Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding (NCT05746884) | Clinical Trial Compass
RecruitingNot Applicable
Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding
France234 participantsStarted 2023-08-21
Plain-language summary
The purpose of this study is to test whether prophylactic application of haemostatic gel will reduce the rate of clinically significant bleeding requiring intervention (such as blood transfusion, admission to hospital, other blood products) following endoscopic resection of advanced duodenal neoplasia compared to standard therapy.
Who can participate
Age range
18 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:
Ampullary lesions
* Single ampullary lesion ≥ 10mm
* Resection via hot ampullectomy, injection/Endoscopic mucosal resection of adjacent lateral spreading component Duodenal Lesions
* ≤ 2 lesions
* Lesion ≥15mm
* Resection via hot Endoscopic mucosal resection
* Morphology: 0-Is, 0-IIa/b/c or combination, submucosal lesions
Exclusion Criteria:
* Inability to provide informed consent (including people with cognitive impairment);
* Pregnant or breastfeeding women;
* Allergy to PuraStat®;
* "Cold" mucosal endoscopic resection;
* Patient under guardianship or curatorship, or under a regime of deprivation of liberty;
* Participating patient, or in a period of exclusion from another clinical trial;
* Patient not benefiting from a social security scheme.
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
Bleeding rate requiring further intervention within 30 days
Timeframe: 30 days
Trial details
NCT IDNCT05746884
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche