancy 

Death Comments: 

Un-related to LTX 

General Comments: 

Filled By: 

Filled Date:

Appendix II 

Confidentiality Statement

King Faisal Specialist Hospital and Research Centre, Riyadh 

CONFIDENTIALITY STATEMENT 

Name: ID No. Position: 

Department: 

Institution: 

I declare that I understand and abide by the rules on confidentiality, security and release of information for users of the 

PanArab Liver Transplantation Registry as outlined below. 

(Print Name) 

(Signature) 

(Date) 

Rules of Confidentiality, Security and Release of Information for users of 

PanArab Liver Transplantation Registry Data 

1. Data held by Registries Core Facility at Biostatistics, Epidemiology and Scientific Computing Department on patients in PanArab Liver Transplantation Registry 

is intended for the purposes of Scientific Research and Statistical Analyses, Healthcare and Hospital Administration support only. The data cannot be used 

for any other purpose. 

2. Data received from PanArab Liver Transplantation Registryshould not be divulged to any person whose name is not specified as a co-user of the data nor 

should it be used for any other purposes than that declared in Registry Data Request Form. 

3. Proper safeguards should be applied in keeping and destroying the data upon completion of the work/project in order to prevent any breach of confidentiality. 

The Chairman of the Registry Committee should be notified immediately of any misuse or loss of data. 

4. No patient is to be contacted by a research worker as a result of information supplied by the registry without prior review and consent of the 

Registry Committee 

5. Any statistics or results of research based on data received from the registry should not be made available in a form which directly identifies individual data 

subjects and/or is not covered by the purpose of request specified in the Data Request Form.

Appendix III 

Release of Data Form

King Faisal Specialist Hospital and Research Centre, Riyadh 

Request for Data from PanArab Liver Transplantation Registry 

Name: ID No. Position: 

Department: Institution: MBC No. Ext. 

Date Requested: 

Date by which data is required: 

1. Data Requested (specify patient population, time period, etc.) 

A. Required Patient Information (specify variables. Use separate sheets if required) 

1. 3. 5. 

2. 4. 6. 

B. Time period From: To: 

2. Purpose of the request 

Presentation at conference/meeting 

Publication 

Other, please specify 

Spin-off Research Study 

Patient Care 

Other than Research (specify the reason and provide approval from the Chairman of the Department in your institution) 

3. Is the research study for which the data is requested, approved from Research Advisory Council (RAC)? 

Yes 

No 

If Yes, provide the RAC Number and attach a copy of the approval memo 

If No, explain the reasons 

4. If presentation or publication of data is anticipated, identify collaborators and co-authors to be credited: 

1. 2. 

3. 4. 

(Printed Name) 

(Signature) 

Request Received By: 

Confidentiality Statement signed 

Registrar, PanArab Liver Transplantation Registry Dated (DD/MM/YYYY) Yes No 

For PanArab Liver Transplantation Registry Committee 

Request Granted 

No 

Approved by: 

Principal Investigator(s): 

Yes 

If Yes, date request granted: 

Dated (DD/MM/YYYY) Chairman Registry Committee : 

For PanArab Liver Transplantation Registry Use Only 

Request Control Number: ---- Request Completed by: 

Date received: 

Completion date:

Appendix IV 

Confidentiality Policy

Registries Core Facility 

Biostatistics, Epidemiology and Scientific Computing Department 

King Faisal Specialist Hospital & Research Center 

Chapter: Three Section: Four 

Policy No. 03-04-01 

Policy: 

Registry Data – Release of Data and/or Information and Result Reporting Policy 

Issued: January 2002 Revised: December 2007 

General: 

Data collected by disease registries is directly related to the health care of the patients. This 

data collected on a hospital/national level is for research purposes available for 

researchers/doctors without disclosing patient’s identification. Any one interested in the 

registry data for research purposes has to submit their research project proposal for approval 

to the Office of Research Affairs (ORA) of King Faisal Specialist Hospital and Research 

Center. Once ORA approve the research project, the data can be made available by the 

registrar to the requestor after necessary documentation. 

Statement: 

1. Responsibility of Reporting the descriptive statistics based on the yearly collection of 

data in the form of an Annual Report rests upon the registrar of the relevant registry. 

