Endoscopic Full-Thickness Resection In Colon

• Conditions: Colo-rectal Cancer; Colorectal Cancer; Colon Neoplasm, Malignant; Colonic Cancer; Colon Polyp; Colon Lesion; Colonic Adenoma; Colorectal Adenocarcinoma; Colon Neoplasm; Colorectal Neoplasms
• Interventions: Procedure: Endoscopic full-thickness resection

• Registration Number: NCT03803891
• Lead Sponsor: Fundació Institut Germans Trias i Pujol

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.

Study Timeline

• Study Start: 2018-05-01
• Status Verified: 2018-12
• Study First Submitted: 2018-12-17
• Study First Submitted QC: 2019-01-10
• Last Update Submitted: 2019-01-10
• Study First Posted: 2019-01-15
• Last Update Posted: 2019-01-15
• Primary Completion: 2020-01-31
• Study Completion: 2020-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 65

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endoscopic full-thickness resection	Endoscopic full-thickness resection	Patients with neoplastic lesions less than 30mm unresectable en bloc by other less invasive endoscopic techniques, including lesions suggestive of T1 colorectal cancer, subepithelial tumors, lesions with diverticular involvement, lesions with no-lifting sign (recurrent, incomplete prior resection or untreated lesions).

Primary Outcome Measures

Name	Time	Method
Technical Success	Through study completion, an average of 1 year	Percentage of complete en-bloc resection of the lesion without macroscopic residual tissue after completing the endoscopic full-thickness resection

Secondary Outcome Measures

Name	Time	Method
Histologically confirmed full-thickness resection	30 days	Histologically confirmed full-thickness resection
Major adverse events	3 months	Percentage of procedure-associated major adverse events: bleeding and/or perforation

Trial Locations

Locations (15)

Hospital General Universitario de Ciudad Real; 🇪🇸 Ciudad Real, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Complejo Hospitalario de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Hospital Clínico Universitario de Santiago de Compostela; 🇪🇸 Santiago De Compostela, La Coruña, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitari Mútua de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain

Hospital Quirónsalud Málaga; 🇪🇸 Málaga, Spain

Hospital de Sant Joan Despí Moisès Broggi; 🇪🇸 Sant Joan Despí, Barcelona, Spain

Fundació Althaia, Xarxa Assistencial Universitària de Manresa; 🇪🇸 Manresa, Barcelona, Spain

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Spain

Hospital General Universitario de Elche; 🇪🇸 Elche, Alicante, Spain

Consorcio Hospitalario Provincial de Castellón; 🇪🇸 Castelló de la Plana, Castellón, Spain