Efficacy and Safety of Endoscopic Variceal Ligation (EVL) Versus EVL Plus Non-selective B-blocker… (NCT02739581) | Clinical Trial Compass
WithdrawnNot Applicable
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
Stopped: Lack of funds
India0
Plain-language summary
The patients will be randomized into two groups
1. Endoscopic Variceal Ligation with Non Selective Beta Blocker
2. Placebo with Endoscopic Variceal Ligation
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Recurrence of variceal bleeding
Timeframe: 12 months
Trial details
NCT IDNCT02739581
SponsorInstitute of Liver and Biliary Sciences, India