UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039362 |
|---|---|
| Receipt number | R000044886 |
| Scientific Title | A prospective safety and efficacy study of robotic thoracic esophagectomy for esophageal cancer |
| Date of disclosure of the study information | 2020/08/02 |
| Last modified on | 2023/03/09 15:26:12 |
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Basic information
Public title
A prospective safety and efficacy study of robotic thoracic esophagectomy for esophageal cancer
Acronym
A prospective safety and efficacy study of robotic thoracic esophagectomy for esophageal cancer
Scientific Title
A prospective safety and efficacy study of robotic thoracic esophagectomy for esophageal cancer
Scientific Title:Acronym
A prospective safety and efficacy study of robotic thoracic esophagectomy for esophageal cancer
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate safety and efficacy of robotic thoracic esophagectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The incidence rate of recurrent nerve palsy
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who undergo robotic thoracic esophagectomy
Key exclusion criteria
Patients who are not eligible to participate in the study (by decision of the investigators).
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Nagino |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology, Department of Surgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aich, Japan
TEL
0527442222
nagino@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazushi |
| Middle name | |
| Last name | Miyata |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology, Department of Surgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aich, Japan
TEL
052-744-2222
Homepage URL
kmiyata@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aich, Japan
Tel
0527412111
ethics@med.nagoya-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective observational study to verify the incidence rate of recurrent nerve palsy in robot-assisted esophagectomy.
Management information
Registered date
| 2020 | Year | 02 | Month | 02 | Day |
Last modified on
| 2023 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044886
