Fibrin Glue After ESD for High Risk Patients of Bleeding

Study Overview
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Brief Summary
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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.

Detailed Description
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Investigators want to observe the bleeding rate after endoscopic submucosal dissection for gastric tumors in the high-risk group of bleeding (the size of the iatrogenic ulcer is expected to be 40mm or more, or taking aspirin, antiplatelet drugs, and anticoagulants). After resection and hemostasis with ESD, Fibrin glue (Greenplast Q™) is applied to the iatrogenic ulcer at the end of the procedure, and the control group will not be applied. After that, observe whether there is a difference in the bleeding rate within 48 hours and 4 weeks.

Official Title
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Effectiveness of Fibrin Glue to Prevent Bleeding in High-risk Patients After Endoscopic Submucosal Dissection in Gastric Neoplasm : A Prospective Randomized Controlled Study

Conditions
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Early Gastric Cancer, Gastric Adenoma

Intervention / Treatment
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* Drug: Human fibrinogen concentrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fibrin glue group<br>Spread Fibrin glue(Greenplast Q™) at iatrogenic ulcer after gastric ESD | Drug: Human fibrinogen concentrate<br>* Spread the Human fibrinogen concentrate/Aprotinin/Thrombin/Calcium chloride hydrate mixture on iatrogenic ulcer after ESD<br>|
| No Intervention: Control group<br>No intervention after gastric ESD | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding after ESD | Number of gastrointestinal bleeding events within 4 weeks after the procedure | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early bleeding after ESD | Number of gastrointestinal bleeding events within 48 hours after the procedure | 48 hours | 
| Delayed bleeding after ESD | Number of gastrointestinal bleeding events from 48 hours to 4 weeks after the procedure | from 48 hours to 4 weeks |