UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007450 |
|---|---|
| Receipt number | R000008769 |
| Scientific Title | Robotic assisted mediatinoscopic subtotal esophagectomy and three-field dissection for esophageal cancer |
| Date of disclosure of the study information | 2012/03/06 |
| Last modified on | 2022/03/14 21:04:39 |
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Basic information
Public title
Robotic assisted mediatinoscopic subtotal esophagectomy and three-field dissection for esophageal cancer
Acronym
Robotic assisted transhiatal radical esophagectomy
Scientific Title
Robotic assisted mediatinoscopic subtotal esophagectomy and three-field dissection for esophageal cancer
Scientific Title:Acronym
Robotic assisted transhiatal radical esophagectomy
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish a radical surgery without thoracotomy for esophageal cancer by applying a robotic surgery system (da Vinci S) for mediastinoscopic operative field.
To demonstrate the safety, oncological equality and minimal invasiveness of the newly developed surgery compared to the comventional surgery
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
intraoperative blood loss
duration of operation
surgical morbidity
Key secondary outcomes
number of harvested lymph nodes
length of postoperative hospital stay
disease free survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
From approval to the 31st, March/2014
Non thoracic, transhiatal esophagectomy with three-field radical lymphadenectomy for esophageal cancer
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Curable thoracic esophageal and/or gastroesophageal junctional cancer
Key exclusion criteria
Tumor invading adjacent organ
Prior chemoradiotherapy
Abnormal laboratory findings (CRP>10,WBC>15000)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Seto |
Organization
the University of Tokyo Hospital
Division name
Gastrointestinal Surgery
Zip code
Address
7-3-1Hongo, Bunkyo-ku Tokyo,JPN
TEL
03-3815-5411
seto-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Mori |
Organization
the University of Tokyo Hospital
Division name
Gastrointestinal Surgery
Zip code
Address
7-3-1Hongo, Bunkyo-ku Tokyo
TEL
03-3815-5411
Homepage URL
morikaz158@gmail.com
Sponsor or person
Institute
the University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
the University of Tokyo Hospital
Organization
Division
Category of Funding Organization
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 | 03 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://onlinelibrary.wiley.com/doi/10.1111/dote.12345/full
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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2011 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 05 | Day |
Last modified on
| 2022 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008769
