Carvedilol + VSL#3 Versus Endoscopic Variceal Ligation for Primary Prophylaxis of Esophageal Variceal Bleeding in Cirrhotic Patients Non Responder to Carvedilol.

Not Applicable

Completed

• Conditions: Cirrhosis
• Interventions: Drug: Carvedilol+VSL#3; Procedure: Endoscopic variceal ligation

• Registration Number: NCT01196481
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief Summary

Patients of cirrhosis will be enrolled who have large esophageal varices, which have never bled. After successful screening baseline hepatic venous pressure gradient (HVPG) will be measured. Tablet carvedilol 3.125 mg BD for 1 week will be started. It will be increased to 6.25 mg BD and continued for next 7 weeks. After completion of 8 weeks the hepatic venous pressure gradient (HVPG) will again be measured to find out responders (hepatic venous pressure gradient ≥20% reduction from baseline or absolute value of hepatic venous pressure gradient \<12 mm Hg) and non responders (hepatic venous pressure gradient \<20% reduction).The responders will be excluded from the study while the non responders will be randomize into carvedilol+VSL#3 versus Endoscopic Variceal Ligation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-04
• Study First Submitted QC: 2010-09-07
• Study First Posted: 2010-09-08
• Study Start: 2012-12
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-12
• Last Update Submitted: 2020-05-14
• Last Update Posted: 2020-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients of cirrhosis with portal hypertension aged 18 to 75 years who have large esophageal varices with or without red color signs and have not bled previously.

Exclusion Criteria

• Any contra-indication to beta-blockers
• Coagulopathy with INR >1.8 at the time of enrollment
• Any Endoscopic Variceal Ligation or sclerotherapy within last 3 months
• Any past history of surgery for portal hypertension
• Significant cardio or pulmonary co-morbidity
• Any malignancy
• Refusal to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carvedilol+VSL#3	Carvedilol+VSL#3	Tablet Carvedilol 6.25 mg BD + VSL#3
Endoscopic Variceal Ligation	Carvedilol+VSL#3	Endoscopic Variceal Ligation every 3-4 weeks till variceal ligation
Endoscopic Variceal Ligation	Endoscopic variceal ligation	Endoscopic Variceal Ligation every 3-4 weeks till variceal ligation

Primary Outcome Measures

Name	Time	Method
Development of first variceal bleeding	1 Year

Secondary Outcome Measures

Name	Time	Method
Survival	1 Year
Reduction in Portal pressure	1 Year
Time to bleed	1 Years
Adverse events	1 Year

Trial Locations

Locations (1)

Institute of Liver & Biliary Sciences (ILBS); 🇮🇳 New Delhi, Delhi, India