Early Gastric CancerNCT04602689
Fibrin Glue After ESD for High Risk Patients of Bleeding
A study testing Human fibrinogen concentrate in people with Early Gastric Cancer and Gastric Adenoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 84 years
- Conditions the study is for
- Early Gastric Cancer, Gastric Adenoma
- What is being tested?
- Human fibrinogen concentrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Oct 2020to 14 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Early Gastric Cancer, Gastric Adenoma
- Being tested
- Human fibrinogen concentrate
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human fibrinogen concentrateDrug
Spread the Human fibrinogen concentrate/Aprotinin/Thrombin/Calcium chloride hydrate mixture on iatrogenic ulcer after ESD
| Study group | Role | What they receive |
|---|---|---|
| Fibrin glue group | Experimental | Spread Fibrin glue(Greenplast Q™) at iatrogenic ulcer after gastric ESD Receives: Drug: Human fibrinogen concentrate |
| Control group | No intervention | No intervention after gastric ESD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding after ESD
Number of gastrointestinal bleeding events within 4 weeks after the procedure
Measured: 4 weeks
Secondary outcomes (2)
Early bleeding after ESD
Number of gastrointestinal bleeding events within 48 hours after the procedure
Measured: 48 hours
Delayed bleeding after ESD
Number of gastrointestinal bleeding events from 48 hours to 4 weeks after the procedure
Measured: from 48 hours to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start30 Oct 2020
- Primary completion14 Jul 2022
- Study completion14 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Gastric CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Severance Hospital, Asan Medical Center
- Responsible party
- Principal investigator, Soo-Jeong Cho, Seoul National University Hospital
- Investigators
- Eunwoo Lee, M.D., Study director, fellowship
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602689
- Sponsor's protocol ID
- 2004-093-1117
- Status last verified
- Nov 2024
- First submitted
- 20 Oct 2020
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36594814
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04602689
- Acronym / sponsor ID
- 2004-093-1117
- Conditions
- Early Gastric Cancer, Gastric Adenoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Severance Hospital, Asan Medical Center
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 14 Jul 2022 (actual)
- Study completion
- 14 Jul 2022 (actual)
- First posted
- 26 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibrin glue group | Experimental | Drug: Human fibrinogen concentrateSpread Fibrin glue(Greenplast Q™) at iatrogenic ulcer after gastric ESD |
| Control group | No intervention | –No intervention after gastric ESD |
Who may qualify
- Ages
- 19 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human fibrinogen concentrateSpread the Human fibrinogen concentrate/Aprotinin/Thrombin/Calcium chloride hydrate mixture on iatrogenic ulcer after ESD | Drug | Fibrin glue group |
Primary outcome
Bleeding after ESD
Time frame: 4 weeks
Number of gastrointestinal bleeding events within 4 weeks after the procedure
2 secondary outcomes
Early bleeding after ESD
Time frame: 48 hours
Delayed bleeding after ESD
Time frame: from 48 hours to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Derived from this study: PubMed 36594814Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eunwoo Lee, M.D. study director
fellowship
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human fibrinogen concentrate in people with Early Gastric Cancer and Gastric Adenoma, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding after ESD (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04602689, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.