French Colorectal ESD Cohort in Experts Centers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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French Colorectal ESD Cohort in Experts Centers

Conditions
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Cancer Colorectal, Polyps Colorectal, Endoscopic Submucosal Resection

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Portion of R0 | Resection rate | Month 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative recurrence rate at follow-up colonoscopy | Cumulative recurrence rate at follow-up colonoscopy | Month 6 | 
| Cumulative bloc resection rate | Cumulative bloc resection rate | Day 1 | 
| Cumulative bloc resection rate with exclusive ESD | Cumulative bloc resection rate with exclusive ESD | Day 1 | 
| Cumulative curative resection rate | Cumulative curative resection rate | Month 1 | 
| Endoscopic curative resection rate without surgery | Endoscopic curative resection rate without surgery | Month 36 | 
| Cumulative surgical referral rate | Cumulative surgical referral rate | Month 12 | 
| Compare the proportion of technical failure | Compare the proportion of technical failure | Day 1 | 
| Cumulative histological prediction according to optical diagnosis | Cumulative histological prediction according to optical diagnosis | Month 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer colorectal, Polyps colorectal, Endoscopic submucosal resection