Colorectal Cancer Clinical Trial
— EFTRICOMOfficial title:
Multicenter Prospective Study of Endoscopic Full-thickness Resection (EFTR) in Colon Using Over-the-scope-clip (OTSC)
NCT number | NCT03803891 |
Other study ID # | HU-EMPRET |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2018 |
Est. completion date | July 31, 2020 |
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.
Status | Recruiting |
Enrollment | 65 |
Est. completion date | July 31, 2020 |
Est. primary completion date | January 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adults (=18 years) of both sexes. - 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: - Refusal to grant informed consent. - 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clínic de Barcelona | Barcelona | |
Spain | Consorcio Hospitalario Provincial de Castellón | Castelló de la Plana | Castellón |
Spain | Hospital General Universitario de Ciudad Real | Ciudad Real | |
Spain | Hospital General Universitario de Elche | Elche | Alicante |
Spain | Hospital Clínico San Carlos | Madrid | |
Spain | Hospital General Universitario Gregorio Marañón | Madrid | |
Spain | Hospital Universitario 12 de Octubre | Madrid | |
Spain | Hospital Universitario La Paz | Madrid | |
Spain | Hospital Quirónsalud Málaga | Málaga | |
Spain | Fundació Althaia, Xarxa Assistencial Universitària de Manresa | Manresa | Barcelona |
Spain | Hospital Universitario Central de Asturias | Oviedo | |
Spain | Complejo Hospitalario de Navarra | Pamplona | Navarra |
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 Clínico Universitario de Santiago de Compostela | Santiago De Compostela | La Coruña |
Spain | Hospital Universitari Mútua de Terrassa | Terrassa | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Fundació Institut Germans Trias i Pujol | Althaia Xarxa Assistencial Universitària de Manresa, Centro Medico Teknon, Complejo Hospitalario de Navarra, Germans Trias i Pujol Hospital, Hospital Clinic of Barcelona, Hospital Clínico San Carlos, Hospital Clínico Universitario de Santiago de Compostela, Hospital de Sant Joan Despí Moisès Broggi, Hospital General de Ciudad Real, Hospital General Universitario Elche, Hospital General Universitario Gregorio Marañon, Hospital Mutua de Terrassa, Hospital Provincial de Castellon, Hospital Quirónsalud Málaga, Hospital Universitario 12 de Octubre, Hospital Universitario Central de Asturias, Hospital Universitario La Paz, Sociedad Española de Endoscopia Digestiva |
Spain,
Backes Y, Kappelle WFW, Berk L, Koch AD, Groen JN, de Vos Tot Nederveen Cappel WH, Schwartz MP, Kerkhof M, Siersema PD, Schröder 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. — View Citation
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. — View Citation
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. Review. — View Citation
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Technical Success | Percentage of complete en-bloc resection of the lesion without macroscopic residual tissue after completing the endoscopic full-thickness resection | Through study completion, an average of 1 year | |
Secondary | Major adverse events | Percentage of procedure-associated major adverse events: bleeding and/or perforation | 3 months | |
Secondary | Histologically confirmed full-thickness resection | Histologically confirmed full-thickness resection | 30 days |
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