French Colorectal ESD Cohort in Experts Centers (FECCo)

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.

A lot of centers in France performed colorectal ESD even for benign lesions and nationwide data about safety and efficiency is required to confirm the place of ESD for treatment of large superficial colorectal lesions.

Study Overview

• Status: Recruiting
• Conditions: Cancer Colorectal; Polyps Colorectal; Endoscopic Submucosal Resection

Detailed Description

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.

A lot of centers in France performed colorectal ESD even for benign lesions and nationwide data about safety and efficiency is required to confirm the place of ESD for treatment of large superficial colorectal lesions.

• Study Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

• Study Contact: Name: Jérémie Jacques, Dr; Phone Number: 05 55 05 87 72; Email: jérémie.jacques@chu-limoges.fr
• Study Contact Backup: Name: Juge Sandra, Dr; Phone Number: 05 55 05 64 14; Email: sandra.juge@chu-limoges.fr

Study Locations

• France
  • Limoges, France, 87045
    • Recruiting
    • chu de Limoges
    • Contact: Jérémie Jacques, Dr; Phone Number: 05 55 05 87 72; Email: jérémie.jacques@chu-limoges.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients addressed for a colorectal ESD

Description

Inclusion Criteria:

All patients addressed for a colorectal ESD

Exclusion Criteria:

Opposition notified in the context of a non-opposition form after reading the information notice

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Portion of R0	Resection rate	Month 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative recurrence rate at follow-up colonoscopy	Cumulative recurrence rate at follow-up colonoscopy	Month 6
Cumulative bloc resection rate	Cumulative bloc resection rate	Day 1
Cumulative bloc resection rate with exclusive ESD	Cumulative bloc resection rate with exclusive ESD	Day 1
Cumulative curative resection rate	Cumulative curative resection rate	Month 1
Endoscopic curative resection rate without surgery	Endoscopic curative resection rate without surgery	Month 36
Cumulative surgical referral rate	Cumulative surgical referral rate	Month 12
Compare the proportion of technical failure	Compare the proportion of technical failure	Day 1
Cumulative histological prediction according to optical diagnosis	Cumulative histological prediction according to optical diagnosis	Month 1

Collaborators and Investigators

• Sponsor: University Hospital, Limoges
• Investigators: Principal Investigator: Jérémie Jacques, Dr, Service d'Hépato-Gastro-Entérologie et Nutrition du CHU de LIMOGES

Publications and helpful links

General Publications

• Patenotte A, Yzet C, Wallenhorst T, Subtil F, Leblanc S, Schaefer M, Walter T, Lambin T, Fenouil T, Lafeuille P, Chevaux JB, Legros R, Rostain F, Rivory J, Jacques J, Lepilliez V, Pioche M. Diagnostic endoscopic submucosal dissection for colorectal lesions with suspected deep invasion. Endoscopy. 2023 Feb;55(2):192-197. doi: 10.1055/a-1866-8080. Epub 2022 Jun 1.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): December 19, 2020
• Study Completion (Anticipated): December 19, 2023

Study Registration Dates

• First Submitted: October 8, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 12, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Cancer colorectal; Polyps colorectal; Endoscopic submucosal resection
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps
• Other Study ID Numbers: 87RI20-0021_FECCo

Drug and device information, study documents

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