The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Endoscopic Full-Thickness Resection In Colon
Official Title: Multicenter Prospective Study of Endoscopic Full-thickness Resection (EFTR) in Colon Using Over-the-scope-clip (OTSC)
Study ID: NCT03803891
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hospital General Universitario de Elche, Elche, Alicante, Spain
Fundació Althaia, Xarxa Assistencial Universitària de Manresa, Manresa, Barcelona, Spain
Hospital de Sant Joan Despí Moisès Broggi, Sant Joan Despí, Barcelona, Spain
Hospital de Sant Joan Despí Moisès Broggi, Sant Joan Despí, Barcelona, Spain
Hospital de Sant Joan Despí Moisès Broggi, Sant Joan Despí, Barcelona, Spain
Hospital Universitari Mútua de Terrassa, Terrassa, Barcelona, Spain
Consorcio Hospitalario Provincial de Castellón, Castelló de la Plana, Castellón, Spain
Hospital Clínico Universitario de Santiago de Compostela, Santiago De Compostela, La Coruña, Spain
Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain
Hospital Clínic de Barcelona, Barcelona, , Spain
Hospital General Universitario de Ciudad Real, Ciudad Real, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Hospital Clínico San Carlos, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Quirónsalud Málaga, Málaga, , Spain
Hospital Universitario Central de Asturias, Oviedo, , Spain
Name: Hugo I. Uchima Koecklin, MD
Affiliation: Medical researcher
Role: PRINCIPAL_INVESTIGATOR