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Recruiting NCT04592003

French Colorectal ESD Cohort in Experts Centers

— Observational Cancer Colorectal Polyps Colorectal Endoscopic Submucosal Resection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endoscopic submucosal dissection.
Who it may be relevant to
Registry conditions: Cancer Colorectal, Polyps Colorectal, Endoscopic Submucosal Resection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Interventions

  • Procedure Endoscopic submucosal dissection
    Endoscopic submucosal dissection

Primary outcome measures

  • R0 Resection rate of submucosal dissection for superficial colorectal lesions [Time frame: Month 1]
Secondary outcome measures (12)
  • Endoscopic recurrence rate during the first endoscopic follow-up [Time frame: Month 6]
  • Monobloc resection rate [Time frame: Day 1]
  • Monobloc resection rate exclusively in ESD. [Time frame: Day 1]
  • Curative resection rate [Time frame: Month 1]
  • Optimal dissection rate [Time frame: Month 1]
  • 30-day complication rate [Time frame: Month 1]
  • Curative endoscopic resection rate without surgical management at 36 months [Time frame: Month 36]
  • Number of metachronous colorectal lesions at 36 months [Time frame: Month 36]
  • Surgery rate at 36 months [Time frame: Month 36]
  • Recurrence rate at 36 months [Time frame: Month 36]
  • Effectiveness of histological prediction of superficial colorectal lesions treated according to the technological tools used. [Time frame: Month 1]
  • Impact of center volume on oncological outcomes, technical outcomes, and procedural complications. [Time frame: Month 1]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 25 centers
  • CHU d'Amiens — Amiens
  • Clinique de l'Anjou — Angers
  • CHU de Besançon — Besançon
  • CHU de Bordeaux — Bordeaux
  • CHRU de Brest — Brest
  • CHU de Dijon — Dijon
  • CHU de Limoges — Limoges
  • Hopital Edouard Herriot — Lyon
  • … and 17 more centers

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 submu PMID 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. PMID 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 a PMID 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. PMID 35649429

Identifiers

NCT: NCT04592003 · 87RI20-0021_FECCo

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