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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,200
Endoscopic submucosal dissection
CHU d'Amiens
Amiens, France
RECRUITINGClinique de l'Anjou
Angers, France
RECRUITINGCHU de Besançon
Besançon, France
RECRUITINGCHU de Bordeaux
Bordeaux, France
RECRUITINGCHRU de Brest
Brest, France
RECRUITINGCHU de Dijon
Dijon, France
RECRUITINGCHU de Limoges
Limoges, France
RECRUITINGHopital Edouard Herriot
Lyon, France
RECRUITINGHôpital Jean Mermoz
Lyon, France
RECRUITINGHôpital Européen
Marseille, France
RECRUITING...and 15 more locations
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 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 6
Monobloc resection rate
Monobloc resection is defined as resection of the lesion in a single piece.
Time frame: Day 1
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 1
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 1
Optimal dissection rate
Optimal dissection is defined as exclusive R0 dissection without perforation, with a resection speed \> 20 mm2/min.
Time frame: Month 1
30-day complication rate
* Per-procedural perforation: breach of the colonic musculature with visualization of the peritoneal cavity. * Post-procedural perforation (≤ 30 days): abdominal pain associated with fever or inflammatory syndrome and presence of extraluminal air on abdominal-pelvic CT scan, in the absence of per-procedural perforation. * Per-procedural hemorrhage: considered a complication only if it leads to interruption of the procedure. * Post-procedural hemorrhage: rectal bleeding or melena requiring hospitalization (or prolonged hospitalization) or endoscopic hemostasis.
Time frame: Month 1
Curative endoscopic resection rate without surgical management at 36 months
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
Number of metachronous colorectal lesions at 36 months
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
Surgery rate at 36 months
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 rate at 36 months
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 36
Effectiveness of histological prediction of superficial colorectal lesions treated according to the technological tools used.
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
Impact of center volume on oncological outcomes, technical outcomes, and procedural complications.
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
Compare oncological and technical outcomes and procedural complications based on colonic or rectal location.
Oncological, technical, and complication outcomes will be analyzed according to the colonic or rectal location of the lesion.
Time frame: Month 1
Compare procedural outcomes based on the different traction strategies used
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: Month 1
Analyze the learning curve of new trainees at the time of implementation of the submucosal dissection curriculum of the French Society of Digestive Endoscopy.
The learning curve of trainees will be used to evaluate oncological, technical, and complication outcomes using the LC CUSUM method.
Time frame: statitistic analysis
Creation of a difficulty score predicting the success of ESD (R0 resection without perforation)
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.
Time frame: Month 1
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