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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recurrence of variceal bleeding
Timeframe: 12 months
Trial details
NCT IDNCT02739581
SponsorInstitute of Liver and Biliary Sciences, India