"Early TIPS" Versus Glue Obliteration to Prevent Rebleeding From Gastric Varices (NCT03705078) | Clinical Trial Compass
CompletedNot Applicable
"Early TIPS" Versus Glue Obliteration to Prevent Rebleeding From Gastric Varices
France104 participantsStarted 2019-01-03
Plain-language summary
The primary objective of the study is to demonstrate the superiority of an "early tips" strategy over standard treatment by glue obliteration (G0) in preventing bleeding recurrence or death at one year after a non GOV1 gastric variceal bleeding in cirrhotic patients initially treated by GO.
Who can participate
Age range
18 Years – 75 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:
* Cirrhotic patients: the diagnosis of liver cirrhosis will be based on previous needle liver biopsy or on the combination of clinical, biochemical, and radiological findings. If biopsy findings are unavailable and in case of non-complicated cirrhosis, non-invasive markers will be used.
* Variceal bleeding at endoscopy from gastroesophageal gastric varices type 2 or isolated gastric varices type 1 or 2 (Sarin classification) according to the following criteria: endoscopic signs of an active spurting or oozing from gastric varices (GV); adherent blood clots, white nipple signs, or erosions on the GV and absence of other bleeding sources.
* Hemodynamically stable patient (Mean arterial pressure above 65 mmHg) without clinical significant rebleeding (Baveno criteria) within 12 hours after the initial endoscopy with glue obliteration.
* Written informed consent obtained.
Exclusion Criteria:
* Pregnant woman or breastfeeding.
* Minor and patients older than 75 years.
* Non cirrhotic portal hypertension.
* Hepatocellular carcinoma outside the Milan criteria or other cancer at a palliative stage.
* Child Pugh score \> 13.
* History of severe or refractory hepatic encephalopathy unrelated to gastrointestinal bleeding.
* Congestive heart failure.
* History or presence of pulmonary hypertension.
* Patients with other indication for TIPS.
* Uncontrolled gastric variceal bleeding.
* Portal vein cavernoma.
* Patient who have previously received a TIPS procedure.
* F…
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
Incidence of clinically significant rebleeding (upper gastrointestinal bleeding whatever its origin)
Timeframe: 12 months
2
death
Timeframe: 12 months
Trial details
NCT IDNCT03705078
SponsorCentre Hospitalier Universitaire de Besancon