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

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

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 Overview

• Status: Unknown
• Conditions: Cirrhosis
• Intervention / Treatment: Drug: Carvedilol; Procedure: Endoscopic Variceal Ligation

• Study Type: Interventional
• Enrollment (Actual): 330
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver and Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carvedilol	Drug: Carvedilol; 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
Experimental: Carvedilol+EVL	Drug: Carvedilol; 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; Procedure: Endoscopic Variceal Ligation; EVL will be done every 3 weeks till eradication
Active Comparator: EVL	Procedure: Endoscopic Variceal Ligation; EVL will be done every 3 weeks till eradication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction in the incidence of first variceal bleed at 1 year.	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall and bleed related Survival in all the 3 groups	1 year
Bleed related Survival in all the 3 groups	1 year
Improvement in Child-Turcotte-Pugh (CTP) score in all the 3 groups	1 year
Improvement in Model for End Stage Liver Disease (MELD) score in all the 3 groups	1 year
Incidence of Spontaneous Bacterial Peritonitis (SBP) in all the 3 groups	1 year
Incidence of Acute Kidney Injury (AKI) in all the 3 groups	1 year
Incidence of Shock in all the 3 groups	1 year
Incidence of new ascites in all the 3 groups	1 year
HVPG response at 1year in all the 3 groups	1 year
Treatment related side effects in all the 3 groups	1 year

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2017
• Primary Completion (Anticipated): November 30, 2020
• Study Completion (Anticipated): November 30, 2020

Study Registration Dates

• First Submitted: February 28, 2017
• First Submitted That Met QC Criteria: March 1, 2017
• First Posted (Actual): March 3, 2017

Study Record Updates

• Last Update Posted (Actual): February 19, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Protective Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Antioxidants; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Carvedilol
• Other Study ID Numbers: ILBS-Cirrhosis-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No