Primary Prophylaxis of Gastric Varix Bleed

A Randomized Controlled Trial Comparing Cyanoacrylate Injection Versus Beta-Blockers Versus No Treatment for Primary Prophylaxis of Gastric Variceal Bleed

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00905996

Enrollment

Registered

2009-05-21

Start date

2006-08-31

Completion date

2009-01-31

Last updated

2009-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis

Brief summary

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.

Detailed description

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

Interventions

PROCEDUREEndoscopic cyanoacrylate injection

Endoscopic cyanoacrylate injection in gastric varix

DRUGBeta-blocker (propranolol)

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

12 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Bleeding from gastric varix or death	Within 2 years

Secondary

Measure	Time frame
Increase or decrease in the size of gastric varices, appearance of new esophageal varices and appearance or worsening of portal hypertensive gastropathy (PGP), complications	Within 2 years

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026