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Clinical Trials/JPRN-jRCT1040220153
JPRN-jRCT1040220153
Recruiting
Phase 2

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

Takeuchi Hiroya0 sites90 target enrollmentFebruary 28, 2023
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Takeuchi Hiroya
Enrollment
90
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 28, 2023
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Takeuchi Hiroya

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Not specified

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