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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
134
Spread the Human fibrinogen concentrate/Aprotinin/Thrombin/Calcium chloride hydrate mixture on iatrogenic ulcer after ESD
Seoul National University Hospital
Seoul, South Korea
Bleeding after ESD
Number of gastrointestinal bleeding events within 4 weeks after the procedure
Time frame: 4 weeks
Early bleeding after ESD
Number of gastrointestinal bleeding events within 48 hours after the procedure
Time frame: 48 hours
Delayed bleeding after ESD
Number of gastrointestinal bleeding events from 48 hours to 4 weeks after the procedure
Time frame: from 48 hours to 4 weeks
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