Clinical trial NCT03803891: Endoscopic Full-Thickness Resection In Colon
Official title: Multicenter Prospective Study of Endoscopic Full-thickness Resection (EFTR) in Colon Using Over-the-scope-clip (OTSC)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colon Neoplasm, Malignant
Colo-rectal Cancer
Colonic Cancer
Colonic Adenoma
Colorectal Cancer
Colorectal Neoplasms
Colorectal Adenocarcinoma
Colon Polyp
Colon Lesion
Colon Neoplasm
Keywords: Endoscopic resection
Colonoscopy
Full-thickness resection
Lead sponsor: Fundació Institut Germans Trias i Pujol
Sponsor class: OTHER
Collaborators: name: Spanish Society of Digestive Endoscopy
name: Hospital de Sant Joan Despí Moisès Broggi
name: Complejo Hospitalario de Navarra
name: Hospital Clínico Universitario de Santiago de Compostela
name: Hospital Provincial de Castellon
name: Althaia Xarxa Assistencial Universitària de Manresa
name: Hospital Mutua de Terrassa
name: Hospital General Universitario Gregorio Marañon
name: Hospital San Carlos, Madrid
name: Hospital Universitario 12 de Octubre
name: Hospital General de Ciudad Real
name: Hospital General Universitario Elche
name: Hospital Universitario Central de Asturias
name: Hospital Clinic of Barcelona
name: Quironsalud
name: Hospital Universitario La Paz
name: Centro Medico Teknon
name: Germans Trias i Pujol Hospital
First posted: 2019-01-15
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who undergo a endoscopic full-thickness resection for colonic lesions who meet the inclusion criteria will be included consecutively.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Technical Success
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Major adverse events
timeFrame: 3 months
measure: Histologically confirmed full-thickness resection
timeFrame: 30 days
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: Manresa
country: Spain
facility: Fundació Althaia, Xarxa Assistencial Universitària de Manresa
state: Barcelona
city: Sant Joan Despí
country: Spain
facility: Hospital de Sant Joan Despí Moisès Broggi
state: Barcelona
city: Sant Joan Despí
country: Spain
facility: Hospital de Sant Joan Despí Moisès Broggi
state: Barcelona
city: Sant Joan Despí
country: Spain
facility: Hospital de Sant Joan Despí Moisès Broggi
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Universitari Mútua de Terrassa
state: Barcelona
city: Castelló de la Plana
country: Spain
facility: Consorcio Hospitalario Provincial de Castellón
state: Castellón
city: Santiago De Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago de Compostela
state: La Coruña
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Ciudad Real
country: Spain
facility: Hospital General Universitario de Ciudad Real
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Málaga
country: Spain
facility: Hospital Quirónsalud Málaga
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
Study officials:
affiliation: Medical researcher
name: Hugo I. Uchima Koecklin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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
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.
citation: 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.