Early Primary Prophylaxis of Esophageal Varices

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients of cirrhosis with portal hypertension aged 18 to 75 years who have small esophageal varices with or without red color signs and have not bled previously will be enrolled. After baseline evaluation, the participants will be randomized to receive either Placebo or Carvedilol 12.5 mg BD. After randomization they will be followed up for one year. The primary endpoint of the study is the the proportions of patients who develop large varices (Gd 3 or Gd 4) at 1 year in each group. The secondary endpoint are survival,reduction in HVPG,change in CTP and MELD score& adverse events.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India
• Treatments: Carvedilol

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Any contra-indication to beta-blockers

• Any EVL or sclerotherapy within last 3 months

• Child Turcotte Pugh (CTP) score > 12, refractory ascites, hepatorenal syndrome

• Any past history of surgery for portal hypertension

• Significant cardio or pulmonary co-morbidity

• Any malignancy that affects survival.

• Active alcohol abuse or last intake ≤ 4 weeks to avoid possibility of ongoing alcohol hepatitis.

• Past history of surgery for portal hypertension

• Uncontrolled diabetes

• Peripheral vascular disease

• Refusal to participate in the study