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Effectiveness of fibrin glue to prevent bleeding in high-risk patients after endoscopic submucosal dissection in gastric neoplasm : A prospective randomized controlled study

Status Approved

First Submitted Date

2021/02/22
Registered Date

2021/03/16
Last Updated Date

2024/01/24

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0006000
Unique Protocol ID	2004-093-1117
Public/Brief Title	Effectiveness of fibrin glue to prevent bleeding in high-risk patients after endoscopic submucosal dissection in gastric neoplasm : A prospective randomized controlled study
Scientific Title	Effectiveness of fibrin glue to prevent bleeding in high-risk patients after endoscopic submucosal dissection in gastric neoplasm : A prospective randomized controlled study
Acronym
MFDS Regulated Study	Yes
IND/IDE Protocol
Registered at Other Registry	Yes
Name of Registry / Registration Number	ClinicalTrials.gov-NCT04602689
Healthcare Benefit Approval Status	Submitted pending

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	H-2004-093-1117
Approval Date	2020-11-15
Institutional Review Board Name	Institutional Review Board, Seoul national university hospital
Institutional Review Board Address	103, Daehak-ro, Jongno-gu, Seoul
Institutional Review Board Telephone	02-2072-0694
Data Monitoring Committee	Yes Monitoring committee of Fibrin glue

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Soo jeong Cho
Title	Associate professor
Telephone	+82-2-2072-2228
Affiliation	Seoul National University Hospital
Address	Internal medicine, main bdg. 9th floor, Seoul national university hospital, Daehakro 101, Jongro-gu, Seoul, Republic of Korea
Contact Person for Public Queries
Name	Eunwoo Lee
Title	Fellow
Telephone	+82-2-2072-2228
Affiliation	Seoul National University Hospital
Address	Internal medicine, main bdg. 9th floor, Seoul national university hospital, Daehakro 101, Jongro-gu, Seoul, Republic of Korea
Contact Person for Updating Information
Name	Eunwoo Lee
Title	Fellow
Telephone	+82-2-2072-2228
Affiliation	Seoul National University Hospital
Address	Internal medicine, main bdg. 9th floor, Seoul national university hospital, Daehakro 101, Jongro-gu, Seoul, Republic of Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 3
Overall Recruitment Status	Completed
Date of First Enrollment	2020-11-16 Actual
Target Number of Participant	254
Primary Completion Date	2020-12-15 , Actual
Study Completion Date	2022-09-30 , Actual
Name of Study	Seoul National University Bundang Hospital
Recruitment Status	Completed
Date of First Enrollment	2020-11-16 ,
Recruitment Status by Participating Study Site 2
Name of Study	Yonsei University Health System, Severance Hospital
Recruitment Status	Completed
Date of First Enrollment	2020-11-16 ,
Recruitment Status by Participating Study Site 3
Name of Study	Asan Medical Center
Recruitment Status	Completed
Date of First Enrollment	2021-03-01 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Green Cross
Organization Type	Pharmaceutical Company
Project ID	H-2004-093-1117

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Seoul National University Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay 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.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Phase4
Intervention Model	Parallel
Blinding/Masking	Single
Blinded Subject	Subject
Allocation	RCT
Intervention Type	Drug
Intervention Description	Spread the Human fibrinogen concentrate/Aprotinin/Thrombin/Calcium chloride hydrate mixture on iatrogenic ulcer after ESD or not
Number of Arms	2
Arm 1	Arm Label Fibrin glue group
	Target Number of Participant 127
	Arm Type Experimental
	Arm Description Spread the Human fibrinogen concentrate/Aprotinin/Thrombin/Calcium chloride hydrate mixture on iatrogenic ulcer after ESD
Arm 2	Arm Label Control group
	Target Number of Participant 127
	Arm Type No intervention
	Arm Description No intervention after gastric ESD

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (C00-D48)Neoplasms (C16.99)Malignant neoplasm of stomach, unspecified, unspecified Early Gastric Cancer , Gastric adenoma
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~84Year
	Description 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
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Number of gastrointestinal bleeding events within 4 weeks after the procedure
Timepoint	4 weeks after the procedure
Secondary Outcome(s) 1
Outcome	Number of gastrointestinal bleeding events within 48 hours after the procedure
Timepoint	48 hours after the procedure
Secondary Outcome(s) 2
Outcome	Number of gastrointestinal bleeding events from 48 hours to 4 weeks after the procedure
Timepoint	48 hours to 4 weeks after the procedure

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	Yes Results Upload
Final Enrollment Number	254
Number of Publication	0
Results Upload	피브린글루 연구결과 국문 요약문.pdf
Date of Posting Results	2024/01/24
Protocol URL or File Upload	영문논문.pdf
Brief Summary	Baseline characteristics and treatment outcomes This trial was performed between July 1, 2020, and June 22, 2022. In total, 254 patients were randomized, and 247 patients were included in the modified intention-to-treat population (125 patients in the fibrin glue group and 122 patients in the control group) (Figure 3). Participants’ baseline characteristics are summarized in Table 1. The mean age was 67.7 years (range, 28–84 years). This trial included 185 (74.9%) men and 62 (25.1%) women. Thirty-six percentage (90/247) of patients took antithrombotic drugs, and 3.6% (9/247) were on dual antiplatelet therapy. Antithrombotics were continued in 7.3% (18/247) of enrolled patients. The 2 groups showed no significant differences in age, sex, comorbidities, antithrombotic medication, laboratory results, or endoscopic findings. Table 2 summarizes the histopathologic characteristics and procedural characteristics of the 2 groups. No significant betweengroup differences were found in histopathology, size of ESD specimen, tumor depth, procedure time, endoscopic clipping for hemostasis, preventive coagulation time, or rates of complete/curative resection. The mean time of applying fibrin glue to the iatrogenic ulcer was 1.5 minutes.

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Yes
Time of Sharing	2023. 5
Way of Sharing	Available on Request (rfsquid@naver.com)

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