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, India330 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

330

Conditions

Cirrhosis

Interventions

CarvedilolDRUG

Carvedilol will start at starting dose of 3.125 mg BD followed by 6.25 mg BD followed by 12.5 mg BD if BP 90/60 mmHg and HR 55/min

Endoscopic Variceal LigationPROCEDURE

EVL will be done every 3 weeks till eradication

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Outcomes

Primary Outcomes

Reduction in the incidence of first variceal bleed at 1 year.

Time frame: 1 year

Secondary Outcomes

Overall and bleed related Survival in all the 3 groups

Time frame: 1 year

Bleed related Survival in all the 3 groups

Time frame: 1 year

Improvement in Child-Turcotte-Pugh (CTP) score in all the 3 groups

Time frame: 1 year

Improvement in Model for End Stage Liver Disease (MELD) score in all the 3 groups

Time frame: 1 year

Incidence of Spontaneous Bacterial Peritonitis (SBP) in all the 3 groups

Time frame: 1 year

Incidence of Acute Kidney Injury (AKI) in all the 3 groups

Time frame: 1 year

Incidence of Shock in all the 3 groups

Time frame: 1 year

Incidence of new ascites in all the 3 groups

Time frame: 1 year

HVPG response at 1year in all the 3 groups

Time frame: 1 year

Treatment related side effects in all the 3 groups

Time frame: 1 year

Data from ClinicalTrials.gov

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