NCT03803891

Endoscopic Full-Thickness Resection In Colon

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 65 (estimated)
• Sponsor: Fundació Institut Germans Trias i Pujol · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Endoscopic full-thickness resection	Endoscopic full-thickness resection (EFTR) with Over-The-Scope-Clip in colorectal lesions

Timeline

• Start date: 2018-05-01
• Primary completion: 2020-01-31
• Completion: 2020-07-31
• First posted: 2019-01-15
• Last updated: 2019-01-15

Locations

17 sites across 1 country: Spain