Endoscopic submucosal dissection
ProcedureEndoscopic submucosal dissection
NCT Number: NCT04592003
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
CHU d'Amiens, Amiens, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Endoscopic submucosal dissection
Time frame: Month 1
R0 Resection rate according to the definition of of the European Society of Gastrointestinal Endoscopy.
Time frame: Month 6
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: Day 1
Monobloc resection is defined as resection of the lesion in a single piece.
Time frame: Day 1
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: Month 1
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 1
Optimal dissection is defined as exclusive R0 dissection without perforation, with a resection speed > 20 mm2/min.
Time frame: Month 1
Time frame: Month 36
Curative endoscopic resection without surgery is defined by the absence of adenoma or adenocarcinoma at the resection scar after 36 months of follow-up, regardless of the number of endoscopic treatments required.
Time frame: Month 36
A metachronous lesion is defined as the presence of a new superficial colorectal lesion during one of the endoscopic checks, a lesion not visualized during one of the previous examinations.
Time frame: Month 36
Any colorectal surgery will be taken into account, whether due to failure of the endoscopic procedure, recurrence, a complication of the procedure, or an anatomopathological reason.
Time frame: Month 36
Recurrence at 36 months 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 1
The histological prediction of resected lesions will be established using validated classifications (Paris, SANO, NICE, KUDO, JNET, CONECTT). It will be compared with the definitive histological results to assess their sensitivity, specificity, and diagnostic accuracy within the cohort.
Time frame: Month 1
Oncological, technical, and complication outcomes will be analyzed according to the annual volume of the centers (low volume = < 50 ESDs per year; intermediate volume = between 50 and 100 procedures per year; high volume = > 100 procedures per year).
Time frame: Month 1
Oncological, technical, and complication outcomes will be analyzed according to the colonic or rectal location of the lesion.
Time frame: Month 1
Oncological, technical, and complication outcomes will be analyzed according to the traction system used for the procedure, matching lesions according to difficulty criteria validated by the literature.
Time frame: statitistic analysis
The learning curve of trainees will be used to evaluate oncological, technical, and complication outcomes using the LC CUSUM method.
Time frame: Month 1
A difficulty score predicting success (R0 without perforation) will be created by performing a multivariate analysis according to the TRIPOD GUIDELINES using a derivation cohort and validated on a derivation cohort.
Contact information is provided by the study sponsor or research team.
Juge Sandra, Dr
CONTACT
Jérémie Jacques, Pr
CONTACT
University Hospital, Limoges
Other
Acronym: FECCo
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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