跳至主要内容
临床试验/NL-OMON25137
NL-OMON25137已完成不适用

Tailored lymphadenectomy using Sentinel node Navigation surgery in submucosal esophageal Adenocarcinoma Patients: SNAP-III study

niversity Medical Center Utrecht0 个研究点目标入组 10 人开始时间: 待定最近更新:
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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