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

Cirrhosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01196481
• Other study ID #: ILBS PHT-04
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: August 2015

Study information

• Verified date: December 2015
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis

Intervention

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.

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences (ILBS)	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of first variceal bleeding		1 Year
Secondary	Survival		1 Year
Secondary	Reduction in Portal pressure		1 Year
Secondary	Time to bleed		1 Years
Secondary	Adverse events		1 Year