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
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ospedale Dei Castelli
🇮🇹Ariccia, Rome, Italy
Ospedale Dei Castelli🇮🇹Ariccia, Rome, Italy