2. Any request for release of information / data for research or other purposes should be 

processed by the Registrar who is responsible for documenting the request and informing 

the Registry Committee regarding the release of data from the registry. The data export 

facility from the web-database software will allow the registrar to furnish the data 

request. It should be made certain that the whole procedure is in conformity to the RCF 

Confidentiality Policy. Registrar is also responsible for maintaining the log of all such 

releases of information. 

Policy Objective: 

• To safeguard against unauthorized release of registry information. 

• To provide a smooth mechanism for the provision of registry data/information to 

authorized individuals. 

Application / Scope: 

All registries under RCF. 

Monitoring: 

Annual 

References 

RCF IPP # 03-05-01 Confidentiality Policy




Chapter: Three Section: Five 

Policy No. 03-05-01 

Policy: 

Confidentiality Policy 

Issued: January 2002 Revised: December 2007 

General: 

Since a disease registry requires the review of significant amounts of data there is normally a 

very thorough review of each patient's medical record. All information obtained on patients 

shall be considered extremely confidential. The actual medical record is the property of the 

hospital and is kept to document the course of a patient's care and provide communication 

between all health care professionals for both current and future care of the patient. The actual 

information contained within the medical record is the patient's property and cannot be released 

to anyone without proper authorization from the patient, a subpoena or court order. It is 

important to stress the strictest confidentiality, as new employees are hired as well as periodic 

reminders for other employees. RCF members have an obligation to safeguard the 

confidentiality of personal information maintained in the disease registries. This is governed by 

ethical and professional codes of conduct. Because of the rapid development of electronic 

processing of information making sensitive data widely available it is required by the users of 

sensitive data to ensure they also use common sense when handling data. Different professional 

and ethical considerations apply depending on the purpose for which the information is used. 

Policy Definition: 

Confidentiality 

Whilst RCF accepts that great benefits can be made from the information it has 

collected through disease registries and that medical professionals and hospital 

management should have ready access to the information they need, it is also 

important that personal information is kept confidential and that privacy is 

respected. Disciplinary action may result from a breach of confidentiality, where a 

breach of contract can be proved. 

Principles of Confidentiality 

a. The purpose for which data collected by the registry are to be used should be 

clearly defined. 

b. All disease registries in the RCF must maintain the same standards of 

confidentiality as customarily apply to the doctor-patient relationship; this 

obligation extends indefinitely, even after the death of the patient. 

c. Identifiable data may be provided to a clinician for use in the treatment of a 

particular disease / patient observing that only the data necessary for the stated 

purpose are released. Access to patient identifiable information should be on a 

strict need to know basis. Only those individuals who need access to patient 

identifiable information should have access to it, and they should only have access 

to the information items that they need to see. Use the minimum necessary patient 

identifiable information. 

d. The scope of confidentiality extends not only to identifiable data about data 

subjects and data suppliers, but also to others directly or indirectly identifiable data 

stored in or provided to the registry. 

e. Data on deceased persons should subject to the same procedures for confidentiality 

as data on living persons. 

2




f. Don't use patient identifiable information unless it is absolutely necessary. Patient 

identifiable items should only be used if there is no alternative. 

g. Everyone should be aware of their responsibilities. Action should be taken to 

ensure that those handling patient identifiable information, both clinical and nonclinical 

staff, are aware of their responsibilities and obligations to respect patient 

confidentiality. 

h. Guidelines for confidentiality apply to all data regardless of storage or transmission 

media. 

Policy Statement: 

1. Registrar of each registry is responsible for assuring the confidentiality and security 

of registry data. 

2. The RCF staff should sign, as part of their contract of employment, a declaration 

that they will not release confidential information to unauthorized persons. The 

declaration should remain in force after cessation of employment. They are also 

given a copy of the statement. It is essential that the requirements and 

responsibilities for people working with all the registries, record and databases 

maintained by Registries Core Facility (RCF) are clearly defined and understood. 

This policy outlines the steps that registry database users must adopt. 'Users' are 

authorized personnel to access any database. The policy also includes those staff 

members who are charged with the responsibility of creation, maintenance and 

development of registry databases and relevant software in Biostatistics, 

Epidemiology and Scientific Computing Department. 

3. Suitable control of access to the registry, both physical and electronic, and a list of 

persons, authorized to enter the registry should be maintained by the Registrar. 

4. The Registrar should maintain a list of staff members indicating the nature and 

extent of their access to registry data. 

5. Notices reminding staff of the need to maintain confidentiality should be promptly 

displayed. 

6. Registries at RCF should provide proof of identity to staff engaged in active patient 

registration. 

