Fibrin Glue After ESD for High Risk Patients of Bleeding

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborators: Asan Medical Center; Seoul National University Bundang Hospital; Severance Hospital

Criteria

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