French Colorectal ESD Cohort in Experts Centers

Cancer Colorectal Clinical Trial

— FECCo  

Official title:

French Colorectal ESD Cohort in Experts Centers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04592003
• Other study ID #: 87RI20-0021_FECCo
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 19, 2023

Study information

• Verified date: September 2020
• Source: University Hospital, Limoges
• Contact: Jérémie Jacques, Dr
• Phone: 05 55 05 87 72
• Email: jeremie.jacques[@]chu-limoges.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 19, 2023
• Est. primary completion date: December 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Colorectal
• Endoscopic Submucosal Resection
• Polyps
• Polyps Colorectal

Locations

Country	Name	City	State
France	CHU de LIMOGES	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Portion of R0	Resection rate	Month 1
Secondary	Cumulative recurrence rate at follow-up colonoscopy	Cumulative recurrence rate at follow-up colonoscopy	Month 6
Secondary	Cumulative bloc resection rate	Cumulative bloc resection rate	Day 1
Secondary	Cumulative bloc resection rate with exclusive ESD	Cumulative bloc resection rate with exclusive ESD	Day 1
Secondary	Cumulative curative resection rate	Cumulative curative resection rate	Month 1
Secondary	Endoscopic curative resection rate without surgery	Endoscopic curative resection rate without surgery	Month 36
Secondary	Cumulative surgical referral rate	Cumulative surgical referral rate	Month 12
Secondary	Compare the proportion of technical failure	Compare the proportion of technical failure	Day 1
Secondary	Cumulative histological prediction according to optical diagnosis	Cumulative histological prediction according to optical diagnosis	Month 1