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

Not Applicable

Completed

• Conditions: Colorectal Neoplasms

• 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

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