French Colorectal ESD Cohort in Experts Centers
- Conditions
- Cancer ColorectalEndoscopic Submucosal ResectionPolyps Colorectal
- Registration Number
- NCT04592003
- Lead Sponsor
- University Hospital, Limoges
- Brief 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. 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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1500
All patients addressed for a colorectal ESD
Opposition notified in the context of a non-opposition form after reading the information notice
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Portion of R0 Month 1 Resection rate
- Secondary Outcome Measures
Name Time Method Cumulative recurrence rate at follow-up colonoscopy Month 6 Cumulative recurrence rate at follow-up colonoscopy
Cumulative bloc resection rate Day 1 Cumulative bloc resection rate
Cumulative bloc resection rate with exclusive ESD Day 1 Cumulative bloc resection rate with exclusive ESD
Endoscopic curative resection rate without surgery Month 36 Endoscopic curative resection rate without surgery
Cumulative surgical referral rate Month 12 Cumulative surgical referral rate
Compare the proportion of technical failure Day 1 Compare the proportion of technical failure
Cumulative histological prediction according to optical diagnosis Month 1 Cumulative histological prediction according to optical diagnosis
Cumulative curative resection rate Month 1 Cumulative curative resection rate
Trial Locations
- Locations (1)
CHU de LIMOGES
🇫🇷Limoges, France