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

NACompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

December 31, 2012

Primary Completion Date

August 31, 2015

Study Completion Date

August 31, 2015

Conditions
Cirrhosis
Interventions
DRUG

Carvedilol+VSL#3

Tablet Carvedilol 6.25 mg BD \& capsule VSL#3 1 TDS for 2 year

PROCEDURE

Endoscopic variceal ligation

In the Endoscopic Variceal Ligation arm, Endoscopic Variceal Ligation will be performed using multibander devices by senior fully trained endoscopists or under their direct supervision. Varices will be banded starting at the gastroesophageal junction moving proximally upward in a spiral fashion. Patients will undergo Endoscopic Variceal Ligation every 3-4 weeks until eradication. Eradication is defined as the absence of varices or presence of grade I esophageal varices. Following eradication, the interval for the next endoscopy will be every 3 months to look for recurrence of varices. Endoscopic Variceal Ligation sessions would be repeated for the recurrent varices if they are sufficiently large.

Trial Locations (1)

110 070

Institute of Liver & Biliary Sciences (ILBS), New Delhi

All Listed Sponsors
lead

Institute of Liver and Biliary Sciences, India

OTHER

NCT01196481 - Carvedilol + VSL#3 Versus Endoscopic Variceal Ligation for Primary Prophylaxis of Esophageal Variceal Bleeding in Cirrhotic Patients Non Responder to Carvedilol. | Biotech Hunter | Biotech Hunter