Seoul National University Hospital
Seoul, 03080, South Korea
NCT Number: NCT04602689
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.
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Notify Me19 year–84 year
All sexes
Interventional
Not applicable
Seoul, 03080, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Spread the Human fibrinogen concentrate/Aprotinin/Thrombin/Calcium chloride hydrate mixture on iatrogenic ulcer after ESD
Time frame: 4 weeks
Number of gastrointestinal bleeding events within 4 weeks after the procedure
Time frame: 48 hours
Number of gastrointestinal bleeding events within 48 hours after the procedure
Time frame: from 48 hours to 4 weeks
Number of gastrointestinal bleeding events from 48 hours to 4 weeks after the procedure
Seoul National University Hospital
Other
Effectiveness of Fibrin Glue to Prevent Bleeding in High-risk Patients After Endoscopic Submucosal Dissection in Gastric Neoplasm : A Prospective Randomized Controlled Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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