Clinical trial · Interventional
Full Thickness Resection or Endoscopic Submucosal Dissection for Difficult Colorectal Lesions.
Endoscopic Full Thickness Resection (EFTR) Versus Endoscopic Submucosal Dissection (ESD) in the Treatment of Difficult Colorectal Lesions With Dimensional Cut-off ≤ 30mm: Laterally Spreading Tumor Non Granular Type (LST-NG), "no Lift" Lesions and Residual / Relapses of Previous Resections. Endoscopic.
- 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)
Compare the efficacy and safety of endoscopic resection a full thickness (EFTR) with Full Thickness Resection Device (FTRD) System versus endoscopic submucosal dissection (ESD) in the treatment of Laterally Spreading Tumor Non Granular Type (LST-NG), "no lift" lesions colon and residual / relapse on scars from previous resections endoscopic colon. The dimensional cut off of these lesions is ≤30mm
Conditions
Conditions (1)
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 Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic Full-Thickness Resection (EFTR) | Procedure | — | UNRESOLVED |
| Endoscopic Submucosal Dissection (ESD) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Endoscopic Submucosal Dissection (ESD)
- description
- The Endoscopic Submucosal Dissection (ESD) procedures will be performed with the devices commonly used at the Services of Endoscopy of the Centers participating in the study. There are several models of knives on the market, produced by different companies, all considered equally effective by international guidelines.
- interventionNames
- Procedure: Endoscopic Submucosal Dissection (ESD)
- type
- EXPERIMENTAL
- label
- Endoscopic Full-Thickness Resection (EFTR)
- description
- The FTRD® (Full Thickness Resection Device; Ovesco Endoscopy, Tübingen, Germany) is the only over-the-scope device designed to undergo Endoscopic Full-Thickness Resection (EFTR) using a "clip-and-cut" technique. It consists of a 14 mm modified over-the-scope-clip (OTSC) mounted on the outside of a 23 mm cap, which has a preloaded 13 mm monofilament loop at the end. This device received the CE mark for the lower digestive tract in September 2014 and its efficacy and safety have been evaluated in preclinical studies and clinical trials.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * patients of age \>18 years * Laterally Spreading Tumor Non Granular Type (LST-NG) ≤ 3cm in diameter * "no-lift" colic injuries ≤ 3cm in diameter * residual / recurrence on the scar of previous endoscopic resections of the colon ≤ 3cm in diameter Exclusion criteria: * pregnant women * failure to accept or understand the consent to participate in the study * patients with severe coagulopathies * patients with short life expectancy (Charlson comorbidity index ≥8) * patients with expired general clinical conditions (American Society of Anesthesiologists score ≥3)
References
Publications (1)
- DERIVEDAndrisani G, Hassan C, Pizzicannella M, Pugliese F, Mutignani M, Campanale C, Valerii G, Barbera C, Antonelli G, Di Matteo FM. Endoscopic full-thickness resection versus endoscopic submucosal dissection for challenging colorectal lesions: a randomized trial. Gastrointest Endosc. 2023 Dec;98(6):987-997.e1. doi: 10.1016/j.gie.2023.06.009. Epub 2023 Jun 28. PMID 37390864