Full Thickness Resection or Endoscopic Submucosal Dissection for Difficult Colorectal Lesions.

Not Applicable

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Procedure: Endoscopic Submucosal Dissection (ESD); Procedure: Endoscopic Full-Thickness Resection (EFTR)

• Registration Number: NCT05502276
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

Compare the efficacy and safety of endoscopic resection a full thickness (EFTR) with Full Thickness Resection Device (FTRD) System versus endoscopic submucosal dissection (ESD) in the treatment of Laterally Spreading Tumor Non Granular Type (LST-NG), "no lift" lesions colon and residual / relapse on scars from previous resections endoscopic colon. The dimensional cut off of these lesions is ≤30mm

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2022-02-28
• Study First Submitted: 2022-08-12
• Study First Submitted QC: 2022-08-12
• Study First Posted: 2022-08-16
• Study Completion: 2022-09-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endoscopic Submucosal Dissection (ESD)	Endoscopic Submucosal Dissection (ESD)	The Endoscopic Submucosal Dissection (ESD) procedures will be performed with the devices commonly used at the Services of Endoscopy of the Centers participating in the study. There are several models of knives on the market, produced by different companies, all considered equally effective by international guidelines.
Endoscopic Full-Thickness Resection (EFTR)	Endoscopic Full-Thickness Resection (EFTR)	The FTRD® (Full Thickness Resection Device; Ovesco Endoscopy, Tübingen, Germany) is the only over-the-scope device designed to undergo Endoscopic Full-Thickness Resection (EFTR) using a "clip-and-cut" technique. It consists of a 14 mm modified over-the-scope-clip (OTSC) mounted on the outside of a 23 mm cap, which has a preloaded 13 mm monofilament loop at the end. This device received the CE mark for the lower digestive tract in September 2014 and its efficacy and safety have been evaluated in preclinical studies and clinical trials.

Primary Outcome Measures

Name	Time	Method
En-bloc resection rate	1 year	the rate of one-piece resection of the lesions
R0 resection rate	1 year	percentage of patients with histologically negative lateral and deep margins

Trial Locations

Locations (1)

Ospedale Dei Castelli; 🇮🇹 Ariccia, Rome, Italy