7. Identifiable data should not be transmitted by any means (post, telephone or 

electronic) without explicit authority from the Head, RCF or staff member to whom 

such authority has been delegated. Transmission by telephone should in general be 

avoided. 

8. Registries should consider the use of courier services for confidential data, as well 

as separating names from other data for transmission. 

9. Precautions should be taken for both physical and electronic security of 

confidential data sent on magnetic, optical or electronic media. This could be done 

by separating identifying information or via encryption of the identification. 

10. Use of computer for confidential data should be controlled for electronic and if 

possible physical measures to enhance the security of the data, including use of 

separate room, passwords, different levels of access to data, automatic logging of 

all attempts to enter the system, and automatic closure of sessions after a period of 

inactivity. 

11. Demonstration of the computer system / database management software should be 

performed with separate and fictitious or anonymous data sets. 

12. Special precautions should be taken for the physical security of electronic backup 

media. 

3




13. Expert advice on security against unauthorized remote electronic access should be 

sought if necessary. 

14. Measures should be taken to ensure the physical security of confidential records 

held on paper or any other media and to protect such data from corruption. 

15. A policy should be developed for the safe disposal of confidential waste. 

16. Security procedures should be reviewed at suitable intervals, and consideration 

should be given to obtaining specialist advice. 

17. Any unauthorized release of patient information will be punishable as stated in 

“Oath of Confidentiality”. 

Release of Data 

a. Release of registry data for research and for healthcare planning is central to the 

utility of a registry. The registry should develop procedures for data release that 

ensures the maintenance of confidentiality. 

b. The registrar is made responsible to present the request for identifiable data to the 

Registry Committee and make recommendations to the committee that the 

particular request meets the requirement of the law and the registry guidelines on 


c. In the absence of written consent from data subjects a registry should not release 

identifiable data on data subjects for the purpose other than research and statistics. 

National legislation with respect to confidential data should be observed. 

d. Physicians should be given access to data needed for the management of their 

patients if identified as such and if in accordance with national / institutional 

regulations. 

e. Enquiries from the press should be directed to the Chairman of the relevant 

Registry Committee or to a staff member nominated for this purpose. 

f. Requests for identifiable data to be used for research should include a detailed 

justification with a commitment to adhere to the registry’s guidelines on 


g. Registries should provide a document describing their procedures and criteria for 

the release of data especially identifiable data to researchers who request access to 

the data. 

h. If allowed by the institutional and/or national regulations, cross-border transfer of 

identifiable individual data should only be carried out if required for the conduct of 

a research project and if the level of protection is satisfactory. 

Policy Objective: 

• The need for a code of conduct in the maintenance of confidentiality in disease registries 

and the definition of what should be considered confidential. 

• The principles of confidentiality including measures to maintain and survey security 

procedures. 

• Guidelines for the preservation of confidentiality and for the use and release of registry data 

in accordance with these principles. 

Application / Scope: 

All registries under RCF 

4

Appendix V 

PALTS Registry ByLaws

PanArab Liver Transplantation Registry 

Bylaws 

ARTICLE I 

SECTION 1.1 

GENERAL 

The name of this Registry shall be “The PanArab Liver Transplantation Registry” 

(henceforth known as “REGISTRY”) 

SECTION 1.2 

The PanArab Liver Transplantation Registry shall be considered as the official 

registry of the “PanArab Liver Transplantation Society” (henceforth known as 

“PALTS”) 

SECTION 1.3 

The registry was initially suggested during the activities of the 1st PanArab Liver 

Transplantation Congress that was held in Cairo, March 2006. The registry 

proposal was submitted and approved by PALTS founding members in the 2nd 

PanArab Liver Transplantation Congress that was held in Riyadh, March 2007. 

SECTION 1.4 

The registry is a “web-based registry”. This sophisticated web-based registry 

software is using a relational database on Microsoft Internet Information Server 

(IIS) to store and manage the registry data. This database is residing on a secure 

dedicated server. The application can be accessed through the Internet. Users 

can log-in data from their respective hospitals / health centres without any fear of 

their data access by another hospital. This is possible due to the segregation of 

data between various hospitals. Access to the registry data is password 

protected with encryptions and is restricted to authorized users only. 

SECTION 1.5 

The registry is hosted by the Registries Core Facility (RCF), Department of 

Biostatistics, Epidemiology and Scientific Computing (BESC), King Faisal 

Specialist Hospital and Research Center (henceforth known as “HOSTING 

INSTITUTE”). However, the registry is the sole property of PALTS. 

