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

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: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Liver Cirrhosis

Interventions

Type	Name	Description
PROCEDURE	Balloon occluded/plug assisted retrograde transvenous obliteration.	Balloon occluded/plug assisted retrograde transvenous obliteration will be done one time only.
PROCEDURE	Endoscopic Variceal Obturation	Endoscopic Variceal Glue Therapy will be done till obturation every 3 weekly.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-12-09
• Completion: 2024-12-09
• First posted: 2023-01-10
• Last updated: 2025-05-01

Locations

1 site across 1 country: India