French Colorectal ESD Cohort in Experts Centers

NCT04592003 | Recruiting

• 1 other identifier: 87RI20-0021_FECCo
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 25

Brief Summary

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. The aim of this French multicenter cohort is to analyze the results of colorectal submucosal dissection on a large scale.

Conditions

Cancer Colorectal; Polyps Colorectal; Endoscopic Submucosal Resection

Keywords

Cancer colorectal; Polyps colorectal; Endoscopic submucosal resection

Outcome Measures

Primary Outcomes (1)

• R0 Resection rate of submucosal dissection for superficial colorectal lesions

  R0 Resection rate according to the definition of of the European Society of Gastrointestinal Endoscopy.

  Month 1

Secondary Outcomes (16)

• Endoscopic recurrence rate during the first endoscopic follow-up

  Month 6

• Monobloc resection rate

  Day 1

• Monobloc resection rate exclusively in ESD.

  Day 1

• Curative resection rate

  Month 1

• Optimal dissection rate

  Month 1

Study Arms (1)

FECCo : French Esd Colorectal Cohort in Experts Centers

All patients over 18 years of age referred for submucosal dissection of a polyp or a colorectal LST in the French centers participating in the cohort.

Procedure: Endoscopic submucosal dissection

Interventions

Endoscopic submucosal dissection PROCEDURE

Endoscopic submucosal dissection

FECCo : French Esd Colorectal Cohort in Experts Centers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients addressed for a colorectal ESD

You may qualify if:

• All patients addressed for a colorectal ESD

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (25)

CHU d'Amiens

Amiens, 80054, France

RECRUITING

Clinique de l'Anjou

Angers, 49044, France

RECRUITING

CHU de Besançon

Besançon, 25000, France

RECRUITING

CHU de Bordeaux

Bordeaux, 33400, France

RECRUITING

CHRU de Brest

Brest, 29200, France

RECRUITING

CHU de Dijon

Dijon, 21000, France

RECRUITING

CHU de Limoges

Limoges, 87045, France

RECRUITING

Hopital Edouard Herriot

Lyon, 69003, France

RECRUITING

Hôpital Jean Mermoz

Lyon, 69008, France

RECRUITING

Hôpital Européen

Marseille, 13003, France

RECRUITING

CHU de Montpellier

Montpellier, 34090, France

RECRUITING

CHU de Nancy

Nancy, 54035, France

RECRUITING

Clinique Jules Vernes

Nantes, 44000, France

RECRUITING

CHU de Nantes

Nantes, 44093, France

RECRUITING

CHU de Nice

Nice, 06200, France

RECRUITING

CHU de Nîmes

Nîmes, 30029, France

RECRUITING

Hôpital St Antoine

Paris, 75012, France

RECRUITING

Hôpital Cochin - APHP

Paris, 75014, France

RECRUITING

Hôpital St Joseph

Paris, 75014, France

RECRUITING

Hôpital Européen Georges Pompidou-APHP

Paris, 75015, France

RECRUITING

CHU de Rennes

Rennes, 35000, France

RECRUITING

CHU de Rouen

Rouen, 76031, France

RECRUITING

Clinique Santé Atlantique

Saint-Herblain, 44800, France

RECRUITING

CHU de Strasbourg

Strasbourg, 67000, France

RECRUITING

CHU de Toulouse

Toulouse, 31400, France

RECRUITING

Related Publications (4)

• Van der Voort V, Schaefer M, Wallenhorst T, Lepilliez V, Degand T, Le Baleur Y, Leclercq P, Berger A, Chabrun E, Brieau B, Barret M, Rahmi G, Legros R, Rivory J, Leblanc S, Vanbiervliet G, Alfarone L, Magne J, Zeevaert JB, Albouys J, Perrod G, Yzet C, Lepetit H, Belle A, Chaussade S, Rostain F, Dahan M, Lupu A, Chevaux JB, Pioche M, Jacques J; FECCo Group collaborators. Rectal versus colonic submucosal cancer rates and procedural outcomes in large non-pedunculated polyps: French ESD registry data. Gut. 2025 Oct 12:gutjnl-2024-332970. doi: 10.1136/gutjnl-2024-332970. Online ahead of print.

  PMID: 41083216 DERIVED

• Yzet C, Wallenhorst T, Jacques J, Figueiredo Ferreira M, Rivory J, Rostain F, Masgnaux LJ, Grimaldi J, Legros R, Lafeuille P, Albouys J, Subtil F, Schaefer M, Pioche M. Traction-assisted endoscopic submucosal dissection for resection of ileocecal valve neoplasia: a French retrospective multicenter case series. Endoscopy. 2024 Oct;56(10):790-796. doi: 10.1055/a-2316-4910. Epub 2024 Apr 29.

  PMID: 38684193 DERIVED

• Yzet C, Le Baleur Y, Albouys J, Jacques J, Doumbe-Mandengue P, Barret M, Abou Ali E, Schaefer M, Chevaux JB, Leblanc S, Lepillez V, Privat J, Degand T, Wallenhorst T, Rivory J, Chaput U, Berger A, Aziz K, Rahmi G, Coron E, Kull E, Caillo L, Vanbiervliet G, Koch S, Subtil F, Pioche M. Use of endoscopic submucosal dissection or full-thickness resection device to treat residual colorectal neoplasia after endoscopic resection: a multicenter historical cohort study. Endoscopy. 2023 Nov;55(11):1002-1009. doi: 10.1055/a-2116-9930. Epub 2023 Jul 27.

  PMID: 37500072 DERIVED

• 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.

  PMID: 35649429 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Jérémie Jacques, Pr

  Service d'Hépato-Gastro-Entérologie et Nutrition du CHU de LIMOGES

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jérémie Jacques, Pr

CONTACT

05 55 05 87 72; jeremie.jacques@chu-limoges.fr

Juge Sandra, Dr

CONTACT

05 55 05 64 14; sandra.juge@chu-limoges.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 19, 2020
• Study Start: January 1, 2020
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-08

Locations

FR (25)