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French Colorectal ESD Cohort in Experts Centers (FECCo)

U

University of Limoges (UL)

Status

Unknown

Conditions

Endoscopic Submucosal Resection
Polyps Colorectal
Cancer Colorectal

Study type

Observational

Funder types

Other

Identifiers

NCT04592003
87RI20-0021_FECCo

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Jérémie Jacques, Dr; Juge Sandra, Dr

Data sourced from clinicaltrials.gov

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