Endoscopic Full-Thickness Resection In Colon

Colorectal Cancer Clinical Trial

— EFTRICOM  

Official title:

Multicenter Prospective Study of Endoscopic Full-thickness Resection (EFTR) in Colon Using Over-the-scope-clip (OTSC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03803891
• Other study ID #: HU-EMPRET
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenoma
• Colo-rectal Cancer
• Colon Lesion
• Colon Neoplasm
• Colon Neoplasm, Malignant
• Colon Polyp
• Colonic Adenoma
• Colonic Cancer
• Colonic Neoplasms
• Colorectal Adenocarcinoma
• Colorectal Cancer
• Colorectal Neoplasms
• Neoplasms

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