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In France in 2018, there were an estimated 2,074 new cases of esophageal adenocarcinoma and 3,224 cases of squamous cell carcinoma. The estimated deaths from esophageal cancer were 3,725, with a standardized 5-year net survival rate of 20% for cases diagnosed between 2010 and 2015, mainly due to late diagnosis.
Surgery was historically the standard treatment for localized disease but carries significant morbidity. Over the past decade, endoscopic treatments, particularly endoscopic submucosal dissection (ESD), have become the reference approach for superficial esophageal cancers.
After endoscopic resection, histological analysis allows classification of recurrence risk into very low, low, and high categories. Predicting lymph node or distant recurrence is complex, depending on factors such as depth of wall infiltration, lymphovascular invasion, and tumor differentiation. The frequent combination of unfavorable histological features may have led to an overestimation of lymph node involvement risk in T1b cancers.
ESD is widely performed in France, with over 1,600 procedures reported in 2023 for esophageal and gastric lesions, demonstrating the feasibility of a large observational study.
This multicenter French cohort will evaluate technical, oncological, and organizational outcomes of esophageal ESD, including overall survival, recurrence-free survival, and management of residual Barrett's esophagus. It will also identify predictive factors for treatment success, recurrence, and complications, providing real-world evidence to guide patient management.
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| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-free survival according to adjuvant treatment | Recurrence-free survival will be evaluated in patients after endoscopic submucosal dissection (ESD) of superficial esophageal carcinoma. Patients may receive adjuvant therapy (surgery, chemotherapy, or chemoradiotherapy) at the treating physician's discretion. Recurrence includes local, regional, or metastatic relapse as defined by clinical, endoscopic, and imaging criteria and validated by multidisciplinary team discussion. Recurrence will be monitored throughout the 5-year follow-up period to compare outcomes between patients receiving adjuvant therapy versus surveillance. | From enrollment to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | Proportion of patients with tumor-free lateral and deep margins confirmed by histopathology. | From ESD to 5 years |
| En bloc resection rate | Proportion of lesions resected in a single piece exclusively by ESD. |
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Inclusion Criteria:
Exclusion Criteria:
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Eligible patients include all individuals referred to a participating center for endoscopic resection of an esophageal lesion and treated by submucosal dissection. This is a prospective, multicenter, observational study, conducted on an intention-to-treat basis. All consecutive patients referred for esophageal ESD will be included.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bertrand BB BRIEAU, MD | Contact | +33650266383 | +33 | bertrand.brieau@gmail.com |
| Maira MORENO, PhD | Contact | +33(0)472117513 | rechercheclinique@sfed.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jules Verne Clinic | Nantes | 44300 | France |
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| ID | Term |
|---|---|
| C562730 | Adenocarcinoma Of Esophagus |
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| From ESD to 5 years |
| Curative resection rate | Proportion of R0 resections meeting favorable histological criteria: no lymphovascular invasion, no tumor budding, well-differentiated tumor, submucosal invasion <200 µm (squamous cell carcinoma) or <500 µm (adenocarcinoma). | From ESD to 5 years |
| 30-day complication rate | Rate of per- or post-procedural bleeding, immediate or delayed perforation, and strictures requiring endoscopic dilation. | 30 days post-ESD |
| Rate of MDTB presentation | Proportion of patients whose management was discussed in a multidisciplinary team meeting. | From ESD to 5 years |
| Concordance between MDTB decision and actual management | Proportion of patients for whom the implemented management matched the MDTB recommendation. | From ESD to 5 years |
| Rate of patients receiving adjuvant treatment | Proportion of patients receiving any adjuvant therapy after ESD (surgery, radiotherapy, chemotherapy, immunotherapy, etc.). | From enrollment to 5 years |
| Rate of complementary Barrett's eradication treatment (radiofrequency or other) | Proportion of patients treated for residual Barrett's esophagus using radiofrequency ablation or other endoscopic techniques. | From ESD to 5 years |
| Morbidity of complementary treatments | Rate of complications related to adjuvant therapy or Barrett's treatment | From ESD to 5 years |
| Efficacy of complementary treatments | Rate of complete remission of intestinal metaplasia or oncologic control following complementary tratmets | From complementary treatment to 5 years |
| Prognostic factors for recurrence (local, regional, metastatic) | Identification of clinical, endoscopic, and histological variables associated with increased risk of recurrence, analyzed using univariate and multivariate methods. | From enrollment to 5 years |
| Predictive factors for post-ESD complications | Analysis of factors associated with immediate or delayed complications (bleeding, perforation, stenosis) according to patient characteristics, ESD procedure, and adjuvant therapy. | From ESD to 5 years |
| Predictive factors for R0 resection | Analysis of clinical, endoscopic, and procedural variables predictive of complete R0 resection. | From ESD to 5 years |
| Diagnostic accuracy of optical endoscopic classifications vs. histology | Accuracy of endoscopic optical classifications in predicting histology prior to resection, compared to histopathology results. | From ESD to pathology report |
| Impact of center volume on outcomes | Evaluation of the influence of annual ESD procedure volume in a center on technical and oncologic outcomes | From enrollment to 5 years |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |