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

NCT ID: NCT05502276

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2022-09-30

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

Conditions

Colorectal Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Endoscopic Submucosal Dissection (ESD)

Intervention Type: PROCEDURE

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

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.

Group Type: EXPERIMENTAL

Endoscopic Full-Thickness Resection (EFTR)

Intervention Type: PROCEDURE

Full Thickness Endoscopic Resection using the FTRD Ovesco Device

Interventions

Endoscopic Full-Thickness Resection (EFTR)

Full Thickness Endoscopic Resection using the FTRD Ovesco Device

Intervention Type: PROCEDURE

Endoscopic Submucosal Dissection (ESD)

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

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Giulio Antonelli

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ospedale Dei Castelli

Ariccia, Rome, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 37390864 (View on PubMed)

Other Identifiers

RESECT

Identifier Type: -

Identifier Source: org_study_id