French Colorectal ESD Cohort in Experts Centers

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Endoscopic submucosal dissection
  Endoscopic submucosal dissection

Первичные конечные точки

• R0 Resection rate of submucosal dissection for superficial colorectal lesions [Срок оценки: Month 1]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

All patients addressed for a colorectal ESD

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 25 центров

• 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
• … и ещё 17 центров

Публикации

• 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

Идентификаторы

NCT: NCT04592003 · 87RI20-0021_FECCo

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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