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

NCT ID: NCT01196481

Last Updated: 2020-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-08-31

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.

Conditions

Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Carvedilol+VSL#3

Tablet Carvedilol 6.25 mg BD + VSL#3

Group Type: EXPERIMENTAL

Carvedilol+VSL#3

Intervention Type: DRUG

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

Endoscopic Variceal Ligation

Endoscopic Variceal Ligation every 3-4 weeks till variceal ligation

Group Type: ACTIVE_COMPARATOR

Carvedilol+VSL#3

Intervention Type: DRUG

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

Endoscopic variceal ligation

Intervention Type: PROCEDURE

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.

Interventions

Carvedilol+VSL#3

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

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shiv Kumar Sarin, MBBS, MD, DM

Role: PRINCIPAL_INVESTIGATOR

Institute of Liver & Biliary Sciences (ILBS)

Locations

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, India

Countries

India

Other Identifiers

ILBS PHT-04

Identifier Type: -

Identifier Source: org_study_id