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

Primary Purpose

Cirrhosis

Status

Unknown status

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Carvedilol

Endoscopic Variceal Ligation

About this trial

This is an interventional treatment trial for Cirrhosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Institute of liver and Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Carvedilol+EVL

Carvedilol

EVL

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall and bleed related Survival in all the 3 groups

Bleed related Survival in all the 3 groups

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

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

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

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

Incidence of Shock in all the 3 groups

Incidence of new ascites in all the 3 groups

HVPG response at 1year in all the 3 groups

Treatment related side effects in all the 3 groups

Full Information

NCT ID

NCT03069339

First Posted

February 28, 2017

Last Updated

February 18, 2020

Sponsor

Institute of Liver and Biliary Sciences, India

1. Study Identification

Unique Protocol Identification Number

NCT03069339

Brief Title

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

Official Title

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 Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Unknown status

Study Start Date

March 15, 2017 (Actual)

Primary Completion Date

November 30, 2020 (Anticipated)

Study Completion Date

November 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institute of Liver and Biliary Sciences, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cirrhosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

330 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Carvedilol+EVL

Arm Type

Experimental

Arm Title

Carvedilol

Arm Type

Experimental

Arm Title

EVL

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Carvedilol

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Endoscopic Variceal Ligation

Intervention Description

EVL will be done every 3 weeks till eradication

Primary Outcome Measure Information:

Title

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Overall and bleed related Survival in all the 3 groups

Time Frame

1 year

Title

Bleed related Survival in all the 3 groups

Time Frame

1 year

Title

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

Time Frame

1 year

Title

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

Time Frame

1 year

Title

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

Time Frame

1 year

Title

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

Time Frame

1 year

Title

Incidence of Shock in all the 3 groups

Time Frame

1 year

Title

Incidence of new ascites in all the 3 groups

Time Frame

1 year

Title

HVPG response at 1year in all the 3 groups

Time Frame

1 year

Title

Treatment related side effects in all the 3 groups

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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 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

Facility Information:

Facility Name

Institute of liver and Biliary Sciences

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110070

Country

India

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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