French Colorectal ESD Cohort in Experts Centers
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Limoges
About this trial
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.
The aim of this French multicenter cohort is to analyze the results of colorectal submucosal dissection on a large scale.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
All patients addressed for a colorectal ESD
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Endoscopic submucosal dissection
Procedure/SurgeryEndoscopic submucosal dissection
Treatment groups
1,200 Participants
are divided into 1 treatment groupGroup A: FECCo : French Esd Colorectal Cohort in Experts Centers1 intervention
Trial outcomes
Primary outcomes
1
R0 Resection rate of submucosal dissection for superficial colorectal lesions
R0 Resection rate according to the definition of of the European Society of Gastrointestinal Endoscopy.
Time frame
Month 1Secondary outcomes
1
Endoscopic recurrence rate during the first endoscopic follow-up
Recurrence during the first endoscopic follow-up will be defined by the presence of adenoma or adenocarcinoma at the resection scar, whether visible or not, and confirmed by systematic biopsies of the resection scar.
Time frame
Month 62
Monobloc resection rate
Monobloc resection is defined as resection of the lesion in a single piece.
Time frame
Day 13
Monobloc resection rate exclusively in ESD.
Monobloc resection exclusively by ESD is defined as resection of the lesion in a single piece using submucosal dissection only, without the use of a diathermic loop (hybrid technique).
Time frame
Day 14
Curative resection rate
Curative resection is defined according to the recommendations of the European Society of Digestive Endoscopy as a monobloc R0 dissection without any negative anatomopathological criteria (well-differentiated lesion, no emboli, no budding \> 1, submucosal infiltration \< 1 mm).
Time frame
Month 1Sponsors and contacts
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Source ClinicalTrials.gov