Early Gastric Cancer Clinical Trial
Official title:
Effectiveness of Fibrin Glue to Prevent Bleeding in High-risk Patients After Endoscopic Submucosal Dissection in Gastric Neoplasm : A Prospective Randomized Controlled Study
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.
Status | Recruiting |
Enrollment | 254 |
Est. completion date | October 1, 2022 |
Est. primary completion date | October 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 84 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | Asan Medical Center, Seoul National University Bundang Hospital, Severance Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bleeding after ESD | Number of gastrointestinal bleeding events within 4 weeks after the procedure | 4 weeks | |
Secondary | Early bleeding after ESD | Number of gastrointestinal bleeding events within 48 hours after the procedure | 48 hours | |
Secondary | Delayed bleeding after ESD | Number of gastrointestinal bleeding events from 48 hours to 4 weeks after the procedure | from 48 hours to 4 weeks |
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