Full Thickness Resection or Endoscopic Submucosal Dissection for Difficult Colorectal Lesions.

Study Overview
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Brief Summary
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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

Official Title
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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.

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Procedure: Endoscopic Full-Thickness Resection (EFTR)
* Procedure: Endoscopic Submucosal Dissection (ESD)


Participation Criteria
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Eligibility Criteria
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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)

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 |
| --- | --- |
| Active Comparator: Endoscopic Submucosal Dissection (ESD)<br>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. | Procedure: Endoscopic Submucosal Dissection (ESD)<br>* Standard Endoscopic Submucosal Dissection using standard procedure described in international guidelines.<br>|
| Experimental: Endoscopic Full-Thickness Resection (EFTR)<br>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. | Procedure: Endoscopic Full-Thickness Resection (EFTR)<br>* Full Thickness Endoscopic Resection using the FTRD Ovesco Device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| En-bloc resection rate | the rate of one-piece resection of the lesions | 1 year | 
| R0 resection rate | percentage of patients with histologically negative lateral and deep margins | 1 year |