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
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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WITHDRAWN
NA
INTERVENTIONAL
2019-04-30
Brief Summary
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1. Endoscopic Variceal Ligation with Non Selective Beta Blocker
2. Placebo with Endoscopic Variceal Ligation
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
Study Groups
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Endoscopic variceal ligation with Non-selective B-blockers
Endoscopic Variceal Ligation
Non selective beta blocker
Endoscopic variceal ligation with Placebo
Endoscopic Variceal Ligation
Placebo
Interventions
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Endoscopic Variceal Ligation
Non selective beta blocker
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
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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
Countries
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Other Identifiers
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ILBS-Cirrhosis-04
Identifier Type: -
Identifier Source: org_study_id
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