UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009727 |
|---|---|
| Receipt number | R000011401 |
| Scientific Title | Efficacy and safety of robotic assisted thoracoscopic esophagectomy and mediastinal lymphadenectomy using the da Vinci surgical system for thoracic esophageal cancer |
| Date of disclosure of the study information | 2013/01/10 |
| Last modified on | 2013/01/08 17:13:36 |
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Basic information
Public title
Efficacy and safety of robotic assisted thoracoscopic esophagectomy and mediastinal lymphadenectomy using the da Vinci surgical system for thoracic esophageal cancer
Acronym
Robotic assisted thoracoscopic esophagectomy and mediastinal lymphadenectomy
Scientific Title
Efficacy and safety of robotic assisted thoracoscopic esophagectomy and mediastinal lymphadenectomy using the da Vinci surgical system for thoracic esophageal cancer
Scientific Title:Acronym
Robotic assisted thoracoscopic esophagectomy and mediastinal lymphadenectomy
Region
| Japan |
Condition
Condition
Thoracic esophageal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The object is to evaluate the efficacy and safety of robotic assisted esphagectomy and mediastinal lymphadenectomy using the da Vinci surgical system for thoracic esophageal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
completion rate of the robotic assisted surgery
total adverse event rate
Key secondary outcomes
duration of operation
intraoperative blood loss
incidence of a recurrent nerve palsy
length of postoperative hospital stay
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
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
Introduce a robotic assisted thoracoscopic esophagectomy and mediastinal lymphadenectomy for resectable thoracic esophageal cancer patients.
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
resectable thoracic esophageal cancer
Key exclusion criteria
patient with a history of an intrathoracic surgery
patient with an esophago-bronchial fistulae
in case of an emergency operation
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Kamei |
Organization
Tohoku University Hospital
Division name
Division of transplantation, reconstruction and endoscopic surgery
Zip code
Address
1-1 Seiryo-chou, Aoba-ku, Sendai, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Kamei |
Organization
Tohoku University Hospital
Division name
Division of transplantation, reconstruction and endoscopic surgery
Zip code
Address
TEL
Homepage URL
tkamei@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tohoku University 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
| 2013 | Year | 01 | Month | 10 | 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
| 2013 | Year | 01 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 08 | Day |
Last modified on
| 2013 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011401
