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临床试验/JPRN-jRCT1040220153
JPRN-jRCT1040220153招募中2 期

A randomized controlled phase 2 trial comparing the safety and usefulness of robot-assisted esophagectomy and thoracoscopic - ROBOCOP

Takeuchi Hiroya0 个研究点目标入组 90 人开始时间: 2023年2月28日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
90

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

年龄范围
>= 18age old 至 ot applicable(—)
性别
All

入选标准

  • Intended for patients who meet all of the following criteria
  • 1.Patients over 18 years old
  • 2. Patients diagnosed with esophageal or gastroesophageal junction cancer
  • 3. Patients scheduled for subtotal thoracic esophagectomy with bilateral recurrent laryngeal perineural lymph node (#106recR and #106recL) dissection
  • 4. Those who have obtained consent to participate in this research by signing a consent form by themselves or their proxy

排除标准

  • Patients who meet any of the following conditions will not be included in this study.
  • 1. Subjects with recurrent laryngeal nerve palsy before surgery
  • 2. Patients with heart disease (NYHA III-IV, severe arrhythmia)
  • 3. Subjects with severe liver disorder (fulminant hepatitis, hepatic encephalopathy, Child-Pugh classification Grade C)
  • 4. Subjects with severe renal impairment (chronic kidney disease stage 4 or 5 according to CKD guidelines)
  • 5. Women who are pregnant or may become pregnant
  • 6. breastfeeding woman
  • 7. Subjects with dementia
  • 8. Those judged inappropriate by the investigator

研究者

发起方
Takeuchi Hiroya

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