Clinical trial · Interventional
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
NCT04602689CI-TRIAL-00083129completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Gastric Cancer | Early Gastric Carcinoma | ALIAS | 0.90 |
| Gastric Adenoma | Gastric Adenoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Human fibrinogen concentrate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fibrin glue group
- description
- Spread Fibrin glue(Greenplast Q™) at iatrogenic ulcer after gastric ESD
- interventionNames
- Drug: Human fibrinogen concentrate
- type
- NO_INTERVENTION
- label
- Control group
- description
- No intervention after gastric ESD
Primary outcomes (1)
- measure
- Bleeding after ESD
- timeFrame
- 4 weeks
- description
- Number of gastrointestinal bleeding events within 4 weeks after the procedure
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 84 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLee 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 36594814