Carvedilol, Endoscopic Variceal Ligation or Combination of Both for Prevention of First Variceal Bleed in Child's B & C Cirrhosis

Institute of Liver and Biliary Sciences, India

Status: Unknown

Conditions: Cirrhosis

Treatments: Procedure: Endoscopic Variceal Ligation; Drug: Carvedilol

Study type: Interventional

Funder types: Other

Identifiers

NCT03069339

ILBS-Cirrhosis-07

Details and patient eligibility

About

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

Enrollment: 330 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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330 participants in 3 patient groups

Carvedilol+EVL

Experimental group

Treatment:

Procedure: Endoscopic Variceal Ligation

Drug: Carvedilol

Carvedilol

Experimental group

Treatment:

Drug: Carvedilol

EVL

Active Comparator group

Treatment:

Procedure: Endoscopic Variceal Ligation