Primary Prophylaxis of Gastric Varix Bleed

Not Applicable

Completed

• Conditions: Cirrhosis
• Interventions: Procedure: Endoscopic cyanoacrylate injection; Drug: Beta-blocker (propranolol)

• Registration Number: NCT00905996
• Lead Sponsor: Govind Ballabh Pant Hospital

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.

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2009-05
• Study First Submitted: 2009-05-19
• Study First Submitted QC: 2009-05-20
• Last Update Submitted: 2009-05-20
• Study First Posted: 2009-05-21
• Last Update Posted: 2009-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endoscopic Cyanoacrylate injection	Endoscopic cyanoacrylate injection	Endoscopic injection of cyanoacrylate in the gastric varix until obturation
Beta-blocker (propranolol)	Beta-blocker (propranolol)	Beta-blocker (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
Bleeding from gastric varix or death	Within 2 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Shiv K Sarin; 🇮🇳 New Delhi, Delhi, India