studies

HEPATOLOGY, VOLUME 62, NUMBER 1 (SUPPL) AASLD ABSTRACTS 361A
was observed between the two groups of patients as far as
demographic, clinical, hemodynamic, and laboratory characteristics.
No treatment was provided for Grade 1 ascites in
the study. During the follow up twenty-two patients developed
Grade 2 or 3 ascites, 14 in Group A (14,7 %) and 8 in Group
B (25.0%, p = N.S.). In only 4 out of 14 patients of Group A,
Grade 1 ascites was detected before they developed Grade 2
or 3 ascites. The mean time for the development of Grade 2
or 3 ascites was shorter in Group B than in Group A, but the
difference was not statistically significant (17,00 ± 11,06 versus
32,29 ± 27,59 months, p = N.S.). In nineteen patients in
Group B (59.3%), Grade 1 ascites disappeared during the follow
up. At univariate analysis, the finding of Grade 1 ascites,
MELD, spleen diameter and the ratio platelets/spleen diameter
were found as potential predictors of Grade 2 or 3 (Table). At
multivariate analysis only the ratio platelets/spleen diameter
was found to be the only independent predictor of Grade 2 or
3 ascites (HR = 0,997, 95%, CI : 0,994; 0,999, p = 0,0018
per el/mm 3 /mm of increase). In conclusion, the presence of
Grade 1 ascites is neither a precursor nor an independent
predictor of Grade 2 or 3 ascites in patients with cirrhosis.
Thus, Grade 1 ascites does not require any treatment, including
sodium dietary restriction.
Disclosures:
Paolo Angeli - Advisory Committees or Review Panels: Sequana Medical
The following authors have nothing to disclose: Marta Tonon, Salvatore Piano,
Matjaz Grbec, Chiara Pilutti, Silvano Fasolato, Antonietta Romano, Sara Montagnese,
Filippo Morando, Massimo Bolognesi, Marialuisa Stanco, Giancarlo
Bombonato, Silvia Rosi, Elisabetta Gola, Antonietta Sticca
293
Validation of Ascites-specific Patient Reported Outcome
Questionnaires for Patients with Cirrhosis
Patrick S. Kamath 3 , Myrte Neijenhuis 3 , Tom J. Gevers 2 , Thomas
Atwell 1 , Joost Drenth 2 , Tim Gunneson 3 ; 1 Division of Gastroenterology,
Hepatology & Internal Medicine, Mayo Clinic College of
Medicine, Rochester, MN; 2 Gastroenterlogy and Hepatology,
Radboud University Nijmegen Medical Centre, Nijmeten, Netherlands;
3 Division of Gastroenterology and Hepatology, Mayo
Clinic, Rochester, MN
Background and aim: Since no treatment improves long-term
survival, treatment of ascites should focus on symptom relief
and prevention of complications. No patient reported outcomes
have been used as endpoints in clinical trials in cirrhotic ascites.
We aimed to identify a sensitive tool to measure symptoms
in cirrhotic ascites. Methods: We identified 12 ascites-specific
symptoms (fullness, lack of appetite, early satiety, nausea,
abdominal pain, back pain, dyspnea, limited mobility, fatigue,
insomnia, dissatisfaction with size of abdomen and sexual intimacy
problems) based on literature, patient interviews (n=8)
and clinician survey (n=8) to develop an ascites-specific questionnaire
(Ascites-Q). We administered Ascites-Q; Japanese
Ascites Symptom Inventory-7 (ASI-7, developed for cirrhotic
ascites); FACIT-ascites index (developed for malignant ascites);
and quality of life (QoL) VAS-scale in cirrhotic patients undergoing
large volume paracentesis (target sample size n=90).
Scores were transformed to a 0-100 scale with higher scores
indicating more symptoms. To identify ascites-specific symptoms,
we compared using the Mann Whitney U test scores
of patients with refractory ascites prior to paracentesis with
scores in cirrhotic patients with no ascites recruited at the Mayo
Clinic between January - May 2015. Correlations of QoL VASscale
and ascites questionnaires were calculated (Spearman).
Responsiveness of questionnaires to detect changes in symptoms
was assessed by comparing scores at baseline and 7
days post paracentesis (paired T-test). Results: We included 32
patients with refractory ascites requiring large-volume paracentesis
(59% male, mean age 61 yr, MELD-score 15 and median
paracentesis volume 3600 mL; and 61 patients without refractory
ascites (controls) (76% male, mean age 57 yr, MELD-score
11). Patients with refractory ascites scored higher than controls
on all symptoms of Ascites-Q and ASI-7, except for Ascites-Q
symptoms back pain (p=0.096) and fatigue (p=0.228). There
was no difference between patients and controls in 6/13 FAC-
IT-ascites index symptoms (insomnia, limited mobility, nausea,
vomiting, polyuria and emotional distress). QoL correlated with
Ascites-Q and ASI-7 (r=.497, p=0.008 and 0.471, p=0.013),
but not with FACIT-ascites index (r=0.332, p=0.090). Scores
of Ascites-Q, (-11.53 ± 18.874, p=0.013), ASI-7 (-35.46, ±
29.22, p