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

NCT ID: NCT02739581

Last Updated: 2019-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Completion Date

2019-04-30

Brief Summary

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The patients will be randomized into two groups

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

Detailed Description

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Conditions

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Advanced Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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Endoscopic variceal ligation with Non-selective B-blockers

Group Type EXPERIMENTAL

Endoscopic Variceal Ligation

Intervention Type PROCEDURE

Non selective beta blocker

Intervention Type DRUG

Endoscopic variceal ligation with Placebo

Group Type ACTIVE_COMPARATOR

Endoscopic Variceal Ligation

Intervention Type PROCEDURE

Placebo

Intervention Type OTHER

Interventions

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Endoscopic Variceal Ligation

Intervention Type PROCEDURE

Non selective beta blocker

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Ankur Jindal, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Liver and Biliary Sciences

Locations

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Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

Other Identifiers

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ILBS-Cirrhosis-04

Identifier Type: -

Identifier Source: org_study_id

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