Endoscopic full-thickness resection (EFTR) in the colon using an over-the-scope clip (OTSC) as a closure mechanism is a recent technique that allows the endoscopic resection of colonic lesions that are poor candidates for conventional endoscopic resection techniques. The aim is to study the safety and efficacy of EFTR in colon.
Early detection and endoscopic resection of early neoplastic lesions in colon can prevent the development of colon cancer. The classic endoscopic mucosal resection technique and the submucosal dissection technique require the creation of a submucosal "cushion" by injecting crystalloid substances or colloids. However, these advanced techniques have technical limitations when facing a lesion that presents poor lifting or non-lifting at all as it might be observed in scarring or fibrotic lesions Endoscopic full-thickness resection (EFTR) in the colon using an over-the-scope clip (OTSC) is a recent technique that does not require the injection of a submucosal solution and allows a resection of colonic lesions of up to approximately 30 mm, en bloc, allowing a correct histological study of the sample, to confirm its complete resection with adequate deep margins, evaluation of the level of invasion and lymphovascular involvement. EFTR with OTSC allows a colonic wall full-thickness resection, by the deployment of an over-the-scope clip before the resection of the lesion to prevent perforation. The steps of the technique are: face the lesion and marking the borders, insertion of the scope with the kit (consisting of a cap with an integrated snare and OTSC), grasping and pulling the lesion into the cap, deploy the over-the-scope-clip (OTSC) and closing the integrated snare and resect. This is a multicenter observational study on the efficacy and safety of EFTR with OTSC in colon. The clinical, endoscopic and histological data are collected prospectively in all cases of EFTR performed in the participant centers.
Study Type
OBSERVATIONAL
Enrollment
65
Endoscopic full-thickness resection (EFTR) with Over-The-Scope-Clip in colorectal lesions
Hospital General Universitario de Elche
Elche, Alicante, Spain
RECRUITINGFundació Althaia, Xarxa Assistencial Universitària de Manresa
Manresa, Barcelona, Spain
RECRUITINGHospital de Sant Joan Despí Moisès Broggi
Sant Joan Despí, Barcelona, Spain
RECRUITINGHospital de Sant Joan Despí Moisès Broggi
Sant Joan Despí, Barcelona, Spain
RECRUITINGHospital de Sant Joan Despí Moisès Broggi
Sant Joan Despí, Barcelona, Spain
RECRUITINGHospital Universitari Mútua de Terrassa
Terrassa, Barcelona, Spain
RECRUITINGConsorcio Hospitalario Provincial de Castellón
Castellon, Castellón, Spain
RECRUITINGHospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, La Coruña, Spain
RECRUITINGComplejo Hospitalario de Navarra
Pamplona, Navarre, Spain
RECRUITINGHospital Clínic de Barcelona
Barcelona, Spain
RECRUITING...and 7 more locations
Technical Success
Percentage of complete en-bloc resection of the lesion without macroscopic residual tissue after completing the endoscopic full-thickness resection
Time frame: Through study completion, an average of 1 year
Major adverse events
Percentage of procedure-associated major adverse events: bleeding and/or perforation
Time frame: 3 months
Histologically confirmed full-thickness resection
Histologically confirmed full-thickness resection
Time frame: 30 days
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