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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04602689
Other study ID # 2004-093-1117
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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