UnknownPhase 3

Balloon-occluded Retrograde Transvenous Obliteration for Gastric Variceal Rebleeding

Taiwan68 participantsStarted 2018-06-28

Plain-language summary

The goal of this randomized controlled trial is to compare the rebleeding rate in cirhotic patients with gastric variceal bleeding receiving balloon-occluded retrograde transvenous obliteration and endoscopic tissue glue injection. The main questions it aims to answer are: * Recurrent gastric variceal bleeding * Further decompensation of liver cirrhosis Participants will receive balloon-occluded retrograde transvenous obliteration and endoscopic tissue glue injection. Researchers will compare balloon-occluded retrograde transvenous obliteration and endoscopic tissue glue injection to see if the rebleeding rate associated with balloon-occluded retrograde transvenous obliteration is lower than that associated with endoscopic tissue glue injection.

Who can participate

Age range

20 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 more than 20 years * a history of liver cirrhosis * acute GOV2 or IGV1 bleeding Exclusion Criteria: * previous treatment for gastric varices, including endoscopic therapy, transjugular intrahepatic portosystemic shunt, or shunt surgery * hepatocellular carcinoma or other malignancy * stroke, uremia, or active sepsis * serum total bilirubin \>10 mg/dL * grade III/IV hepatic encephalopathy * refractory ascites * uncontrolled index bleeding * pregnancy * severe heart failure (NYHA Fc III/IV) * allergy to cyanoacrylate, lipiodol, iodine, or sodium tetradecyl sulfate * absence of gastrorenal shunt

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 gastric variceal bleeding

Timeframe: From date of randomization until the date of first documented recurrent gastric variceal bleeding or date of death from any cause, whichever comes first, assessed up to 100 months

further liver decompensation

Timeframe: From date of randomization until the date of first documented further liver decompensation or date of death from any cause, whichever comes first, assessed up to 100 months

Trial details

NCT IDNCT06106971

SponsorKaohsiung Veterans General Hospital.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06

Contact for this trial

Wen-Chi Chen, M.D

+886 (07) 3468016 wcchen@vghks.gov.tw

View on ClinicalTrials.gov More Gastric Varices Bleeding trials