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Fibrin Glue After ESD for High Risk Patients of Bleeding

Primary Purpose

Early Gastric Cancer, Gastric Adenoma

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Human fibrinogen concentrate
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Gastric Cancer

Eligibility Criteria

19 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Fibrin glue group

Control group

Arm Description

Spread Fibrin glue(Greenplast Q™) at iatrogenic ulcer after gastric ESD

No intervention after gastric ESD

Outcomes

Primary Outcome Measures

Bleeding after ESD
Number of gastrointestinal bleeding events within 4 weeks after the procedure

Secondary Outcome Measures

Early bleeding after ESD
Number of gastrointestinal bleeding events within 48 hours after the procedure
Delayed bleeding after ESD
Number of gastrointestinal bleeding events from 48 hours to 4 weeks after the procedure

Full Information

First Posted
October 20, 2020
Last Updated
February 22, 2021
Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital, Severance Hospital, Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04602689
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2020 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital, Severance Hospital, Asan Medical Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Gastric Cancer, Gastric Adenoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
254 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fibrin glue group
Arm Type
Experimental
Arm Description
Spread Fibrin glue(Greenplast Q™) at iatrogenic ulcer after gastric ESD
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention after gastric ESD
Intervention Type
Drug
Intervention Name(s)
Human fibrinogen concentrate
Intervention Description
Spread the Human fibrinogen concentrate/Aprotinin/Thrombin/Calcium chloride hydrate mixture on iatrogenic ulcer after ESD
Primary Outcome Measure Information:
Title
Bleeding after ESD
Description
Number of gastrointestinal bleeding events within 4 weeks after the procedure
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Early bleeding after ESD
Description
Number of gastrointestinal bleeding events within 48 hours after the procedure
Time Frame
48 hours
Title
Delayed bleeding after ESD
Description
Number of gastrointestinal bleeding events from 48 hours to 4 weeks after the procedure
Time Frame
from 48 hours to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eunwoo Lee, M.D.
Phone
82-10-9404-9109
Email
rfsquid@naver.com
First Name & Middle Initial & Last Name or Official Title & Degree
Soo-Jeong Cho, M.D., Ph.D.
Phone
82-10-5297-3398
Email
crystal522@daum.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eunwoo Lee, M.D.
Organizational Affiliation
fellowship
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eunwoo Lee, M.D.
Phone
82-10-9404-9109
Email
rfsquid@naver.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Fibrin Glue After ESD for High Risk Patients of Bleeding

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