Fibrin Glue After ESD for High Risk Patients of Bleeding

Early Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04602689
• Other study ID #: 2004-093-1117
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: February 2021
• Source: Seoul National University Hospital
• Contact: Eunwoo Lee, M.D.
• Phone: 82-10-9404-9109
• Email: rfsquid[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 254
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Early Gastric Cancer
• Gastric Adenoma

Intervention

Drug:
• Human fibrinogen concentrate
Spread the Human fibrinogen concentrate/Aprotinin/Thrombin/Calcium chloride hydrate mixture on iatrogenic ulcer after ESD

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
Seoul National University Hospital	Asan Medical Center, Seoul National University Bundang Hospital, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding after ESD	Number of gastrointestinal bleeding events within 4 weeks after the procedure	4 weeks
Secondary	Early bleeding after ESD	Number of gastrointestinal bleeding events within 48 hours after the procedure	48 hours
Secondary	Delayed bleeding after ESD	Number of gastrointestinal bleeding events from 48 hours to 4 weeks after the procedure	from 48 hours to 4 weeks