NCT04602689

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 26, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

October 30, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2022

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

1.7 years

First QC Date

October 20, 2020

Last Update Submit

November 26, 2024

Conditions

Early Gastric CancerGastric Adenoma

Outcome Measures

Primary Outcomes (1)

  • Bleeding after ESD

    Number of gastrointestinal bleeding events within 4 weeks after the procedure

    4 weeks

Secondary Outcomes (2)

  • Early bleeding after ESD

    48 hours

  • Delayed bleeding after ESD

    from 48 hours to 4 weeks

Study Arms (2)

Fibrin glue group

EXPERIMENTAL

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

Drug: Human fibrinogen concentrate

Control group

NO INTERVENTION

No intervention after gastric ESD

Interventions

Human fibrinogen concentrateDRUG

Spread the Human fibrinogen concentrate/Aprotinin/Thrombin/Calcium chloride hydrate mixture on iatrogenic ulcer after ESD

Fibrin glue group

Eligibility Criteria

Age19 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

  • Lee HD, Lee E, Kim SG, Shin CM, Park JC, Choi KD, Hahn S, Cho SJ. A Randomized Controlled Trial of Fibrin Glue to Prevent Bleeding After Gastric Endoscopic Submucosal Dissection. Am J Gastroenterol. 2023 May 1;118(5):892-899. doi: 10.14309/ajg.0000000000002172. Epub 2022 Dec 30.

    PMID: 36594814DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Eunwoo Lee, M.D.

    fellowship

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical associate professor

Study Record Dates

First Submitted

October 20, 2020

First Posted

October 26, 2020

Study Start

October 30, 2020

Primary Completion

July 14, 2022

Study Completion

July 14, 2022

Last Updated

November 29, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)