Primary Prophylaxis of Gastric Varix Bleed

Govind Ballabh Pant Hospital74 enrolled

Overview

In patients who have never bled from gastric varix (GOV2 and IGV1), cyanoacrylate injection will be better than both beta-blocker therapy and no treatment in prevention of gastric variceal bleed. The investigators conducted a randomized controlled trial in patients with gastric varix (GOV2 and IGV1) who never bled before, to study the efficacy of treatment with cyanoacrylate injection versus beta-blocker versus no treatment in prevention of first bleed from gastric varices.

Patients are followed up every 3 months or at the time of end point or complications.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Cirrhosis

Interventions

Endoscopic cyanoacrylate injectionPROCEDURE

Endoscopic cyanoacrylate injection in gastric varix

Beta-blocker (propranolol)DRUG

Eligibility

Sex: ALLMin age: 12 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with GOV2 with eradicated esophageal varix or IGV1, who had never bled from gastric varix were included. Exclusion Criteria: * Only esophageal varix, GOV1 with GOV2, acute bleed or past history of bleed from gastric varix, contraindications to beta-blocker therapy and cyanoacrylate injection. * Prior injection of cyanoacrylate or sclerotherapy or variceal ligation or transjugular intrahepatic portosystemic shunt or balloon-occluded retrograde transvenous obliteration or balloon-occluded endoscopic injection sclerotherapy of gastric varix for prevention of bleeding from GV * Patients already on beta-blocker or nitrates * Undetermined origin of bleeding from esophageal varix or gastric varix * Hepatic encephalopathy grade III/IV * Hepatorenal syndrome * Hepatocellular carcinoma * Presence of deep jaundice (serum bilirubin \> 10 mg/dl) * Uremia * Cerebrovascular accident * Cardiorespiratory failure * Pregnancy and patients not giving informed consent for endoscopic procedures

Locations (1)

Shiv K Sarin

New Delhi, National Capital Territory of Delhi, India

Outcomes

Primary Outcomes

Bleeding from gastric varix or death

Time frame: Within 2 years

Secondary Outcomes

Increase or decrease in the size of gastric varices, appearance of new esophageal varices and appearance or worsening of portal hypertensive gastropathy (PGP), complications

Time frame: Within 2 years

Data from ClinicalTrials.gov

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