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

Sponsor

Institute of Liver and Biliary Sciences, India (Other)

Overall Status

Completed

CT.gov ID

NCT01196481

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis	Drug: Carvedilol+VSL#3 Procedure: Endoscopic variceal ligation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A Prospective,Open Labeled, Randomized Controlled Trial Comparing Carvedilol + VSL# 3 Versus Endoscopic Variceal Ligation for Primary Prophylaxis of Esophageal Variceal Bleeding in Cirrhotic Patients Non Responder to Carvedilol.

Study Start Date :

Dec 1, 2012

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Carvedilol+VSL#3 Tablet Carvedilol 6.25 mg BD + VSL#3	Drug: Carvedilol+VSL#3 Tablet Carvedilol 6.25 mg BD & capsule VSL#3 1 TDS for 2 year
Active Comparator: Endoscopic Variceal Ligation Endoscopic Variceal Ligation every 3-4 weeks till variceal ligation	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.

Arm

Intervention/Treatment

Experimental: Carvedilol+VSL#3

Tablet Carvedilol 6.25 mg BD + VSL#3

Drug: Carvedilol+VSL#3

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

Active Comparator: Endoscopic Variceal Ligation

Endoscopic Variceal Ligation every 3-4 weeks till variceal ligation

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.

Outcome Measures

Primary Outcome Measures

Development of first variceal bleeding [1 Year]

Secondary Outcome Measures

Survival [1 Year]
Reduction in Portal pressure [1 Year]
Time to bleed [1 Years]
Adverse events [1 Year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Liver & Biliary Sciences (ILBS)	New Delhi	Delhi	India	110 070

Sponsors and Collaborators

Institute of Liver and Biliary Sciences, India

Investigators

Principal Investigator: Shiv Kumar Sarin, MBBS, MD, DM, Institute of Liver & Biliary Sciences (ILBS)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institute of Liver and Biliary Sciences, India

ClinicalTrials.gov Identifier:

NCT01196481

Other Study ID Numbers:

ILBS PHT-04

First Posted:

Sep 8, 2010

Last Update Posted:

May 15, 2020

Last Verified:

Dec 1, 2015

Additional relevant MeSH terms:

Fibrosis

Carvedilol

Study Results

No Results Posted as of May 15, 2020