Cancer Colorectal, Endoscopic Submucosal Resection, Polyps Colorectal
Conditions
Keywords
Cancer colorectal, Polyps colorectal, Endoscopic submucosal resection
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. The aim of this French multicenter cohort is to analyze the results of colorectal submucosal dissection on a large scale.
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. The aim of this French multicenter cohort is to analyze the results of colorectal submucosal dissection on a large scale.
Interventions
PROCEDUREEndoscopic submucosal dissection
Endoscopic submucosal dissection
Sponsors
University Hospital, Limoges
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| R0 Resection rate of submucosal dissection for superficial colorectal lesions | Month 1 | R0 Resection rate according to the definition of of the European Society of Gastrointestinal Endoscopy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monobloc resection rate | Day 1 | Monobloc resection is defined as resection of the lesion in a single piece. |
| Monobloc resection rate exclusively in ESD. | 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). |
| Curative resection rate | 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). |
| Optimal dissection rate | Month 1 | Optimal dissection is defined as exclusive R0 dissection without perforation, with a resection speed \> 20 mm2/min. |
| Number of metachronous colorectal lesions at 36 months | 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. |
| Surgery rate at 36 months | 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. |
| 30-day complication rate | Month 1 | * 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. |
| Endoscopic recurrence rate during the first endoscopic follow-up | 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. |
| Recurrence rate at 36 months | 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. |
| Effectiveness of histological prediction of superficial colorectal lesions treated according to the technological tools used. | 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. |
| Impact of center volume on oncological outcomes, technical outcomes, and procedural complications. | 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). |
| Compare oncological and technical outcomes and procedural complications based on colonic or rectal location. | Month 1 | Oncological, technical, and complication outcomes will be analyzed according to the colonic or rectal location of the lesion. |
| Compare procedural outcomes based on the different traction strategies used | 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. |
| Analyze the learning curve of new trainees at the time of implementation of the submucosal dissection curriculum of the French Society of Digestive Endoscopy. | statitistic analysis | The learning curve of trainees will be used to evaluate oncological, technical, and complication outcomes using the LC CUSUM method. |
| Creation of a difficulty score predicting the success of ESD (R0 resection without perforation) | 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. |
| Curative endoscopic resection rate without surgical management at 36 months | 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. |
Countries
France
Contacts
Primary ContactJérémie Jacques, Pr
Backup ContactJuge Sandra, Dr
Outcome results
None listed