Fibrin Glue After ESD for High Risk Patients of Bleeding
NCT ID: NCT04602689
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
134 participants
INTERVENTIONAL
2020-10-30
2022-07-14
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Fibrin glue group
Spread Fibrin glue(Greenplast Q™) at iatrogenic ulcer after gastric ESD
Human fibrinogen concentrate
Spread the Human fibrinogen concentrate/Aprotinin/Thrombin/Calcium chloride hydrate mixture on iatrogenic ulcer after ESD
Control group
No intervention after gastric ESD
No interventions assigned to this group
Interventions
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Human fibrinogen concentrate
Spread the Human fibrinogen concentrate/Aprotinin/Thrombin/Calcium chloride hydrate mixture on iatrogenic ulcer after ESD
Eligibility Criteria
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Inclusion Criteria
* 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 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
19 Years
84 Years
ALL
No
Sponsors
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Seoul National University Bundang Hospital
OTHER
Severance Hospital
OTHER
Asan Medical Center
OTHER
Seoul National University Hospital
OTHER
Responsible Party
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Soo-Jeong Cho
Clinical associate professor
Principal Investigators
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Eunwoo Lee, M.D.
Role: STUDY_DIRECTOR
fellowship
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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References
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Lee HD, Lee E, Kim SG, Shin CM, Park JC, Choi KD, Hahn S, Cho SJ. A Randomized Controlled Trial of Fibrin Glue to Prevent Bleeding After Gastric Endoscopic Submucosal Dissection. Am J Gastroenterol. 2023 May 1;118(5):892-899. doi: 10.14309/ajg.0000000000002172. Epub 2022 Dec 30.
Other Identifiers
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2004-093-1117
Identifier Type: -
Identifier Source: org_study_id