Early Primary Prophylaxis of Esophageal Varices

Institute of Liver and Biliary Sciences, India

Status

Completed

Conditions

Cirrhosis

Treatments

Drug: Placebo

Drug: Carvedilol

Study type

Interventional

Funder types

Other

Identifiers

NCT01196507

ILBS PHT-02

Details and patient eligibility

About

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.

Enrollment

140 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 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