Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
65 participants
OBSERVATIONAL
2018-05-01
2020-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Endoscopic full-thickness resection
Patients with neoplastic lesions less than 30mm unresectable en bloc by other less invasive endoscopic techniques, including lesions suggestive of T1 colorectal cancer, subepithelial tumors, lesions with diverticular involvement, lesions with no-lifting sign (recurrent, incomplete prior resection or untreated lesions).
Endoscopic full-thickness resection
Endoscopic full-thickness resection (EFTR) with Over-The-Scope-Clip in colorectal lesions
Interventions
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Endoscopic full-thickness resection
Endoscopic full-thickness resection (EFTR) with Over-The-Scope-Clip in colorectal lesions
Eligibility Criteria
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Inclusion Criteria
* Colonic lesions less than 30mm unresectable en-bloc by other less invasive endoscopic techniques, including lesions suggestive of T1, subepithelial tumors, lesions with diverticular involvement, lesions with no-lifting signs (recurrent, incomplete prior resection or untreated).
* Patients who give their written informed consent for the procedure and for the study.
Exclusion Criteria
* Neoplastic lesions of the colon with evidence of advanced stage (for example, lymph node involvement) or more than 3 cm in greatest diameter.
* Any medical, psychological, geographical, or social problem that is significant and uncontrolled that may interfere with the patient's participation in the study or that does not allow adequate follow-up and adherence to the protocol and evaluation of the results of the study.
18 Years
ALL
No
Sponsors
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Spanish Society of Digestive Endoscopy
OTHER
Hospital de Sant Joan Despí Moisès Broggi
OTHER
Complejo Hospitalario de Navarra
OTHER
Hospital Clínico Universitario de Santiago de Compostela
UNKNOWN
Hospital Provincial de Castellon
OTHER
Althaia Xarxa Assistencial Universitària de Manresa
OTHER
Hospital Mutua de Terrassa
OTHER
Hospital General Universitario Gregorio Marañon
OTHER
Hospital San Carlos, Madrid
OTHER
Hospital Universitario 12 de Octubre
OTHER
Hospital General de Ciudad Real
OTHER
Hospital General Universitario Elche
OTHER
Hospital Universitario Central de Asturias
OTHER
Hospital Clinic of Barcelona
OTHER
Quironsalud
OTHER
Hospital Universitario La Paz
OTHER
Centro Medico Teknon
OTHER
Germans Trias i Pujol Hospital
OTHER
Fundació Institut Germans Trias i Pujol
OTHER
Responsible Party
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HugoUchima
Medical Specialist (gastroenterologist, MD)
Principal Investigators
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Hugo I. Uchima Koecklin, MD
Role: PRINCIPAL_INVESTIGATOR
Medical researcher
Locations
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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
Castellon, Castellón, Spain
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, La Coruña, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, 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
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
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References
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Schmidt A, Meier B, Caca K. Endoscopic full-thickness resection: Current status. World J Gastroenterol. 2015 Aug 21;21(31):9273-85. doi: 10.3748/wjg.v21.i31.9273.
Uchima H, Barquero D, Fernandez A, Mata A, Huertas C, Figa M, Hombrados M, Espinos JC. Su1638 Early Discharge After Endoscopic Full-Thickness Resection in the Colorectum. Gastrointest Endosc. 2017;85:5, AB375
Schmidt A, Beyna T, Schumacher B, Meining A, Richter-Schrag HJ, Messmann H, Neuhaus H, Albers D, Birk M, Thimme R, Probst A, Faehndrich M, Frieling T, Goetz M, Riecken B, Caca K. Colonoscopic full-thickness resection using an over-the-scope device: a prospective multicentre study in various indications. Gut. 2018 Jul;67(7):1280-1289. doi: 10.1136/gutjnl-2016-313677. Epub 2017 Aug 10.
Backes Y, Kappelle WFW, Berk L, Koch AD, Groen JN, de Vos Tot Nederveen Cappel WH, Schwartz MP, Kerkhof M, Siersema PD, Schroder R, Tan TG, Lacle MM, Vleggaar FP, Moons LMG; T1 CRC Working Group. Colorectal endoscopic full-thickness resection using a novel, flat-base over-the-scope clip: a prospective study. Endoscopy. 2017 Nov;49(11):1092-1097. doi: 10.1055/s-0043-114730. Epub 2017 Jul 28.
Other Identifiers
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HU-EMPRET
Identifier Type: -
Identifier Source: org_study_id
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