SECTION 1.6 

All liver transplant programs in the Arab World are welcomed and encouraged to 

contribute to the Registry in accordance with the Registry’s Bylaws

ARTICLE II 

PURPOSE and MISSION 

SECTION 2.1 

The registry shall quantify the liver transplant activities in Arab World which will 

be thereafter summarized in the Registry’s Annual Report. 

SECTION 2.2 

The registry shall evaluate the extent and pattern of liver diseases in Arab world, 

and shall assess the need for Liver Transplantation in different Arab Countries. 

SECTION 2.3 

The Registry shall promote and encourage education, research and cooperation 

in the field of liver transplantation between various liver transplant programs in 

the Arab World. 

SECTION 2.4 

The Registry shall create a scientific forum for discussion of all problems related 

to liver transplantation in the Arab World including medical, ethical, social and 

legal aspects. 

ARTICLE III 

SECTION 3.1 

MEMBERSHIP 

All liver transplant programs in the Arab World are welcomed and encouraged to 

contribute to the Registry as members in accordance with the Registry’s Bylaws. 

SECTION 3.2 

Any contributing liver transplant program shall be henceforth known as 

“MEMBER” 

SECTION 3.3 

Members are obliged to abide by the Registry’s Bylaws

SECTION 3.4 

Members shall be requested to set-up a satellite centre for the registry at their 

premises and to contribute their data to the Registry in accordance with the 

Registry’s Bylaws. 

SECTION 3.5 

Members shall be requested to assign a “Registrar” who will be responsible for 

using the web-based registry software after receiving the appropriate training. 

SECTION 3.6 

Each contributing liver transplant program shall be represented in the Registry 

Committee by one member-at-large (Article IV, Section 3). 

SECTION 3.7 

Any member may resign by submitting a resignation in writing to the Chairman of 

the Registry Committee. 

SECTION 3.8 

Any membership can be terminated by the registry committee, which in the sole 

judgment of the committee is injurious to the interests or welfare of the whole 

registry, or for failure abide by the registry bylaws. Such a termination shall 

require a two-thirds vote of the Registry Committee after the member in question 

is afforded an opportunity to appear before the Committee to appeal for 

continuance of membership. 

ARTICLE IV 

SECTION 4.1 

REGISTRY COMMITTEE 

The business and property of the Registry shall be managed by a “Registry 

Committee” which shall be identified as one the PALTS recognized committees, 

and shall be henceforth known as “COMMITTEE” 

SECTION 4.2 

The committee shall be responsible for managing all registry affairs, and shall 

determine mechanisms of access to the registry data, frequency of reporting, 

reviewing the reports, publications from the registry data and approval of release 

of data for research purposes

SECTION 4.3 

The Committee shall consist of: 

a. One member-at-large from each contributing organization. 

b. One member-at-large representing PALTS 

c. Principal Investigator (PI) of the registry who will is appointed by the 

hosting institute in consultation with PALTS president. 

d. Coordinator/Registrar with a non-voting status (Article V, Section 5) 

e. Scientific Advisor with a non-voting status (Article V, Section 6) 

f. Member Technical with a non-voting status (Article V, Section 7) 

SECTION 4.4 

Committee members shall serve for a two-year term. 

SECTION 4.5 

Committee members shall serve without compensation. 

SECTION 4.6 

Regular meetings of the committee shall be held annually during the annual 

meeting of the Society. Special meetings of the committee may be held at any 

time or place upon the call of the chairman or of any five members-at-large. 

Notice of meetings shall be given and must be written and mailed to each 

member by the registry coordinator not less than fourteen days before such 

meeting. Meetings may be held at any time or place and without notice if all 

members are present, or if those not present waive notice thereof, in writing, 

either before or after the meeting. 

SECTION 4.7 

At any meetings of the members, properly called and announced, the number of 

members appearing for said meeting shall constitute the quorum necessary for 

transaction of the business of the meeting. 

SECTION 4.8 

Members may vote by proxy in the registry committee meetings. 

SECTION 4.9 

An action required or permitted to be taken at any meeting of the Committee may 

be taken without a meeting if, following written notice of the proposed action to all 

members of the Committee, a majority of the members Committee consent 

thereto in writing or by conference telephone call confirmed by written minutes 

submitted to the Chairman. All written consents and any dissenting views shall 

be filed with the minutes of the Committee as the case may be.

