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.

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

Study Overview

• Status: Recruiting
• Conditions: Cancer Colorectal; Polyps Colorectal; Endoscopic Submucosal Resection
• Intervention / Treatment: Procedure: Endoscopic submucosal dissection

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.

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

• Study Type: Observational
• Enrollment (Estimated): 1200

Contacts and Locations

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

Study Locations

• France
  • Amiens, France, 80054
    • Recruiting
    • CHU d'Amiens
    • Contact: Clara CY YZET, Dr; Email: yzet.clara@chu-amiens.fr
  • Angers, France, 49044
    • Recruiting
    • Clinique de l'Anjou
    • Contact: Edouard EC CHABRUN, Dr; Email: echabrun@gmail.com
  • Besançon, France, 25000
    • Recruiting
    • CHU de Besançon
    • Contact: Stéphane SK KOCH, Dr; Email: stephkoch65@gmail.com
  • Bordeaux, France, 33400
    • Recruiting
    • CHU de Bordeaux
    • Contact: Arthur AB BERGER, Dr; Email: arthur.berger@chu-bordeaux.fr
  • Brest, France, 29200
    • Recruiting
    • CHRU de Brest
    • Contact: Lucille LQ QUENERHVE, Dr; Email: lucille.queneherve@gmail.com
  • Dijon, France, 21000
    • Recruiting
    • CHU de Dijon
    • Contact: Thibault TD DEGAND, Dr; Email: thibault.degand@chu-dijon.fr
  • Limoges, France, 87045
    • Recruiting
    • CHU de Limoges
    • Contact: Jérémie JJ Jacques, Pr; Phone Number: 05 55 05 87 72; Email: jérémie.jacques@chu-limoges.fr
  • Lyon, France, 69008
    • Recruiting
    • Hôpital Jean Mermoz
    • Contact: Vincent VL LEPILLIEZ, Dr
    • Contact: Sarah SL LEBALNC, Dr; Email: arahleblanc34@hotmail.com
  • Lyon, France, 69003
    • Recruiting
    • Hôpital Edouard Herriot
    • Contact: Mathieu MP PIOCHE, Pr; Email: mathieu.pioche@chu-lyon.fr
  • Marseille, France, 13003
    • Recruiting
    • Hôpital Européen
    • Contact: Maxime MP PALAZZO, Dr; Email: palazzomaxime@gmail.com
  • Montpellier, France, 34090
    • Recruiting
    • CHU de Montpellier
    • Contact: Antoine AB DEBOURDEAU, Dr; Email: a-debourdeau@chu-montpellier.fr
  • Nancy, France, 54035
    • Recruiting
    • CHU de NANCY
    • Contact: Jean-Baptiste JBC CHEVAUX, Dr; Email: JB.CHEVAUX@chru-nancy.fr
  • Nantes, France, 44093
    • Recruiting
    • CHU de Nantes
    • Contact: Emmanuel EC CORON, Pr; Email: Emmanuel.CORON@chu-nantes.fr
  • Nantes, France, 44000
    • Recruiting
    • Clinique Jules Vernes
    • Contact: Bertrand BB BRIEAU, Dr; Email: bertrand.brieau@gmail.com
  • Nice, France, 06200
    • Recruiting
    • CHU de Nice
    • Contact: Geoffroy VANBIERVLIET GW Geoffroy VANBIERVLIET, Pr; Email: vanbiervliet.g@chu-nice.fr
  • Nîmes, France, 30029
    • Recruiting
    • CHU de Nîmes
    • Contact: Ludovic LC CAILLO, Dr; Email: ludovic.caillo@chu-nimes.fr
  • Paris, France, 75014
    • Recruiting
    • Hopital Cochin - APHP
    • Contact: Stanislas SC CHAUSSADE, Pr; Email: stanislas.chaussade@aphp.fr
  • Paris, France, 75012
    • Recruiting
    • Hopital St Antoine
    • Contact: Xavier XD DRAY, Dr; Email: xavier.dray@aphp.fr
  • Paris, France, 75014
    • Recruiting
    • Hôpital St Joseph
    • Contact: Yann YLB LE-BALEUR, Dr; Email: ylebaleur@hpsj.fr
  • Paris, France, 75015
    • Recruiting
    • Hôpital Européen Georges Pompidou-APHP
    • Contact: Gabriel GR RAHMI, Pr; Email: gabriel.rahmi@aphp.fr
  • Rennes, France, 35000
    • Recruiting
    • CHU de Rennes
    • Contact: Timothee TW WALLENHORST, Dr; Email: timothee.wallenhorst@chu-rennes.fr
  • Rouen, France, 76031
    • Recruiting
    • CHU de Rouen
    • Contact: Chloé CM MELCHIOR, Pr; Email: chloe.melchior@chu-rouen.fr
  • Saint-Herblain, France, 44800
    • Recruiting
    • Clinique Santé Atlantique
    • Contact: Nicolas MUSQUER, Dr; Email: drnicolasmusquer@outlook.fr
  • Strasbourg, France, 67000
    • Recruiting
    • CHU de Strasbourg
    • Contact: Lucile LH HEROIN, Dr; Email: lucileheroin@gmail.com
  • Toulouse, France, 31400
    • Recruiting
    • CHU de Toulouse
    • Contact: Karl KB BARANGE, Dr; Email: barange.k@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

