Efficacy and Safety of Endoscopic Variceal Ligation (EVL) Versus EVL Plus Non-selective B-blockers (NSBB) For Prevention of Variceal Rebleed and Non-bleed Related Complications in Patients With Advanced Cirrhosis

October 8, 2019 updated by: Institute of Liver and Biliary Sciences, India

The patients will be randomized into two groups

  1. Endoscopic Variceal Ligation with Non Selective Beta Blocker
  2. Placebo with Endoscopic Variceal Ligation

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients between 18 and 80 years old.
  • Clinical criteria and/or analytical, ultrasound and/or liver biopsy consistent with the diagnosis of liver cirrhosis.
  • Endoscopic Diagnosis of esophageal variceal bleeding within 5 days prior to study inclusion.
  • Written informed consent to participate in the study.
  • Child C status, CTP >10

Exclusion Criteria:

  • Pregnancy or lactation
  • Serum Creatinine > 2 mg/dl
  • Bleeding due to gastric varices.
  • Active infection or recent infection < 2 weeks
  • Presence of hepatocellular carcinoma or portal vein thrombosis
  • Active alcoholism
  • Pregnancy
  • HIV infection
  • Severe heart, respiratory or contraindications for beta blockers(severe chronic obstructive pulmonary disease, severe asthma, severe insulin-dependent diabetes mellitus, Brady arrhythmia)
  • Not giving consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endoscopic variceal ligation with Non-selective B-blockers
Procedure: Endoscopic Variceal Ligation
Drug: Non selective beta blocker
Active Comparator: Endoscopic variceal ligation with Placebo
Other: Placebo
Procedure: Endoscopic Variceal Ligation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence of variceal bleeding
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: 24 months
24 months
Survival
Time Frame: 12 months
12 months
Recurrence of variceal bleeding
Time Frame: 24 months
24 months
Bleeding severity in both arms
Time Frame: 12 months
12 months
Bleeding severity in both arms
Time Frame: 24 months
24 months
Incidence or progression of Portal Hypertension complications such as ascites control in both arms.
Time Frame: 12 months
12 months
Incidence or progression of Portal Hypertension complications such as Spontaneous Bacterial Peritonitis in both arms.
Time Frame: 12 months
12 months
Incidence or progression of Portal Hypertension complications such as Hepatorenal syndrome in both arms.
Time Frame: 12 months
12 months
Appearance or progression of Portal Vein Thrombosis in both arms
Time Frame: 12 months
12 months
Number of patients receive alternative treatments transhepatic intrajugular portosystemic shunt in both arms.
Time Frame: 12 months
12 months
Incidence of adverse events in both groups
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Liver and Biliary Sciences, India

Investigators

  • Principal Investigator: Dr Ankur Jindal, MD, Institute of liver and Biliary Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Anticipated)

April 1, 2019

Study Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

April 12, 2016

First Submitted That Met QC Criteria

April 12, 2016

First Posted (Estimate)

April 15, 2016

Study Record Updates

Last Update Posted (Actual)

October 10, 2019

Last Update Submitted That Met QC Criteria

October 8, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILBS-Cirrhosis-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Advanced Cirrhosis

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe