Back to resultsFull Thickness Resection or Endoscopic Submucosal Dissection for Difficult Colorectal Lesions.
Primary Purpose
Colorectal Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Endoscopic Full-Thickness Resection (EFTR)
Endoscopic Submucosal Dissection (ESD)
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasms
Eligibility Criteria
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)
Sites / Locations
- Ospedale Dei Castelli
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Endoscopic Submucosal Dissection (ESD)
Endoscopic Full-Thickness Resection (EFTR)
Arm 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.
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.
Outcomes
Primary Outcome Measures
En-bloc resection rate
the rate of one-piece resection of the lesions
R0 resection rate
percentage of patients with histologically negative lateral and deep margins
Secondary Outcome Measures
Full Information
NCT ID
NCT05502276
First Posted
August 12, 2022
Last Updated
November 2, 2022
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT05502276
Brief Title
Full Thickness Resection or Endoscopic Submucosal Dissection for Difficult Colorectal Lesions.
Official Title
Endoscopic Full Thickness Resection (EFTR) Versus Endoscopic Submucosal Dissection (ESD) in the Treatment of Difficult Colorectal Lesions With Dimensional Cut-off ≤ 30mm: Laterally Spreading Tumor Non Granular Type (LST-NG), "no Lift" Lesions and Residual / Relapses of Previous Resections. Endoscopic.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endoscopic Submucosal Dissection (ESD)
Arm Type
Active Comparator
Arm 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.
Arm Title
Endoscopic Full-Thickness Resection (EFTR)
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Full-Thickness Resection (EFTR)
Intervention Description
Full Thickness Endoscopic Resection using the FTRD Ovesco Device
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Submucosal Dissection (ESD)
Intervention Description
Standard Endoscopic Submucosal Dissection using standard procedure described in international guidelines.
Primary Outcome Measure Information:
Title
En-bloc resection rate
Description
the rate of one-piece resection of the lesions
Time Frame
1 year
Title
R0 resection rate
Description
percentage of patients with histologically negative lateral and deep margins
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Ospedale Dei Castelli
City
Ariccia
State/Province
Rome
ZIP/Postal Code
00040
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Full Thickness Resection or Endoscopic Submucosal Dissection for Difficult Colorectal Lesions.
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