Endoscopic Full-Thickness Resection In Colon

Last updated: January 10, 2019
Sponsor: Fundació Institut Germans Trias i Pujol
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colorectal Cancer

Rectal Cancer

Colon Cancer; Rectal Cancer

Treatment

N/A

Clinical Study ID

NCT03803891
HU-EMPRET
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults (≥18 years) of both sexes.

  • Colonic lesions less than 30mm unresectable en-bloc by other less invasive endoscopictechniques, including lesions suggestive of T1, subepithelial tumors, lesions withdiverticular involvement, lesions with no-lifting signs (recurrent, incomplete priorresection or untreated).

  • Patients who give their written informed consent for the procedure and for the study.

Exclusion

Exclusion Criteria:

  • Refusal to grant informed consent.

  • Neoplastic lesions of the colon with evidence of advanced stage (for example, lymphnode involvement) or more than 3 cm in greatest diameter.

  • Any medical, psychological, geographical, or social problem that is significant anduncontrolled that may interfere with the patient's participation in the study or thatdoes not allow adequate follow-up and adherence to the protocol and evaluation of theresults of the study.

Study Design

Total Participants: 65
Study Start date:
May 01, 2018
Estimated Completion Date:
July 31, 2020

Study 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.

Connect with a study center

  • Hospital General Universitario de Elche

    Elche, Alicante 03203
    Spain

    Active - Recruiting

  • Fundació Althaia, Xarxa Assistencial Universitària de Manresa

    Manresa, Barcelona 08243
    Spain

    Active - Recruiting

  • Hospital de Sant Joan Despí Moisès Broggi

    Sant Joan Despí, Barcelona 08970
    Spain

    Active - Recruiting

  • Hospital Universitari Mútua de Terrassa

    Terrassa, Barcelona 08221
    Spain

    Active - Recruiting

  • Consorcio Hospitalario Provincial de Castellón

    Castelló de la Plana, Castellón 12002
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Santiago de Compostela

    Santiago De Compostela, La Coruña 15706
    Spain

    Active - Recruiting

  • Complejo Hospitalario de Navarra

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Hospital Clínic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital General Universitario de Ciudad Real

    Ciudad Real, 13005
    Spain

    Active - Recruiting

  • Hospital Clínico San Carlos

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Quirónsalud Málaga

    Málaga, 29004
    Spain

    Active - Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, 33011
    Spain

    Active - Recruiting

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