NL-OMON25137已完成不适用
Tailored lymphadenectomy using Sentinel node Navigation surgery in submucosal esophageal Adenocarcinoma Patients: SNAP-III study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1)High-risk submucosal EAC on histology (diagnosed in ER specimen) confirmed by an expert gastrointestinal pathologist, defined as:
- •a) Infiltration of EAC into the deep submucosa (>500 µm), and/or;
- •b) Poor differentiation (G3) or undifferentiated (G4) EAC, and/or;
- •c) Presence of lymphovascular invasion
- •2)Tumor-free deep vertical resection margins in the ER specimen
- •3)Clinically staged as T1N0M0
- •4)Fit for endoscopy and surgery per institution’s standards
- •5)Older than 18 years of age at time of informed consent
- •6)Willing and able to comply with follow-up requirements
- •7)Written informed consent
排除标准
- •1)History of esophageal squamous cell carcinoma
- •2)Clinically staged as N+
- •3)Prior neoadjuvant chemoradiation therapy
- •4)Prior esophageal surgery interfering with the procedure
- •5)Other primary tumor with a life-expectancy less than 3 years
- •6)Known allergy for the radioactive tracer (technetium) or dye (indocyanine green)
- •7)Severe medical comorbidities precluding endoscopy and/or surgery
- •8)Pregnant or planning to become pregnant during period of study
- •9)Refusing or unable to provide written informed consent
- •10)Participation in another study within the 30 days preceding or during the present study, interfering with participation in the current study
研究者
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