Fibrin Glue After ESD for High Risk Patients of Bleeding

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

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.

Study Overview

• Status: Unknown
• Conditions: Early Gastric Cancer; Gastric Adenoma
• Intervention / Treatment: Drug: Human fibrinogen concentrate

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.

• Study Type: Interventional
• Enrollment (Anticipated): 254
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eunwoo Lee, M.D.; Phone Number: 82-10-9404-9109; Email: rfsquid@naver.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Eunwoo Lee, M.D.; Phone Number: 82-10-9404-9109; Email: rfsquid@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 84 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fibrin glue group; Spread Fibrin glue(Greenplast Q™) at iatrogenic ulcer after gastric ESD	Drug: Human fibrinogen concentrate; Spread the Human fibrinogen concentrate/Aprotinin/Thrombin/Calcium chloride hydrate mixture on iatrogenic ulcer after ESD
NO_INTERVENTION: Control group; No intervention after gastric ESD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding after ESD	Number of gastrointestinal bleeding events within 4 weeks after the procedure	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early bleeding after ESD	Number of gastrointestinal bleeding events within 48 hours after the procedure	48 hours
Delayed bleeding after ESD	Number of gastrointestinal bleeding events from 48 hours to 4 weeks after the procedure	from 48 hours to 4 weeks

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Asan Medical Center; Seoul National University Bundang Hospital; Severance Hospital
• Investigators: Study Director: Eunwoo Lee, M.D., Fellowship

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 30, 2020
• Primary Completion (ANTICIPATED): October 1, 2022
• Study Completion (ANTICIPATED): October 1, 2022

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (ACTUAL): October 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 25, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: 2004-093-1117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No