Clinical trial NCT04602689: Fibrin Glue After ESD for High Risk Patients of Bleeding
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Gastric Cancer
Gastric Adenoma
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
name: Severance Hospital
name: Asan Medical Center
First posted: 2020-10-26
Enrollment: 134
Sex: ALL
Minimum age (years): 19
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Bleeding after ESD
timeFrame: 4 weeks
Secondary outcomes:
measure: Early bleeding after ESD
timeFrame: 48 hours
measure: Delayed bleeding after ESD
timeFrame: from 48 hours to 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: fellowship
name: Eunwoo Lee, M.D.
role: STUDY_DIRECTOR
References: