UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018909 |
|---|---|
| Receipt number | R000021881 |
| Scientific Title | Robot-assisted laparoscopic pancreatoduodenectomy using the da Vinci S for pancreatic-biliary tract tumor. |
| Date of disclosure of the study information | 2015/09/04 |
| Last modified on | 2015/09/04 13:02:46 |
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Basic information
Public title
Robot-assisted laparoscopic pancreatoduodenectomy using the da Vinci S for pancreatic-biliary tract tumor.
Acronym
Robot-assisted laparoscopic pancreatoduodenectomy using the da Vinci S.
Scientific Title
Robot-assisted laparoscopic pancreatoduodenectomy using the da Vinci S for pancreatic-biliary tract tumor.
Scientific Title:Acronym
Robot-assisted laparoscopic pancreatoduodenectomy using the da Vinci S.
Region
| Japan |
Condition
Condition
pancreatic-biliary tract tumor
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the safety and usefulness of surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complication rate, mortality and tumor prognosis of surgery patients
Key secondary outcomes
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with surgical indication of pancreaticobiliary road tumor
Key exclusion criteria
Patients without surgical indication of pancreaticobiliary road tumor
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Maehara |
Organization
Kyushu University
Division name
Department of Surgery and Science, Graduate School of Medical Sciences,
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5461
maehara@surg2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuo Ikeda |
Organization
Kyushu University Hospital
Division name
Center for Integration of Advanced Medicine and Innovative Technology
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5992
Homepage URL
t-ikeda@surg2.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
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
| 2015 | Year | 09 | Month | 04 | 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
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In selecting a compatible case
Management information
Registered date
| 2015 | Year | 09 | Month | 04 | Day |
Last modified on
| 2015 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021881