SECTION 4.10 

Minutes shall be kept of all Committee meetings and shall be submitted to the 

Council for approval. 

ARTICLE V 

SECTION 5.1 

OFFICERS 

The officers of the Registry shall be Chairman, Deputy Chairman, Treasurer, 

Coordinator/Registrar, Scientific Advisor, and Member Technical. The officers 

shall comprise the Executive Committee and will be responsible for general 

supervision of the Society’s daily business affairs. 

SECTION 5.2 

Chairman: shall be appointed by PALTS president in accordance with PALTS 

bylaws, and in consultation with the hosting institute. The chairman shall have 

signatory authority for all registry activities compiled by the registry bylaws. The 

chairman shall be responsible; for presiding over the Registry Committee 

meetings, making sure Registry Bylaws are being followed, approval of the 

registry budget, spearheading the fund raising efforts, representing the Registry 

to outside organizations, publishing the registry Annual Report compiled by 

registry bylaws (Article VI), and release of registry data compiled by registry 

bylaws (Article VII) 

SECTION 5.3 

Deputy Chairman: shall be appointed by the registry chairman and is necessarily 

a member of the registry committee. He will take all responsibilities of the 

Chairman in his/her absence 

SECTION 5.4 

Treasurer: shall be appointed by the registry chairman and is necessarily a 

member of the registry committee. He shall be responsible for looking after the 

financial interests of the registry. He will also be responsible for reporting on the 

monetary situation of the registry on annual basis. 

SECTION 5.5 

Coordinator/Registrar: shall be appointed by the chairman in consultation with 

the hosting institute, and shall have a non-voting status. He shall be responsible 

for calling for the committee meetings, formulating the agenda, keeping the 

minutes, liaise with the hosting institute as a representative of the Registry, 

facilitates the release of data compiled by registry bylaws, responds and reports 

to the Chairman, concerns, problems or conflict issues arising during the routine

functionality of the registry and coordinates the solution to the Chairman of the 

Registry Committee. 

SECTION 5.6 

Scientific Advisor: shall be appointed by the registry chairman in consultation with 

the hosting institute, and shall have a non-voting status. He shall be responsible 

for providing his expert opinion on collection and analysis of data. 

SECTION 5.7 

Member Technical: shall be appointed by the registry chairman in consultation 

with the hosting institute, and shall have a non-voting status. He/She is 

necessarily a member of the Registries Core Facility, Department of Biostatistics, 

Epidemiology and Scientific Computing (BESC), King Faisal Specialist Hospital 

and Research Center. He/She shall make sure that registry data is safe and 

secure, the registry IPPs are placed and being followed, and will solve all 

technical issues involved in the successful functioning of the registry. 

SECTION 5.8 

Officers and committee members shall serve for a two-year term. 

SECTION 5.9 

Officers and committee members shall serve without compensation. 

ARTICLE VI 

SECTION 6.1 

ANNUAL REPORT 

The registry shall produce an annual report that will be printed and presented 

during the annual PALTS congress. 

SECTION 6.2 

All members must unconditionally agree to contribute their data to the Annual 

Report; this is a perquisite for PALTS Registry Membership. 

SECTION 6.3 

The responsibility of reporting the descriptive statistics based on the yearly 

collection of data in the form of an Annual Report rests upon the Chairman and 

Registrar of the registry

SECTION 6.4 

The Annual Report must be approved by the Registry Committee before its 

release. 

SECTION 6.5 

The annual report shall contain the following information: 

a. Number and Type of liver transplant procedures performed in the Arab 

World (overall, per-country, and per-center) 

b. Patients Demographics (overall and per country) 

c. Indications of liver transplant in the Arab World (overall and per country) 

d. Patient and Graft survivals in the Arab World (overall and per country) 

SECTION 6.6 

The annual report shall NOT contain the following information: 

a. Identifiable Patients Data 

b. Patients Demographics per-center 

c. Indications per-center 

d. Outcome per-center 

e. Patient and Graft survival per-center 

SECTION 6.7 

Any additional information other than those listed in these bylaws, should be 

discussed and unanimously approved by Registry Committee before including it 

in the Annual Report. 

ARTICLE VII 

SECTION 7.1 

RELEASE OF DATA 

Under no circumstances may Registry Data be released for any purpose 

without the prior approval of the Registry Committee as well as the written 

approval of each of the concerned member/institution. 

