Prospective Multicenter Cohort on Esophageal Submucosal Dissection: Evaluation of Technical, Oncological, and Organizational Outcomes in Real-Life Practice
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Recurrence-free survival according to adjuvant treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥ 18 years old)
- •Patients referred for endoscopic resection of an esophageal lesion and treated by submucosal dissection
- •Patients managed in one of the participating centers
- •Patient who has received oral and written information about the study and has not objected to participation
- •Patients covered by a social security or health insurance scheme.
排除标准
- •Patient refusal after reading the information sheet
- •Patient under legal protection (guardianship, curatorship, court-ordered protection)
- •Inability to inform the patient due to cognitive impairment, language barrier, or medical emergency
- •Patients previously included for another lesion in the same study
- •Pregnant or breastfeeding women.
- •Patient deprived of liberty.
- •Patient currently enrolled in another clinical trial.
结局指标
主要结局
Recurrence-free survival according to adjuvant treatment
时间窗: From enrollment to 5 years
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.
次要结局
- R0 resection rate(From ESD to 5 years)
- En bloc resection rate(From ESD to 5 years)
- Curative resection rate(From ESD to 5 years)
- 30-day complication rate(30 days post-ESD)
- Rate of MDTB presentation(From ESD to 5 years)
- Concordance between MDTB decision and actual management(From ESD to 5 years)
- Rate of patients receiving adjuvant treatment(From enrollment to 5 years)
- Rate of complementary Barrett's eradication treatment (radiofrequency or other)(From ESD to 5 years)
- Morbidity of complementary treatments(From ESD to 5 years)
- Efficacy of complementary treatments(From complementary treatment to 5 years)
- Prognostic factors for recurrence (local, regional, metastatic)(From enrollment to 5 years)
- Predictive factors for post-ESD complications(From ESD to 5 years)
- Predictive factors for R0 resection(From ESD to 5 years)
- Diagnostic accuracy of optical endoscopic classifications vs. histology(From ESD to pathology report)
- Impact of center volume on outcomes(From enrollment to 5 years)
研究者
Bertrand Brieau
Principal Investigator, Medical doctor
Société Française d'Endoscopie Digestive