CompletedNot Applicable

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

India56 participantsStarted 2023-01-01

Plain-language 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 years Sample size: 42

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Age 18-75 years
✓. Cirrhotic 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 GV
✕. Hepatic encephalopathy grade III/IV,
✕. Acute kidney injury
✕. Patients on beta blocker therapy for \> 6 months prior to enrollment in study
✕. Hepatocellular carcinoma
✕. Portal venous thrombosis
✕. Presence of jaundice (bilirubin \>3 mg/dl), ascites, Child C, MELD \> 18

What they're measuring

Proportion of patient having bleeding from GV at 12 months

Timeframe: 6 months

Trial details

NCT IDNCT05677230

SponsorInstitute of Liver and Biliary Sciences, India

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-09

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