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

• 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?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Endoscopic submucosal dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopic recurrence rate during the first endoscopic follow-up	Recurrence during the first endoscopic follow-up will be defined by the presence of adenoma or adenocarcinoma at the resection scar, whether visible or not, and confirmed by systematic biopsies of the resection scar.	Month 6
Monobloc resection rate	Monobloc resection is defined as resection of the lesion in a single piece.	Day 1
Monobloc resection rate exclusively in ESD.	Monobloc resection exclusively by ESD is defined as resection of the lesion in a single piece using submucosal dissection only, without the use of a diathermic loop (hybrid technique).	Day 1
Curative resection rate	Curative resection is defined according to the recommendations of the European Society of Digestive Endoscopy as a monobloc R0 dissection without any negative anatomopathological criteria (well-differentiated lesion, no emboli, no budding > 1, submucosal infiltration < 1 mm).	Month 1
Optimal dissection rate	Optimal dissection is defined as exclusive R0 dissection without perforation, with a resection speed > 20 mm2/min.	Month 1
30-day complication rate	Per-procedural perforation: breach of the colonic musculature with visualization of the peritoneal cavity.; Post-procedural perforation (≤ 30 days): abdominal pain associated with fever or inflammatory syndrome and presence of extraluminal air on abdominal-pelvic CT scan, in the absence of per-procedural perforation.; Per-procedural hemorrhage: considered a complication only if it leads to interruption of the procedure.; Post-procedural hemorrhage: rectal bleeding or melena requiring hospitalization (or prolonged hospitalization) or endoscopic hemostasis.	Month 1
Curative endoscopic resection rate without surgical management at 36 months	Curative endoscopic resection without surgery is defined by the absence of adenoma or adenocarcinoma at the resection scar after 36 months of follow-up, regardless of the number of endoscopic treatments required.	Month 36
Number of metachronous colorectal lesions at 36 months	A metachronous lesion is defined as the presence of a new superficial colorectal lesion during one of the endoscopic checks, a lesion not visualized during one of the previous examinations.	Month 36
Surgery rate at 36 months	Any colorectal surgery will be taken into account, whether due to failure of the endoscopic procedure, recurrence, a complication of the procedure, or an anatomopathological reason.	Month 36
Recurrence rate at 36 months	Recurrence at 36 months will be defined by the presence of adenoma or adenocarcinoma at the resection scar, whether visible or not, and confirmed by systematic biopsies of the resection scar.	Month 36
Effectiveness of histological prediction of superficial colorectal lesions treated according to the technological tools used.	The histological prediction of resected lesions will be established using validated classifications (Paris, SANO, NICE, KUDO, JNET, CONECTT). It will be compared with the definitive histological results to assess their sensitivity, specificity, and diagnostic accuracy within the cohort.	Month 1
Impact of center volume on oncological outcomes, technical outcomes, and procedural complications.	Oncological, technical, and complication outcomes will be analyzed according to the annual volume of the centers (low volume = < 50 ESDs per year; intermediate volume = between 50 and 100 procedures per year; high volume = > 100 procedures per year).	Month 1
Compare oncological and technical outcomes and procedural complications based on colonic or rectal location.	Oncological, technical, and complication outcomes will be analyzed according to the colonic or rectal location of the lesion.	Month 1
Compare procedural outcomes based on the different traction strategies used	Oncological, technical, and complication outcomes will be analyzed according to the traction system used for the procedure, matching lesions according to difficulty criteria validated by the literature.	Month 1
Analyze the learning curve of new trainees at the time of implementation of the submucosal dissection curriculum of the French Society of Digestive Endoscopy.	The learning curve of trainees will be used to evaluate oncological, technical, and complication outcomes using the LC CUSUM method.	statitistic analysis
Creation of a difficulty score predicting the success of ESD (R0 resection without perforation)	A difficulty score predicting success (R0 without perforation) will be created by performing a multivariate analysis according to the TRIPOD GUIDELINES using a derivation cohort and validated on a derivation cohort.	Month 1

Collaborators and Investigators

• Sponsor: University Hospital, Limoges
• Investigators: Principal Investigator: Jérémie Jacques, Pr, 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

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 (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Cancer colorectal; Polyps colorectal; Endoscopic submucosal resection
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Endoscopic Mucosal Resection
• 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