Clinical trial NCT04592003: French Colorectal ESD Cohort in Experts Centers
Official title: French Colorectal ESD Cohort in Experts Centers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer Colorectal
Polyps Colorectal
Endoscopic Submucosal Resection
Keywords: Cancer colorectal
Polyps colorectal
Endoscopic submucosal resection
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All patients addressed for a colorectal ESD

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.

Eligibility criteria: 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

Primary outcomes:
measure: Portion of R0
timeFrame: Month 1
Secondary outcomes:
measure: Cumulative recurrence rate at follow-up colonoscopy
timeFrame: Month 6
measure: Cumulative bloc resection rate
timeFrame: Day 1
measure: Cumulative bloc resection rate with exclusive ESD
timeFrame: Day 1
measure: Cumulative curative resection rate
timeFrame: Month 1
measure: Endoscopic curative resection rate without surgery
timeFrame: Month 36
measure: Cumulative surgical referral rate
timeFrame: Month 12
measure: Compare the proportion of technical failure
timeFrame: Day 1
measure: Cumulative histological prediction according to optical diagnosis
timeFrame: Month 1
Other outcomes:
Locations:
city: Limoges
country: France
facility: CHU de LIMOGES
Study officials:
affiliation: Service d'Hépato-Gastro-Entérologie et Nutrition du CHU de LIMOGES
name: Jérémie Jacques, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.