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OpenTrials
Completed

NCT Number: NCT00905996

Primary Prophylaxis of Gastric Varix Bleed

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.

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Key information

Conditions

Cirrhosis Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

12 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shiv K Sarin

New Delhi, National Capital Territory of Delhi, 110002, India

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic Cyanoacrylate injection

Procedure

Endoscopic cyanoacrylate injection in gastric varix

Other names: Glue injection in gastric varix

beta-blocker (propranolol)

Drug

Primary outcomes

  1. Bleeding from gastric varix or death

    Time frame: Within 2 years

Secondary outcomes

  1. 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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Govind Ballabh Pant Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
May 21, 2009
Registry last updated
May 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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