SECTION 7.2 

Each member/institution shall be given full access to its own data only, however, 

they will have no access what so ever to other member/institution data.

SECTION 7.3 

Each member/institution has the absolute right to refrain from contributing their 

data for research or other purposes except for the Annual Report as stated in 

these bylaws (Article VI, Section 2) 

SECTION 7.4 

Any request for release of information / data for research or other purposes 

should be processed by the Registry Chairman who is responsible for presenting 

the request to the Registry Committee, getting the approval and downloading the 

relevant data. It should be made certain that the whole procedure is in conformity 

to confidentiality guidelines (Article VIII). The Registry Registrar is also 

responsible for maintaining the log of all such releases of information. 

SECTION 7.5 

Requests for identifiable data to be used for research should include a detailed 

justification with a commitment to adhere to the registry’s guidelines on 


SECTION 7.6 

Enquiries from the press should be directed to a committee member nominated 

for this purpose in consultation with the Registry’s Chairman. 

ARTICLE VIII 

SECTION 8.1 

CONFIDENTIALITY GUIDELINES 

Any data collected and stored by the registry which could permit the identification 

of an individual patient (data subject) or, in relation to a particular data subject, of 

an individual physician or institution (data supplier) are considered to be 

confidential. 

SECTION 8.2 

Data collected by disease registries is directly related to the health care of the 

patients. This data or any other information related to the patients’ health care is 

the property of the patient and cannot be released to an unauthorized individual 

without prior consent from the registry committee. 

SECTION 8.3 

All Registry members and staff should sign a declaration stating that they will not 

release confidential information to unauthorized persons.

SECTION 8.4 

The Registrar is responsible for: 

a. Assuring the confidentiality and security of registry data 

b. Maintaining a list of staff members indicating the nature and extent of their 

access to registry data. 

c. Maintaining suitable control of access to the registry, both physical and 

electronic, and a list of persons, authorized to enter the registry 

d. Making sure that the previously described procedures for data release is 

always followed to ensure the maintenance of confidentiality registry 

ARTICLE IX 

SECTION 9.1 

FINANCIAL AFFAIRS 

The registry is a non-profit research project geared towards maximizing 

healthcare delivery to our patients in the Arab World, therefore, this project 

should be looked at as a destiny of philanthropic orientation. 

SECTION 9.2 

The Registry Committee will use all its resources to solicit the funding to this 

project. An account of such donations will be opened under the name of the 

“PanArab Liver Transplantation Registry” and will be maintained by a certified 

accountant under the direct supervision of the Treasurer. 

SECTION 9.3 

An audit of the Registry's financial status shall be performed yearly, and the 

results of this audit shall be presented by the Treasurer to the Committee at the 

annual meeting. 

ARTICLE X 

SECTION 10.1 

AMENDMENT OF BYLAWS 

Members of the Registry Committee may propose amendments to these Bylaws. 

Any voting member may propose amendments provided such amendments are 

accompanied by written endorsement of at least one third of the additional voting 

members.

SECTION 10.2 

Proposed amendments to these Bylaws shall be submitted to the Chair of the 

Committee at least sixty days (60) prior to the Registry Committee meeting. 

SECTION 10.3 

A two-thirds (2/3) vote of the voting member present at the meeting at which a 

quorum has been established shall be required to adopt any amendment. Unless 

stated otherwise, the amendments shall become effective upon adoption. 

SECTION 10.4 

Amendment in the Registry Committee bylaws can only be done once a year. 

SECTION 10.5 

A copy of the proposed amendments shall be sent to the voting members at least 

thirty days (30) prior to the Registry Committee meeting. 

ARTICLE XI 

SECTION 11.1 

EXECUTIVE OFFICE 

The Executive Office of the Registry shall be located at the premises of the 

hosting institute. 

SECTION 11.2 

At the time of writing these bylaws, the Executive Office of the Registry is located 

at: 

Registries Core Facility (RCF), MBC 03 

Department of Biostatistics, Epidemiology and Scientific Computing (BESC), 

MBC 03 

King Faisal Specialist Hospital and Research Center (KFSH&RC) 

Riyadh, 11211 

Kingdom of Saudi Arabia 

Phone: +966 1 4424868 

Fax: +966 1 4424542 

E-mail: registry@palts.org

Pan Arab Liver Transplantation Registry - the Research Centre Page

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