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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 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: April 19, 2014
Last verified: December 2013

September 4, 2010
April 19, 2014
December 2012
December 2014   (final data collection date for primary outcome measure)
Development of first variceal bleeding [ Time Frame: 2 year ] [ Designated as safety issue: No ]
Development of first variceal bleeding [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01196481 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Requirement of liver transplantation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Time to bleed [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Development or worsening of complications of cirrhosis (ascites, encephalopathy, HRS, SBP etc) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Carvedilol + VSL#3 Versus Endoscopic Variceal Ligation for Primary Prophylaxis of Esophageal Variceal Bleeding in Cirrhosis.
A Prospective,Open Labeled, Randomized Controlled Trial Comparing Carvedilol + VSL# 3 Versus Endoscopic Variceal Ligation for Primary Prophylaxis of Esophageal Variceal Bleeding in Cirrhosis.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Cirrhosis
  • 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.
  • Experimental: Carvedilol+VSL#3
    Tablet Carvedilol 6.25 mg BD + VSL#3
    Intervention: Drug: Carvedilol+VSL#3
  • Active Comparator: Endoscopic Variceal Ligation
    Endoscopic Variceal Ligation every 3-4 weeks till variceal ligation
    Interventions:
    • Drug: Carvedilol+VSL#3
    • Procedure: Endoscopic variceal ligation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
146
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Shiv Kumar Sarin, MD,DM +91-9873173140 shivsarin@gmail.com
Contact: Ankit Bhardwaj +91-9717270640 bhardwaj.ankit3@gmail.com
India
 
NCT01196481
ILBS PHT-04
No
Institute of Liver and Biliary Sciences, India
Institute of Liver and Biliary Sciences, India
Not Provided
Principal Investigator: Shiv Kumar Sarin, MBBS, MD, DM Institute of Liver & Biliary Sciences (ILBS)
Institute of Liver and Biliary Sciences, India
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP