Phase
Condition
Stomach Cancer
Gastric Cancer
Treatment
Human fibrinogen concentrate
Clinical Study ID
Ages 19-84 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
ECOG performance status 0-1
Patients scheduled to undergo ESD due to gastric tumor (dysplasia, early gastriccancer)
Patients who are expected to have an iatrogenic ulcer size of 40mm or more afterendoscopic submucosal dissection, or are taking aspirin, antiplatelet drugs, oranticoagulants
Patients who show adequate patient compliance and have adequate geographic distancefor follow-up observation.
Exclusion
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 bytreatment, 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
Study Description
Connect with a study center
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
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