Carvedilol, Endoscopic Variceal Ligation or Combination of Both for Prevention of First Variceal Bleed in Child's B & C Cirrhosis
Not Applicable
- Conditions
- Cirrhosis
- Interventions
- Procedure: Endoscopic Variceal Ligation
- Registration Number
- NCT03069339
- Lead Sponsor
- Institute of Liver and Biliary Sciences, India
- Brief Summary
Study Design: Open labeled randomized controlled trial. The study will be conducted on patients attending outpatient or admitted to admitted to Department of Hepatology from January 2017 to December 2018 at ILBS, New Delhi
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 330
Inclusion Criteria
- Liver Cirrhotics between 18-70 yrs of age (cirrhosis diagnosed on the basis of clinical, biochemical, fibroscan & imaging.)
- CTP ≥ 7-15 (Child's B/C)
- Small esophageal varices with RCS and large esophageal varices (>5 mm)
- No history of previous bleed
Exclusion Criteria
- Malignancy-HCC, PVT
- Child A
- MELD >35
- Contraindications to β blockers.
- Platelet count < 30,000/mm3
- Previous endoscopic variceal treatment. (Beyond 21 days)
- Patients having an indication for TIPS or requiring more than 1 therapeutic ascitic tapping/month
- Post TIPS, Shunt surgery
- Acute kidney injury (Sr.Cr>1.5mg/dl)
- Non cirrhotic portal hypertension
- Acute on chronic liver failure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Carvedilol+EVL Endoscopic Variceal Ligation - Carvedilol Carvedilol - EVL Endoscopic Variceal Ligation - Carvedilol+EVL Carvedilol -
- Primary Outcome Measures
Name Time Method Reduction in the incidence of first variceal bleed at 1 year. 1 year
- Secondary Outcome Measures
Name Time Method Improvement in Model for End Stage Liver Disease (MELD) score in all the 3 groups 1 year Incidence of Acute Kidney Injury (AKI) in all the 3 groups 1 year Improvement in Child-Turcotte-Pugh (CTP) score in all the 3 groups 1 year Bleed related Survival in all the 3 groups 1 year HVPG response at 1year in all the 3 groups 1 year Incidence of Shock in all the 3 groups 1 year Treatment related side effects in all the 3 groups 1 year Overall and bleed related Survival in all the 3 groups 1 year Incidence of Spontaneous Bacterial Peritonitis (SBP) in all the 3 groups 1 year Incidence of new ascites in all the 3 groups 1 year
Trial Locations
- Locations (1)
Institute of liver and Biliary Sciences
🇮🇳New Delhi, Delhi, India