Endoscopic Full-thickness REsection of Residual Colorectal Lesions - The FiRE Study

Study Overview
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Brief Summary
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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
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Adenoma

Intervention / Treatment
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* Device: over- the- scope full- thickness resection device (FTRD)
* Device: EMR


Participation Criteria
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Eligibility Criteria
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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 higher

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EMR<br>Standard EMR technique | Device: EMR<br>* Standard endoscopic mucosal resection using a resection snare<br>|
| Experimental: FTRD<br> | Device: over- the- scope full- thickness resection device (FTRD)<br>* Endoscopic resection of adenomatous lesions of the colon using the over- the- scope full- thickness resection device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of resection | Success of resection: Complete resection (R0) according to clinical and/or histopathological assessment | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of procedure |  | up to 1 day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenoma, EMR, FTRD, non- lifting, colon