Endoscopic Submucosal Dissection (ESD) Versus Endoscopic Mucosal Resection (EMR) for Large Non Pedunculated Colonic Adenomas: a Randomized Comparative Trial (RESECT COLON)

Initially developed in Japan for the treatment of endemic superficial gastric cancers, endoscopic submucosal dissection (ESD) allows resection of pre-neoplastic and neoplastic lesions of the digestive tract into a single fragment. It allows a perfect pathological analysis, and decreases the rate of recurrence of the adenoma to less than 2% However, this procedure, which is technically more challenging, is also more risky (perforation rate at 4% vs. 1% for WF-EMR) and longer. Submucosal dissection is also more expensive in terms of equipment, but this difference can be offset by the cost of the high number of iterative colonoscopies required in patients who have had endoscopic resection by WF-EMR.

Scientific debate is agitating the Western world1,2 and Japanese experts do not perform WF-EMR anymore, whereas no comparative prospective study has compared these two procedures.

We therefore propose to compare these two endoscopic resection strategies in terms of recurrence rate at 6 months and to estimate the differential cost-effectiveness and cost-utility ratios over a 36-month time horizon.

Study Overview

• Status: Active, not recruiting
• Conditions: Colonic Polyp
• Intervention / Treatment: Procedure: Experimental procedure : ESD; Procedure: Comparison procedure: WF-piece meal EMR

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: JEREMIE JACQUES, Dr; Phone Number: + 33 (0) 5 55 05 88 72; Email: jeremie.jacques@chu-limoges.fr

Study Locations

• France
  • Limoges, France, 87042
    • University Hospital, Limoges
  • Lyon, France, 69437
    • Edouard Herriot Hospital
  • Lyon, France, 69008
    • Jean Mermoz Hospital
  • Nancy, France, 54500
    • Nancy University Hospital
  • Paris, France, 75014
    • Cochin Hospital
  • Rennes, France, 35033
    • Pontchaillou Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient suffering from non-pedunculated polyp suspected larger than 25 mm in the colon
• Colon localization beyond 15 cm of the anal margin.
• Indication for endoscopic treatment
• Patients aged ≥ 18 years old
• Patients able to fill in questionnaires written in French

Exclusion Criteria:

• Prior endoscopic resection attempt
• Contra-indication to colonoscopy
• Contra-indication to general anesthesia
• Inability to stop antiplatelet agents and anti-coagulant according to the European Society of Gastro-Intestinal Endoscopy guidelines.
• Recurrent adenoma: post-endoscopic or surgical resection
• Pregnant or lactating women
• Genetic polyposis (Familial Adenomatous Polyposis, Lynch Syndrome, Peutz-Jeghers Syndrome)
• Inability to provide informed consent
• Patient under legal protection and or deprived of liberty by judicial or administrative decision
• Patient already participating in an interventional clinical research protocol
• Patient who cannot be followed for the duration of the study
• Non-pedunculated polyp ≤ 25 mm
• More than one lesion > 25 mm that fulfilled the inclusion criteria
• Suspicion of deep submucosal cancer by analysis of macroscopic appearance (Paris 0-III), vascular pattern and pit pattern (SANO IIIB, KUDO Vn)
• Non granular pseudodepressed Laterally spreading tumors due to the high risk of nonvisible submucosal cancer
• Polyp involving the appendice deeply (type 2 or 3 of classification of Toyonaga)
• Polyp inside the ileo-caecal valvula
• Tattoing under the lesionInflammatory Bowel Disease with expected fibrosis (Crohn disease or ulcerative colitis)
• Colon localization < 15 cm of the anal margin.
• Polyp invading a diverticulum
• Pedunculated polyp
• Absence of lesion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endoscopic submucosal dissection (ESD)	Procedure: Experimental procedure : ESD; ESD is a new endoscopic resection procedure that allows en-bloc resection for large superficial colorectal neoplasms. It used dedicated devices and consists in a deep submucosal dissection under the lesion after surelevation thanks to submucosal fluid injection and mucosal incision all around the lesion. The en bloc resection allows a perfect pathological analysis and a very low risk of recurrence (<1.5%)
Active Comparator: Endoscopic Mucosal Resection (WF-piece meal EMR)	Procedure: Comparison procedure: WF-piece meal EMR; WF-piece meal EMR is an older endoscopic resection technique. After surelevation of the lesion thanks to fluid submucosal injection, the precancerous lesion is resected in several pieces using a polypectomy snare. At the end of the procedure when macroscopically visible adenoma has been totally resected a snare tip coagulation of the margin of the scar is performed to destroy potential non visible residual adenoma. This procedure is quicker, safer than ESD but result in more recurrent disease (from 10 to 30% for lesions larger than 25 mm).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare recurrence rate at follow-up colonoscopy	Compare between two groups	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of R0 resection rate	Compare between two groups	Month 1
Cumulative complications rate after treatment	Compare between two groups	Month 1
Endoscopic curative resection rate without surgery	Compare between two groups	Month 36
Quality of life over time	Compare between two groups at Month 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36	Month 36
Cost-effectiveness ratio	Compare between two groups	Month 36
Cost-utility ratio	Compare between two groups	Month 36
Cumulative surgical referral rate	Compare between two groups	Month 36
Compare the proportion of technical failure	Compare between two groups	Day 1

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2019
• Primary Completion (Actual): September 28, 2021
• Study Completion (Estimated): April 28, 2024

Study Registration Dates

• First Submitted: May 22, 2019
• First Submitted That Met QC Criteria: May 22, 2019
• First Posted (Actual): May 24, 2019

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Endoscopic submucosal dissection; Endoscopic Mucosal Resection; Colonic Polyp; colonic adenoma; large non pedunculated
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Adenoma; Colonic Polyps
• Other Study ID Numbers: 87RI18_0002 (RESECT COLON)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No