Clinical trial · Interventional
Endoscopic Closure of Gastric ESD Defect
Endoscopic Closure of Mucosal Defect After High-risk Gastric Endoscopic Submucosal Dissection (ESD) - a Pilot Study
- 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)
This is a pilot study to investigate the usefulness of closure of mucosal defect after gastric endoscopic submucosal dissection (ESD) in patients that are at high risk of post-procedural haemorrhage. Delayed haemorrhage is still an important adverse event of ESD, occurring more frequently for gastric lesions. Risk factors identified for delayed haemorrhage include chronic kidney disease, use of antithrombotic agent, lesion size \>20mm, specimen size \>30mm. Current established methods to prevent this complications could not completely eliminate the chance of bleeding, especially among high-risk cases. Closure of ESD defect may prevent ongoing exposure of submucosal vessels to gastric acid, and further reduce the risk of delayed haemorrhage. The investigators conduct this study to investigate the effect of closing the defect with endoscopic clips and loop. 30 patients who are undergoing gastric ESD deemed high risk of delayed haemorrhage would be recruited, with closure of defect after resection. The rate of delayed haemorrhage would be compared with historical cohort of patients.
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 |
|---|---|---|---|
| Gastric Cancer in Situ | — | UNRESOLVED | — |
| Gastric Dysplasia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic closure of ESD defect | Procedure | — | UNRESOLVED |
| Gastric ESD without closure of ESD defect | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Endoscopic closure
- description
- Prospectively collected patients for gastric ESD and would undergo closure of defect
- interventionNames
- Procedure: Endoscopic closure of ESD defect
- type
- OTHER
- label
- Historical control
- description
- Historical control of patients who underwent gastric ESD
- interventionNames
- Other: Gastric ESD without closure of ESD defect
Primary outcomes (1)
- measure
- Technical success rate
- timeFrame
- 1 day
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients undergoing elective gastric endoscopic submucosal dissection for epithelial lesions 2. Procedure deemed at high risk of post-procedural hemorrhage due to the following: 1. End stage renal disease (Estimated GFR \<15ml/min) 2. Patients on anti-thrombotic agents (Double antiplatelet, warfarin or direct oral anticoagulants) 3. Post ESD mucosal defect size \>4cm 3. Target subjects receiving sufficient briefing from the attending physician regarding the content of this study and providing informed consent for participation 4. Over 20 years of age Exclusion Criteria: 1. Recurrent / remnant lesion after previous endoscopic resection 2. Lesions arising from surgical anastomotic site, such as gastrojejunostomy / gastroduodenostomy. 3. Marked electrolyte abnormalities 4. Allergic to components of injection solutions: Epinephrine, hyaluronic acid etc 5. Other cases deemed by the examining physician as unsuitable for safe treatment 6. Patients who refused to participate
References
Publications (0)
Data not yet available