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

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Cirrhosis

Treatments: Drug: Carvedilol+VSL#3; Procedure: Endoscopic variceal ligation

Study type: Interventional

Funder types: Other

Identifiers

NCT01196481

ILBS PHT-04

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Carvedilol+VSL#3

Experimental group

Description:

Tablet Carvedilol 6.25 mg BD + VSL#3

Treatment:

Drug: Carvedilol+VSL#3

Endoscopic Variceal Ligation

Active Comparator group

Description:

Endoscopic Variceal Ligation every 3-4 weeks till variceal ligation

Treatment:

Drug: Carvedilol+VSL#3

Procedure: Endoscopic variceal ligation