Fibrin Glue After ESD for High Risk Patients of Bleeding

Seoul National University

Status

Completed

Conditions

Early Gastric Cancer

Gastric Adenoma

Treatments

Drug: Human fibrinogen concentrate

Study type

Interventional

Funder types

Other

Identifiers

NCT04602689

2004-093-1117

Details and patient eligibility

About

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.

Full description

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.

Enrollment

134 patients

Sex

All

Ages

19 to 84 years old

Volunteers

No Healthy Volunteers

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