UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033306 |
|---|---|
| Receipt number | R000036144 |
| Scientific Title | A study examining the safety and efficacy of robot-assisted surgery using the da Vinci Si system for patients with biliary dilation |
| Date of disclosure of the study information | 2018/07/06 |
| Last modified on | 2019/06/14 11:26:35 |
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Basic information
Public title
A study examining the safety and efficacy of robot-assisted surgery using the da Vinci Si system for patients with biliary dilation
Acronym
A study examining the safety and efficacy of robot-assisted surgery using the da Vinci Si system for patients with biliary dilation
Scientific Title
A study examining the safety and efficacy of robot-assisted surgery using the da Vinci Si system for patients with biliary dilation
Scientific Title:Acronym
A study examining the safety and efficacy of robot-assisted surgery using the da Vinci Si system for patients with biliary dilation
Region
| Japan |
Condition
Condition
biliary dilation
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The long-term goal of the study is to submit an application for advanced medicine regarding the use of the da Vinci surgical system for robot-assisted surgery for biliary dilation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative follow-up, including the incidence and change in the status of pancreatitis.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Laparoscopic Group
Interventions/Control_2
Robotic group
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
| 1 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Congenital biliary dilatation patients, who needs operation.
Key exclusion criteria
None.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Atsuyuki |
| Middle name | |
| Last name | Yamataka |
Organization
Juntendo University
Division name
Pediatric Surgery
Zip code
1138421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
yama@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Murakami |
Organization
Juntendo University
Division name
Pediatric Surgery
Zip code
1138421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
hmuraka@juntendo.ac.jp
Sponsor or person
Institute
Pediatric Genaral and Urogenital Surgery, Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Hospital Ethics Committee Juntendo University Hospital
Address
3-1-3,Hongo,Bunkyo-ku,Tokyo
Tel
03-3813-3111
kenkyu5858@juntendo.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
| 2018 | Year | 07 | Month | 06 | 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
10
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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 06 | Day |
Last modified on
| 2019 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036144
