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

Institute of Liver and Biliary Sciences, India

Status and phase: Withdrawn; Phase 3

Conditions: Bleeding Gastric Varices

Treatments: Procedure: Endoscopic Ultrasound assisted endoscopic glue injection; Procedure: Standard Endotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01631890

ILBS- EUS-001

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

standard endotherapy

Active Comparator group

Treatment:

Procedure: Standard Endotherapy

Endoscopic Ultrasound assisted endoscopic glue injection

Experimental group

Treatment:

Procedure: Endoscopic Ultrasound assisted endoscopic glue injection