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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033306
Receipt No. R000036144
Official scientific title of the study 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 2018/07/06

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Basic information
Official scientific title of the study A study examining the safety and efficacy of robot-assisted surgery using the da Vinci Si system for patients with biliary dilation
Title of the study (Brief title) 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 Atsuyuki Yamataka
Organization Juntendo University
Division name Pediatric Surgery
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email yama@juntendo.ac.jp

Public contact
Name of contact person Hiroshi Murakami
Organization Juntendo University
Division name Pediatric Surgery
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email hmuraka@juntendo.ac.jp

Sponsor
Institute Pediatric Genaral and Urogenital Surgery, Juntendo University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 07 Month 03 Day
Anticipated trial start date
2017 Year 07 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 06 Day
Last modified on
2018 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036144

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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