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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
NameTimeMethod
En-bloc resection rate1 year

the rate of one-piece resection of the lesions

R0 resection rate1 year

percentage of patients with histologically negative lateral and deep margins

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Ospedale Dei Castelli

🇮🇹

Ariccia, Rome, Italy

Ospedale Dei Castelli
🇮🇹Ariccia, Rome, Italy

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