NCT05502276

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

3.2 years

First QC Date

August 12, 2022

Last Update Submit

November 2, 2022

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (2)

  • En-bloc resection rate

    the rate of one-piece resection of the lesions

    1 year

  • R0 resection rate

    percentage of patients with histologically negative lateral and deep margins

    1 year

Study Arms (2)

Endoscopic Submucosal Dissection (ESD)

ACTIVE COMPARATOR

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)

Endoscopic Full-Thickness Resection (EFTR)

EXPERIMENTAL

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)

Interventions

Endoscopic Full-Thickness Resection (EFTR)PROCEDURE

Full Thickness Endoscopic Resection using the FTRD Ovesco Device

Endoscopic Full-Thickness Resection (EFTR)
Endoscopic Submucosal Dissection (ESD)PROCEDURE

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

Endoscopic Submucosal Dissection (ESD)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Dei Castelli

Ariccia, Rome, 00040, Italy

Location

Related Publications (1)

  • Andrisani G, Hassan C, Pizzicannella M, Pugliese F, Mutignani M, Campanale C, Valerii G, Barbera C, Antonelli G, Di Matteo FM. Endoscopic full-thickness resection versus endoscopic submucosal dissection for challenging colorectal lesions: a randomized trial. Gastrointest Endosc. 2023 Dec;98(6):987-997.e1. doi: 10.1016/j.gie.2023.06.009. Epub 2023 Jun 28.

    PMID: 37390864DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 12, 2022

First Posted

August 16, 2022

Study Start

January 1, 2019

Primary Completion

February 28, 2022

Study Completion

September 30, 2022

Last Updated

November 3, 2022

Record last verified: 2022-11

Locations

IT(1)