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

Sponsor

University of Roma La Sapienza (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05502276

Collaborator

(none)

Enrollment

Location

Arms

44.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Colorectal Neoplasms	Procedure: Endoscopic Full-Thickness Resection (EFTR) Procedure: Endoscopic Submucosal Dissection (ESD)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Feb 28, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Endoscopic Submucosal Dissection (ESD) 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.	Procedure: Endoscopic Submucosal Dissection (ESD) Standard Endoscopic Submucosal Dissection using standard procedure described in international guidelines.
Experimental: Endoscopic Full-Thickness Resection (EFTR) 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.	Procedure: Endoscopic Full-Thickness Resection (EFTR) Full Thickness Endoscopic Resection using the FTRD Ovesco Device

Arm

Intervention/Treatment

Active Comparator: Endoscopic Submucosal Dissection (ESD)

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.

Procedure: Endoscopic Submucosal Dissection (ESD)

Standard Endoscopic Submucosal Dissection using standard procedure described in international guidelines.

Experimental: Endoscopic Full-Thickness Resection (EFTR)

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.

Procedure: Endoscopic Full-Thickness Resection (EFTR)

Full Thickness Endoscopic Resection using the FTRD Ovesco Device

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale Dei Castelli	Ariccia	Rome	Italy	00040

Sponsors and Collaborators

University of Roma La Sapienza

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Giulio Antonelli, Principal Investigator, University of Roma La Sapienza

ClinicalTrials.gov Identifier:

NCT05502276

Other Study ID Numbers:

RESECT

First Posted:

Aug 16, 2022

Last Update Posted:

Aug 16, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of Aug 16, 2022