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

University of Roma La Sapienza

Status: Completed

Conditions: Colorectal Neoplasms

Treatments: Procedure: Endoscopic Submucosal Dissection (ESD); Procedure: Endoscopic Full-Thickness Resection (EFTR)

Study type: Interventional

Funder types: Other

Identifiers

NCT05502276

RESECT

Details and patient eligibility

About

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

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients of age >18 years
• Laterally Spreading Tumor Non Granular Type (LST-NG) ≤ 3cm in diameter
• "no-lift" colic injuries ≤ 3cm in diameter
• residual / recurrence on the scar of previous endoscopic resections of the colon ≤ 3cm in diameter

Exclusion criteria

• pregnant women
• failure to accept or understand the consent to participate in the study
• patients with severe coagulopathies
• patients with short life expectancy (Charlson comorbidity index ≥8)
• patients with expired general clinical conditions (American Society of Anesthesiologists score ≥3)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Endoscopic Submucosal Dissection (ESD)

Active Comparator group

Description:

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.

Treatment:

Procedure: Endoscopic Submucosal Dissection (ESD)

Endoscopic Full-Thickness Resection (EFTR)

Experimental group

Description:

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.

Treatment:

Procedure: Endoscopic Full-Thickness Resection (EFTR)