Clinical trial · Interventional
Endoscopic Full-thickness REsection of Residual Colorectal Lesions - The FiRE 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)
Adenomatous lesions of the colon are premalignant lesions which have the potential to develop cancer. Therefore adenomas should be resected endoscopically (endo- mucosa resection, EMR). EMR is conducted after submucosal injection of saline which allows to lift the desired lesion prior to resection. In some cases EMR is complicated due to incomplete or failed lifting after the injection of saline. This so- called "non- lifting" sign is a predictor for malignancy of the lesion. Difficult- to- lift polyps are also difficult- to- resect. A higher proportion of these lesions fail to be resected completely using the EMR technique. Alternatively, an over- the- scope full- thickness resection device (FTRD) can be used in order to resect colonic lesions. The FTRD technique has been described elsewhere (Schmidt et al. Gastroenterology 2014; 147: 740-742.e2). No comparative data exists until now on the performance of FTRD resection compared to standard EMR resection of difficult- to- resect colon adenomas. In this study the investigators aim to compare the success of FTRD versus EMR of difficult- to- resect adenomatous lesions (≤ 20 mm).
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 |
|---|---|---|---|
| Adenoma | Adenoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EMR | Device | — | UNRESOLVED |
| over- the- scope full- thickness resection device (FTRD) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- EMR
- description
- Standard EMR technique
- interventionNames
- Device: EMR
- type
- EXPERIMENTAL
- label
- FTRD
- interventionNames
- Device: over- the- scope full- thickness resection device (FTRD)
Primary outcomes (1)
- measure
- Success of resection
- timeFrame
- 3 month
- description
- Success of resection: Complete resection (R0) according to clinical and/or histopathological assessment
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* patients ≥ 18 years
* adenomatous lesion 10-20 mm in size with expected difficulties regarding EMR (e.g. "non- lifting sign")
Exclusion Criteria:
* patients \< 18 years
* lesions \> 20 mm in size
* high risk carcinomas ("deep submucosal carcinoma")
* American Society of Anesthesiologists (ASA) class IV and higherReferences
Publications (0)
Data not yet available