Clinical trial · Interventional
Reducing Neoplasia Recurrence After Non-thermal Endoscopic Resection of Large Colorectal Polyps
- 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)
The goal of this clinical trial is to clarify the role of adjuvant thermal ablation for non-thermal endoscopic mucosal resection (EMR) of large (≥20mm) flat colorectal polyps (so-called laterally spreading lesions \[LSLs\]). The hypothesis is that adding adjuvant thermal ablation to non-thermal EMR (vs no ablation) will result in lower lesion recurrence rates at 6-month follow-up, and non-inferior adverse events (AE) rates 14 days post EMR. For participants with planned EMR, endoscopists will perform non-thermal EMRs as per standard of care and: * adjuvant thermal ablation will either not be performed (control group), or will be applied to the base and outside margins of the resection site (experimental group); * then, all patients will be contacted 14-44 days after EMR, to verbally ascertain the occurrence of AEs; * then, all patients will undergo a first follow-up colonoscopy at 6 months after initial conoloscopy to assess lesion recurrence; * finally, all patients will undergo a second and final colonoscopy 18 months after EMR.
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 |
|---|---|---|---|
| Adjuvant thermal ablation | Procedure | — | UNRESOLVED |
| No adjuvant thermal ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Endoscopic mucosal resection (EMR) + adjuvant thermal ablation
- description
- Adjuvant thermal ablation will be applied to the base and outside margins of the resection site after non-thermal EMR.
- interventionNames
- Procedure: Adjuvant thermal ablation
- type
- ACTIVE_COMPARATOR
- label
- Endoscopic mucosal resection (EMR)
- description
- After non-thermal EMR, no adjuvant thermal ablation will be performed.
- interventionNames
- Procedure: No adjuvant thermal ablation
Primary outcomes (2)
- measure
- Lesion recurrence rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients * Undergoing EMR for large (≥20 mm) colorectal LSL * 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 ration ≥1.5 or platelets \<50\*10\^9/L) * Bulky lesions (granular mixed with ≥10mm module).
References
Publications (0)
Data not yet available