To Compare the Efficacy of Endoscopic Ultrasound Assisted Endoscopic Glue Injection and Conventional Endoscopic Injection Therapy for Prevention of Gastric Variceal Rebleed

Phase 3

Withdrawn

• Conditions: Bleeding Gastric Varices
• Interventions: Procedure: Standard Endotherapy; Procedure: Endoscopic Ultrasound assisted endoscopic glue injection

• Registration Number: NCT01631890
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief Summary

Consecutive patients who meet the eligibility criteria will be enrolled into the study. All patients with gastric varices with no history of gastric variceal bleed (Group C) will undergo Endoscopic ultrasound and Upper Gastrointestinal Endoscopy at baseline, at the end of first year and at the end of study.

The patients who presented to Institute of Liver and Biliary Sciences with gastric variceal bleed or develop Gastric Variceal bleed during hospital stay will be randomized into Group -A (conventional Upper Gastrointestinal Endoscopy + Glue) and Group-B (Endoscopic Ultrasound followed by Upper Gastrointestinal Endoscopy+Glue) therapy for gastric varices. Total 90 patients will be enrolled and randomized into group A and Group B after resuscitation and urgent Upper Gastrointestinal Endoscopy with standard therapy for bleeding gastric varices to achieve hemostasis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-06
• Study Start: 2012-06
• Study First Submitted: 2012-06-14
• Study First Submitted QC: 2012-06-28
• Study First Posted: 2012-06-29
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Last Update Submitted: 2015-11-07
• Last Update Posted: 2015-11-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• A clinical, radiological or histologic diagnosis of cirrhosis
• Upper Gastrointestinal endoscopy showing gastric varices
• Informed consent to participate in the study

Exclusion Criteria

• Previous endotherapy (Endoscopic Variceal Ligation/Esophageal Variceal Sclerotherapy/Endoscopic Variceal Obliteration) for gastric variceal haemorrhage
• Diagnosed case of HepatoPulmonary Syndrome.
• Non -cirrhotic portal hypertension/Extra hepatic Portal Venous Obstruction
• transhepatic intrajugular portosystemic shunt, (balloon-occluded retrograde transvenous obliteration), balloon-occluded endoscopic injection sclerotherapy, shunt operation.
• Hepatic encephalopathy grade III/IV,
• Cardio respiratory failure
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard endotherapy	Standard Endotherapy	-
Endoscopic Ultrasound assisted endoscopic glue injection	Endoscopic Ultrasound assisted endoscopic glue injection	-

Primary Outcome Measures

Name	Time	Method
Proportions of patients with gastric varices develops rebleed after complete gastric varices obturation in 2 years	2 years

Secondary Outcome Measures

Name	Time	Method
Proportions of patients who will show adverse effects of gastric variceal obturation by N Butyl cyanoacrylate.	2 years
Proportion of patients who will achieve complete Gastric variceal obliteration in both groups	2 years

Trial Locations

Locations (1)

Institute of Liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India