Carvedilol (drug), Endoscopic Variceal Ligation (procedure) or combination of both for prevention of First Bleed in liver disease

Not Applicable

• Conditions: Health Condition 1: null- CirrhosisHealth Condition 2: K746- Other and unspecified cirrhosis ofliver

• Registration Number: CTRI/2017/07/008996
• Lead Sponsor: Institute of liver and Biliary Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 330

Inclusion Criteria

1) Liver Cirrhotics between 18 to 70 years of age (cirrhosis diagnosed on the basis of clinical, biochemical, fibroscan and imaging.)

2) CTP more than equals to 7 to 15.

3) Small esophageal varices with RCS and large esophageal varices (more than 5 mm)

4) No history of previous bleed

Exclusion Criteria

1) Malignancy-HCC, PVT

2) Child A

3) MELD >35

4) Contraindications to β blockers.

5) Platelet count < 30,000/mm3

6)Previous endoscopic variceal treatment. (Beyond 21 days)

7) Patients having an indication for TIPS or requiring more than 1 therapeutic ascitic tapping/month

8) Post TIPS, Shunt surgery

9)Acute kidney injury (Sr.Cr >1.5mg/dl)

10) Non cirrhotic portal hypertension

11) Acute on chronic liver failure

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in the incidence of first variceal bleed at 1 yearTimepoint: 1 year

Secondary Outcome Measures

Name	Time	Method
Bleed related Survival in all the 3 groupsTimepoint: 1 year;HVPG response at 1year in all the 3 groupsTimepoint: 1 year;HVPG response at 2 year in all the 3 groupsTimepoint: 2 year;HVPG response in all the 3 groupsTimepoint: 3 months;Improvement in Child-Turcotte-Pugh (CTP) score in all the 3 groupsTimepoint: 1 year;Improvement in Model for End Stage Liver Disease (MELD) score in all the 3 groupsTimepoint: 1 year;Incidence of Acute Kidney Injury (AKI) in all the 3 groupsTimepoint: 1 year;Incidence of new ascites in all the 3 groupsTimepoint: 1 year;Incidence of Shock in all the 3 groupsTimepoint: 1 year;Incidence of Spontaneous Bacterial Peritonitis (SBP) in all the 3 groups <br/ ><br>Timepoint: 1 year;Overall Survival in all the 3 groupsTimepoint: 1 year;Treatment related side effects in all the 3 groupsTimepoint: 1 year