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Cancer ColorectalFECCoNCT04592003

French Colorectal ESD Cohort in Experts Centers

An observational study of Cancer Colorectal and Polyps Colorectal, run by University Hospital, Limoges at 25 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Endoscopic submucosal dissection
Type of treatment
Surgery or procedure
How many people
1,200 participants
Where
25 sitesFrance
Study dates
1 Jan 2020to 1 Jan 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients addressed for a colorectal ESD

Who may be able to join

  • All patients addressed for a colorectal ESD

Who cannot join

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

Trial locations and contacts

25 sites in 1 country. Contact the study team or a site near you to ask about taking part.

25 sites in 1 country

France25 sites, 25 recruiting
  • CHU d'Amiens

    Amiens, 80054

    Clara CY YZET, Dr, yzet.clara@chu-amiens.fr

    Recruiting
  • Clinique de l'Anjou

    Angers, 49044

    Edouard EC CHABRUN, Dr, echabrun@gmail.com

    Recruiting
  • CHU de Besançon

    Besançon, 25000

    Stéphane SK KOCH, Dr, stephkoch65@gmail.com

    Recruiting
  • CHU de Bordeaux

    Bordeaux, 33400

    Arthur AB BERGER, Dr, arthur.berger@chu-bordeaux.fr

    Recruiting
  • CHRU de Brest

    Brest, 29200

    Lucille LQ QUENERHVE, Dr, lucille.queneherve@gmail.com

    Recruiting
  • CHU de Dijon

    Dijon, 21000

    Thibault TD DEGAND, Dr, thibault.degand@chu-dijon.fr

    Recruiting
  • CHU de Limoges

    Limoges, 87045

    Jérémie JJ Jacques, Pr, 05 55 05 87 72, jérémie.jacques@chu-limoges.fr

    Recruiting
  • Hopital Edouard Herriot

    Lyon, 69003

    Mathieu MP PIOCHE, Pr, mathieu.pioche@chu-lyon.fr

    Recruiting
  • Hôpital Jean Mermoz

    Lyon, 69008

    Vincent VL LEPILLIEZ, Dr

    Sarah SL LEBALNC, Dr, arahleblanc34@hotmail.com

    Recruiting
  • Hôpital Européen

    Marseille, 13003

    Maxime MP PALAZZO, Dr, palazzomaxime@gmail.com

    Recruiting
  • CHU de Montpellier

    Montpellier, 34090

    Antoine AB DEBOURDEAU, Dr, a-debourdeau@chu-montpellier.fr

    Recruiting
  • CHU de Nancy

    Nancy, 54035

    Jean-Baptiste JBC CHEVAUX, Dr, JB.CHEVAUX@chru-nancy.fr

    Recruiting
  • Clinique Jules Vernes

    Nantes, 44000

    Bertrand BB BRIEAU, Dr, bertrand.brieau@gmail.com

    Recruiting
  • CHU de Nantes

    Nantes, 44093

    Emmanuel EC CORON, Pr, Emmanuel.CORON@chu-nantes.fr

    Recruiting
  • CHU de Nice

    Nice, 06200

    Geoffroy VANBIERVLIET GW Geoffroy VANBIERVLIET, Pr, vanbiervliet.g@chu-nice.fr

    Recruiting
  • CHU de Nîmes

    Nîmes, 30029

    Ludovic LC CAILLO, Dr, ludovic.caillo@chu-nimes.fr

    Recruiting
  • Hôpital St Antoine

    Paris, 75012

    Xavier XD DRAY, Dr, xavier.dray@aphp.fr

    Recruiting
  • Hôpital Cochin - APHP

    Paris, 75014

    Stanislas SC CHAUSSADE, Pr, stanislas.chaussade@aphp.fr

    Recruiting
  • Hôpital St Joseph

    Paris, 75014

    Yann YLB LE-BALEUR, Dr, ylebaleur@hpsj.fr

    Recruiting
  • Hôpital Européen Georges Pompidou-APHP

    Paris, 75015

    Gabriel GR RAHMI, Pr, gabriel.rahmi@aphp.fr

    Recruiting
  • CHU de Rennes

    Rennes, 35000

    Timothee TW WALLENHORST, Dr, timothee.wallenhorst@chu-rennes.fr

    Recruiting
  • CHU de Rouen

    Rouen, 76031

    Chloé CM MELCHIOR, Pr, chloe.melchior@chu-rouen.fr

    Recruiting
  • Clinique Santé Atlantique

    Saint-Herblain, 44800

    Nicolas MUSQUER, Dr, drnicolasmusquer@outlook.fr

    Recruiting
  • CHU de Strasbourg

    Strasbourg, 67000

    Lucile LH HEROIN, Dr, lucileheroin@gmail.com

    Recruiting
  • CHU de Toulouse

    Toulouse, 31400

    Karl KB BARANGE, Dr, barange.k@chu-toulouse.fr

    Recruiting

Other trials in France

About this study

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.

Read more

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.

Read the 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.

Being tested
Endoscopic submucosal dissection
Keywords
Cancer colorectal, Polyps colorectal, Endoscopic submucosal resection
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic submucosal dissectionProcedure or surgery

    Endoscopic submucosal dissection

Study groups in NCT04592003
Study groupRoleWhat they receive
FECCo : French Esd Colorectal Cohort in Experts CentersAll 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.
Receives: Procedure: Endoscopic submucosal dissection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Month 1

Secondary outcomes (16)
  1. 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.

    Measured: Month 6

  2. Monobloc resection rate

    Monobloc resection is defined as resection of the lesion in a single piece.

    Measured: Day 1

  3. 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).

    Measured: Day 1

  4. 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).

    Measured: Month 1

  5. Optimal dissection rate

    Optimal dissection is defined as exclusive R0 dissection without perforation, with a resection speed > 20 mm2/min.

    Measured: Month 1

  6. 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.

    Measured: Month 1

  7. 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.

    Measured: Month 36

  8. 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.

    Measured: Month 36

  9. 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.

    Measured: Month 36

  10. 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.

    Measured: Month 36

  11. 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.

    Measured: Month 1

  12. 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).

    Measured: Month 1

  13. 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.

    Measured: Month 1

  14. 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.

    Measured: Month 1

  15. 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.

    Measured: statitistic analysis

  16. 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.

    Measured: Month 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2020
  2. Study start1 Jan 2020
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion1 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04592003
Sponsor's protocol ID
87RI20-0021_FECCo
Acronym
FECCo
Status last verified
Aug 2025
First submitted
8 Oct 2020
Last updated
15 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 41083216
  • 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.

    PubMed 38684193
  • 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.

    PubMed 37500072
  • 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.

    PubMed 35649429

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer Colorectal and Polyps Colorectal, run by University Hospital, Limoges at 25 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jérémie Jacques, Pr (05 55 05 87 72, jeremie.jacques@chu-limoges.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

R0 Resection rate of submucosal dissection for superficial colorectal lesions (time frame: Month 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04592003, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.

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