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OpenTrials
Completed

NCT Number: NCT00888784

Secondary Prophylaxis Gastric Variceal Bleed

The investigators conducted a randomized, controlled trial (RCT) to study the efficacy of beta blockers versus endoscopic cyanoacrylate injection in the prevention of gastric variceal (GOV2 or IGV1) rebleeding and improvement in survival.

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Key information

Conditions

Cirrhosis Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

10 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

G B Pant Hospital

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with GOV2 without esophageal varix or IGV1, who had bled from GV were included

Exclusion criteria

  • Presence of esophageal varix
  • GOV2 with GOV1; contraindications to beta-blocker therapy and cyanoacrylate injection
  • Prior injection of cyanoacrylate or sclerotherapy for GV or GV ligation, transjugular intrahepatic portosystemic shunt, balloon-occluded retrograde transvenous obliteration, balloon-occluded endoscopic injection sclerotherapy of GV, shunt operation for prevention of rebleeding 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 or 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

beta-blocker (propranolol)

Drug

Propranolol was started at a dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose was increased every alternate day to achieve a target heart rate of 55/min or to the maximal dose to 360 mg/day if the medication was well tolerated and the systolic blood pressure was >90 mm Hg. On the occurrence of intolerable adverse effects, systolic blood pressure <90 mm Hg or pulse rate <55/min, the dose of the medication was decreased step-wise, and eventually stopped if these adverse events persisted. Reintroduction of the medication was attempted if cessation of the medication did not result in improvement of the reported side-effect.

Primary outcomes

  1. Rebleeding from GV or death

    Time frame: Overall Study

Secondary outcomes

  1. Increase or decrease in the size of GV, appearance of new esophageal varices and appearance or worsening of portal hypertensive gastropathy and complications.

    Time frame: Overall Study

Sponsors and collaborators

Lead sponsor

Govind Ballabh Pant Hospital

Other Gov

Registry information

Official study title

Endoscopic Cyanoacrylate Injection Versus Beta-Blockers for Secondary Prophylaxis of Gastric Variceal Bleed

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Apr 28, 2009
Registry last updated
Apr 28, 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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