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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic submucosal dissection | Procedure | Endoscopic submucosal dissection |
|
| 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 |
| 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 |
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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
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All patients addressed for a colorectal ESD
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Jérémie Jacques, Pr | Service d'Hépato-Gastro-Entérologie et Nutrition du CHU de LIMOGES | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Amiens | Recruiting | Amiens | 80054 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41083216 | Derived | 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. | |
| 38684193 |
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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 |
| 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 |
| Clinique de l'Anjou | Recruiting | Angers | 49044 | France |
|
| CHU de Besançon | Recruiting | Besançon | 25000 | France |
|
| CHU de Bordeaux | Recruiting | Bordeaux | 33400 | France |
|
| CHRU de Brest | Recruiting | Brest | 29200 | France |
|
| CHU de Dijon | Recruiting | Dijon | 21000 | France |
|
| CHU de Limoges | Recruiting | Limoges | 87045 | France |
|
| Hopital Edouard Herriot | Recruiting | Lyon | 69003 | France |
|
| Hôpital Jean Mermoz | Recruiting | Lyon | 69008 | France |
|
| Hôpital Européen | Recruiting | Marseille | 13003 | France |
|
| CHU de Montpellier | Recruiting | Montpellier | 34090 | France |
|
| CHU de Nancy | Recruiting | Nancy | 54035 | France |
|
| Clinique Jules Vernes | Recruiting | Nantes | 44000 | France |
|
| CHU de Nantes | Recruiting | Nantes | 44093 | France |
|
| CHU de Nice | Recruiting | Nice | 06200 | France |
|
| CHU de Nîmes | Recruiting | Nîmes | 30029 | France |
|
| Hôpital St Antoine | Recruiting | Paris | 75012 | France |
|
| Hôpital Cochin - APHP | Recruiting | Paris | 75014 | France |
|
| Hôpital St Joseph | Recruiting | Paris | 75014 | France |
|
| Hôpital Européen Georges Pompidou-APHP | Recruiting | Paris | 75015 | France |
|
| CHU de Rennes | Recruiting | Rennes | 35000 | France |
|
| CHU de Rouen | Recruiting | Rouen | 76031 | France |
|
| Clinique Santé Atlantique | Recruiting | Saint-Herblain | 44800 | France |
|
| CHU de Strasbourg | Recruiting | Strasbourg | 67000 | France |
|
| CHU de Toulouse | Recruiting | Toulouse | 31400 | France |
|
| 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. |
| 37500072 | 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. |
| 35649429 | 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. |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000069916 | Endoscopic Mucosal Resection |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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