Fibrin Glue After ESD for High Risk Patients of Bleeding (NCT04602689) | Clinical Trial Compass
CompletedNot Applicable
Fibrin Glue After ESD for High Risk Patients of Bleeding
South Korea134 participantsStarted 2020-10-30
Plain-language summary
It is a prospective randomized controlled study to look for effectiveness of fibrin glue to prevent bleeding in high-risk patients after endoscopic submucosal dissection in gastric neoplasm.
Who can participate
Age range
19 Years – 84 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:
* ECOG performance status 0-1
* Patients scheduled to undergo ESD due to gastric tumor (dysplasia, early gastric cancer)
* Patients who are expected to have an iatrogenic ulcer size of 40mm or more after endoscopic submucosal dissection, or are taking aspirin, antiplatelet drugs, or anticoagulants
* Patients who show adequate patient compliance and have adequate geographic distance for follow-up observation.
Exclusion Criteria:
* Patients with sensitivity to cow protein or its derived ingredients
* Patients who had previously undergone partial gastrectomy
* Patients with early gastric cancer at the site previously undergoing ESD
* Patients with clinically significant cardiopulmonary disease
* Patients with active hepatitis, liver disease that is not well controlled by treatment, or severe liver disorder
* Patients with severe renal impairment
* Patients with severe bone marrow dysfunction
* Patients with severe blood clotting impairment (including hemophilia)
* Patients with serious neurological or mental illness (e.g. epilepsy or dementia)
* Patients with reported side effects of contrast media
* Pregnant and lactating women
* Patients who have not obtained the informed consent of the patient and guardian
* Patients who are inadequate for clinical trials as judged by the attending physician
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.