Clinical trial · Interventional
Complete Closure After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps
Complete Closure After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps: A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 9, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260909-000002
Summary
Brief summary (as posted)
The goal of this clinical trial is to compare adverse even rates after EMR for large (≥20mm) flat colorectal polyps (so-called laterally spreading lesions, LSLs) when performing complete or no defect closure. It will also evaluate lesion recurrence after EMR for large colorectal LSLs. The hypothesis is that performing complete defect closure following EMR of large colorectal LSLs will result in lower rates of adverse events compared to cases where no defect closure is performed. For participants with planned EMR, endoscopists will perform EMRs as per standard of care and: * prophylactic defect closure will either not be performed (control group), or will be performed (experimental group); * then, patients will be called between 14 and 44 days after EMR to assess for possible adverse events, and electronic medical files will be verified for emergency room visits and healthcare received for an adverse event; * finally, patients will undergo follow-up colonoscopy 6 months and 18 months after randomization.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Polyp of Colon | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No prophylactic defect closure | Procedure | — | UNRESOLVED |
| Prophylactic defect closure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Endoscopic Mucosal Resection (EMR) + prophylactic defect closure (defect closure)
- description
- Prophylactic defect closure will be performed using at least one new generation closure device.
- type
- ACTIVE_COMPARATOR
- label
- Endoscopic Mucosal Resection (EMR)
- description
- After performing EMR with thermal ablation, prophylactic defect closure will not be performed.
- interventionNames
- Procedure: No prophylactic defect closure
Primary outcomes (2)
- measure
- Delayed bleeding
- timeFrame
- 14 days
- description
- Defined as blood per rectum resulting in emergency room visit, unplanned hospitalization; endoscopic, radiologic, or surgical intervention.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * adult ≥18 years old * patients undergoing EMR for a large (≥20mm) colorectal LSL * patients providing written and informed consent for study participation. Exclusion Criteria: * inflammatory bowel disease; * non-elective colonoscopy; * poor general health (American Society of Anesthesiologists classification \>III); * coagulopathy or thrombocytopenia (international normalized ratio ≥1.5 or platelets \<50 x 109/L); * pedunculated polyps (Paris class Ip, Isp); * overt signs of deep submucosal invasive cancer (JNET 3); * appendiceal orifice or terminal ileum invasion; * pregnancy.
References
Publications (0)
Data not yet available