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Carvedilol + VSL#3 Versus Endoscopic Variceal Ligation for Primary Prophylaxis of Esophageal Variceal Bleeding in Cirrhosis. (Large_Vx)

This study is currently recruiting participants.
Verified March 2013 by Institute of Liver and Biliary Sciences, India
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier:
NCT01196481
First received: September 4, 2010
Last updated: March 25, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention
Cirrhosis
 Drug: Carvedilol+VSL#3
Procedure: Endoscopic variceal ligation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Cirrhosis.

Resource links provided by NLM:

Drug Information available for: Carvedilol
U.S. FDA Resources

Further study details as provided by Institute of Liver and Biliary Sciences, India:

Primary Outcome Measures:
  • Development of first variceal bleeding [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival [ Time Frame: 2 year ] [ Designated as safety issue: No ]
  • Requirement of liver transplantation [ Time Frame: 2 year ] [ Designated as safety issue: No ]
  • Time to bleed [ Time Frame: 2 year ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
  • Development or worsening of complications of cirrhosis (ascites, encephalopathy, Hepato Renal Syndrome, Spontaneous Bacterial Peritonitis etc) [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 146
Study Start Date: November 2011
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01196481

Contacts
Contact: Shiv Kumar Sarin, MD,DM +91-9873173140 shivsarin@gmail.com
Contact: Ankit Bhardwaj +91-9717270640 bhardwaj.ankit3@gmail.com

Locations
India
Institute of Liver & Biliary Sciences (ILBS) Recruiting
New Delhi, Delhi, India, 110 070
Contact: Shiv Kumar Sarin, MD,DM     011-46300000     shivsarin@gmail.com    
Contact: Ankit Bhardwaj     +91-9717270640        
Principal Investigator: Shiv Kumar Sarin, MBBS, MD, DM            
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)
  More Information

No publications provided

Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT01196481     History of Changes
Other Study ID Numbers: ILBS PHT-04
Study First Received: September 4, 2010
Last Updated: March 25, 2013
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Hemorrhage
Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on May 19, 2013