UnknownPhase 4

Preventing Recurrent Bleeding After Eradication of Esophageal Varices

Taiwan212 participantsStarted 2013-06

Plain-language summary

Esophageal variceal bleeding is a severe complication of portal hypertension. Banding ligation plus non-selective beta-blockers is the current recommendation for prevention of recurrent bleeding. However, the optimal duration of use of non-selective beta-blockers is not well defined. This study aims at comparing the rebleeding rate and adverse effects in patients using or without using propranolol after eradication of esophageal varices.

Who can participate

Age range

20 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: * Age of 20 to 80 years * Cirrhotic patients with acute or recent esophageal variceal bleeding proven by an endoscopy * Stable hemodynamic condition for at least 3 days after banding ligation Exclusion Criteria: * Hepatocellular carcinoma or other malignancy * Stroke or active sepsis * Chronic kidney disease under renal replacement therapy * Contraindications to non-selective beta-blockers * A history of non-selective beta-blockers use, sclerotherapy, banding ligation, transjugular intrahepatic porto-systemic shunt, or shunt surgery * Serum total bilirubin \>10 mg/dL * Grade III/IV hepatic encephalopathy * Refractory ascites * Hepato-renal syndrome * Pregnancy * Severe heart failure (NYHA Fc III/IV) * Bronchial asthma or chronic obstructive pulmonary disease * Second or third degree atrioventricular block * Sick sinus syndrome * Pacemaker use * Severe hypotension * Refusal to participate

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

recurrent esophageal variceal bleeding

Timeframe: 6 years

mortality or liver transplantation

Timeframe: 6 years

Trial details

NCT IDNCT02740166

SponsorKaohsiung Veterans General Hospital.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-01

Contact for this trial

Wen-Chi Chen, MD

886-7-3422121 wcchen@vghks.gov.tw

View on ClinicalTrials.gov More Esophageal Varices trials