NCT04602689

Fibrin Glue After ESD for High Risk Patients of Bleeding

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 84 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Early Gastric Cancer
• Gastric Adenoma

Interventions

Type	Name	Description
DRUG	Human fibrinogen concentrate	Spread the Human fibrinogen concentrate/Aprotinin/Thrombin/Calcium chloride hydrate mixture on iatrogenic ulcer after ESD

Timeline

• Start date: 2020-10-30
• Primary completion: 2022-07-14
• Completion: 2022-07-14
• First posted: 2020-10-26
• Last updated: 2024-11-29

Locations

1 site across 1 country: South Korea