Secondary Prophylaxis Gastric Variceal Bleed

Not Applicable

Completed

• Conditions: Cirrhosis
• Interventions: Procedure: Endoscopic Cyanoacrylate injection; Drug: beta-blocker (propranolol)

• Registration Number: NCT00888784
• Lead Sponsor: Govind Ballabh Pant Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2009-04
• Study First Submitted: 2009-04-27
• Study First Submitted QC: 2009-04-27
• Last Update Submitted: 2009-04-27
• Study First Posted: 2009-04-28
• Last Update Posted: 2009-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1. Endoscopic Cyanoacrylate injection	Endoscopic Cyanoacrylate injection	Endoscopic Cyanoacrylate injection in the gastric varix
2. Beta-blocker	beta-blocker (propranolol)	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 Outcome Measures

Name	Time	Method
Rebleeding from GV or death	Overall Study

Secondary Outcome Measures

Name	Time	Method
Increase or decrease in the size of GV, appearance of new esophageal varices and appearance or worsening of portal hypertensive gastropathy and complications.	Overall Study

Trial Locations

Locations (1)

G B Pant Hospital; 🇮🇳 New Delhi, Delhi, India