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NCT05677230
To Compare the Safety and Efficacy of Balloon Occluded/Plug Assisted Retrograde Transvenous Obliteration With Endoscopic Variceal Obturation for Primary Prophylaxis of Gastric Varices With Large Spontaneous Shunt
Conditions: Liver Cirrhosis
Sex: All
Ages: 18 Years – 75 Years
Phase: NA
Enrollment: 60
Sponsor: Institute of Liver and Biliary Sciences, India
Location: India
Summary
Study population: All the consecutive patients of cirrhosis who are diagnosed to have large gastric varices without prior history of bleeding from GV, who came to OPD or endoscopy in Hepatology department of ILBS will be evaluated for inclusion.Study design: Prospective interventional study.
The study will be conducted in the Department of Hepatology ILBS.Study period: 1.0 yearsSample size: 60This is a pilot RCT, and we decided to enroll 30 patients in each arm.
Eligibility Criteria
Inclusion Criteria:Age 18-75 yearsCirrhotic patients, with GV (GOV2 or IGV1) with eradicated or small low risk esophageal varices with gastrorenal shunt of >10 mm size amenable for BRTO/PARTO.Exclusion Criteria:Non-cirrhotic portal hypertension,History of bleeding from GVHepatic encephalopathy grade III/IV,Acute kidney injuryPatients on beta blocker therapy for > 6 months prior to enrollment in studyHepatocellular carcinomaPortal venous thrombosisPresence of jaundice (bilirubin >3 mg/dl), ascites, Child C, MELD > 18Advanced cardiac or pulmonary diseasesPregnancyPatients not giving informed consent
Source: ClinicalTrials.gov (NCT05677230). StuddyBuddy aggregates publicly available trial information.