Clinical trial · Interventional
Endoscopic Full Thickness Resection Versus Standard Therapy of the Colorectal Neoplasia
Endoscopic Full Thickness Resection Versus Standard Therapy of the Colorectal Neoplasia - Prospective Randomized 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)
Most of the cancers develop from the adenomatous polyps. The therapeutic methods have been established already - endoscopic polypectomy (EPE) for stalked polyps and endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for non-pedunculated polyps. EMR is preferred in European countries over ESD because of its higher feasibility. However, the local residual neoplasia (LRN) after EMR has been reported in 14 - 24 % cases. There is a higher LRN risk in sessile polyps which do not elevate sufficiently after the submucosal injection (non-lifting sign) and the piece-meal resection needs to be used. Therefore, the new method of endoscopic full-thickness resection (FTR) has been developed to resect these lesions.
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 |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Polyps | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EMR and ESD | Device | — | UNRESOLVED |
| Over- the- scope full- thickness resection device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- EMR/ESD
- description
- Standard EMR or ESD technique
- interventionNames
- Device: EMR and ESD
- type
- EXPERIMENTAL
- label
- Over- the- scope full- thickness resection device
- description
- Endoscopic full thickness resection
- interventionNames
- Device: Over- the- scope full- thickness resection device
Primary outcomes (1)
- measure
- Proportion of R0 procedures
- timeFrame
- 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age ≥ 18 years * colorectal lesions of 10-25 mm size with positive non-lifting sign * signed informed consent with the study and with colonoscopy Exclusion Criteria: * age \< 18 years * lesions \> 25 mm * pedunculated polyps * colorectal stenosis * colonoscopy contraindication * severe acute inflammatory bowel disease * severe comorbidities * patient not able to sign the informed consent
References
Publications (0)
Data not yet available