NCT03069339
Unknown
Not Applicable
Carvedilol, Endoscopic Variceal Ligation or Combination of Both for Prevention of First Variceal Bleed in Child's B & C Cirrhosis: A Randomized Controlled Trial
Institute of Liver and Biliary Sciences, India1 site in 1 country330 target enrollmentMarch 15, 2017
Overview
- Phase
- Not Applicable
- Intervention
- Carvedilol
- Conditions
- Cirrhosis
- Sponsor
- Institute of Liver and Biliary Sciences, India
- Enrollment
- 330
- Locations
- 1
- Primary Endpoint
- Reduction in the incidence of first variceal bleed at 1 year.
- Last Updated
- 6 years ago
Overview
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
Investigators
Eligibility Criteria
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
- •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
Arms & Interventions
Carvedilol+EVL
Intervention: Carvedilol
Carvedilol+EVL
Intervention: Endoscopic Variceal Ligation
Carvedilol
Intervention: Carvedilol
EVL
Intervention: Endoscopic Variceal Ligation
Outcomes
Primary Outcomes
Reduction in the incidence of first variceal bleed at 1 year.
Time Frame: 1 year
Secondary Outcomes
- 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)
Study Sites (1)
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