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

NCT01196481 | Completed

• 1 other identifier: ILBS PHT-04
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Development of first variceal bleeding

  1 Year

Secondary Outcomes (4)

• Survival

  1 Year

• Reduction in Portal pressure

  1 Year

• Time to bleed

  1 Years

• Adverse events

  1 Year

Study Arms (2)

Carvedilol+VSL#3

EXPERIMENTAL

Tablet Carvedilol 6.25 mg BD + VSL#3

Drug: Carvedilol+VSL#3

Endoscopic Variceal Ligation

ACTIVE COMPARATOR

Endoscopic Variceal Ligation every 3-4 weeks till variceal ligation

Drug: Carvedilol+VSL#3; Procedure: Endoscopic variceal ligation

Interventions

Carvedilol+VSL#3 DRUG

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

Carvedilol+VSL#3; Endoscopic Variceal Ligation

Endoscopic variceal ligation 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.

Endoscopic Variceal Ligation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, 110 070, India

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shiv Kumar Sarin, MBBS, MD, DM

  Institute of Liver & Biliary Sciences (ILBS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2010
• First Posted: September 8, 2010
• Study Start: December 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 15, 2020

Record last verified: 2015-12

Locations

IN (1)