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 range19 Years – 84 Years
SexALL
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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