UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006969 |
|---|---|
| Receipt number | R000008228 |
| Scientific Title | mediastinoscope assited transhiatal esophagectomy with robotic surgery |
| Date of disclosure of the study information | 2012/01/07 |
| Last modified on | 2011/12/28 08:53:20 |
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Basic information
Public title
mediastinoscope assited transhiatal esophagectomy with robotic surgery
Acronym
robotic mediastinoscope assited transhiatal esophagectomy
Scientific Title
mediastinoscope assited transhiatal esophagectomy with robotic surgery
Scientific Title:Acronym
robotic mediastinoscope assited transhiatal esophagectomy
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety of the operation
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Safety of the operation
Key secondary outcomes
Efficacy of the operation
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) esophageal cancer
2) good physical status
3) tolerable for general anesthesia
Key exclusion criteria
1) serious complications
2) serious adhesion
3) refuse for operation
4) Doctor's decision
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Tangoku |
Organization
Tokushima University Hospital
Division name
Department of esophageal, breast and thyroid disease
Zip code
Address
Kuramoto 2-50-1
TEL
088-633-3111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Tangoku |
Organization
Tokushima University Hospital
Division name
Department of esophageal, breast and thyroid disease
Zip code
Address
Kuramoto 2-50-1
TEL
088-633-3111
Homepage URL
http://www.tksbizan.com/
surgery2@clin.med.tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokushima University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2012 | Year | 01 | Month | 07 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Robotic syrgery with DaVinch S system
Management information
Registered date
| 2011 | Year | 12 | Month | 28 | Day |
Last modified on
| 2011 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008228
