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.
Study Type
OBSERVATIONAL
Enrollment
750
Jules Verne Clinic
Nantes, France
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.
Time frame: From enrollment to 5 years
R0 resection rate
Proportion of patients with tumor-free lateral and deep margins confirmed by histopathology.
Time frame: From ESD to 5 years
En bloc resection rate
Proportion of lesions resected in a single piece exclusively by ESD.
Time frame: 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).
Time frame: 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.
Time frame: 30 days post-ESD
Rate of MDTB presentation
Proportion of patients whose management was discussed in a multidisciplinary team meeting.
Time frame: From ESD to 5 years
Concordance between MDTB decision and actual management
Proportion of patients for whom the implemented management matched the MDTB recommendation.
Time frame: 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.).
Time frame: 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.
Time frame: From ESD to 5 years
Morbidity of complementary treatments
Rate of complications related to adjuvant therapy or Barrett's treatment
Time frame: From ESD to 5 years
Efficacy of complementary treatments
Rate of complete remission of intestinal metaplasia or oncologic control following complementary tratmets
Time frame: 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.
Time frame: 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.
Time frame: From ESD to 5 years
Predictive factors for R0 resection
Analysis of clinical, endoscopic, and procedural variables predictive of complete R0 resection.
Time frame: 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.
Time frame: 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
Time frame: From enrollment to 5 years
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