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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date December 2018
Source Fundació Institut Germans Trias i Pujol
Contact Hugo I. Uchima Koecklin, MD
Phone +34 934978866
Email hugoikuo@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Intervention

Procedure:
Endoscopic full-thickness resection
Endoscopic full-thickness resection (EFTR) with Over-The-Scope-Clip in colorectal lesions

Locations

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

Sponsors (19)

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

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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

Outcome

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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