UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023545 |
|---|---|
| Receipt number | R000027118 |
| Scientific Title | Robot-Assisted Laparoscopic Parcial Nephrectomy for kidney cancer |
| Date of disclosure of the study information | 2016/08/08 |
| Last modified on | 2016/08/08 16:41:01 |
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Basic information
Public title
Robot-Assisted Laparoscopic Parcial Nephrectomy for kidney cancer
Acronym
Robot-Assisted Laparoscopic Parcial Nephrectomy for kidney cancer
Scientific Title
Robot-Assisted Laparoscopic Parcial Nephrectomy for kidney cancer
Scientific Title:Acronym
Robot-Assisted Laparoscopic Parcial Nephrectomy for kidney cancer
Region
| Japan |
Condition
Condition
kidney cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to analyze the outcome and safety of Robot-Assisted Laparoscopic Partial Nephrectomy for patients with small renal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Warm Ischemia Time
Key secondary outcomes
2-year recurrence-free survival rate
Complication rates
length of stay in hospital
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 |
Interventions/Control_1
Surgical Robot (Da Vinci Si)
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
(1) diagnosed as kidney cancer with indication for partial nephrectomy.
(2) aged 20 or over.
(3) signed written informed consent.
Key exclusion criteria
(1) severe mental disorder
(2) below age 20 years.
(3) severe respiratory disorder.
(4) hemorrhagic diathesis.
(5) severe diabetes mellitus.
(6) severe infectious disease
(7) judged as inappropriate by investigators.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Kawano |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Urology
Zip code
Address
1-1-1 Honjo, Chuo-ku, Kumamoto
TEL
096-373-5240
urology@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Kawano |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Urology
Zip code
Address
1-1-1 Honjo, Chuo-ku, Kumamoto
TEL
096-373-5240
Homepage URL
urology@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto University
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
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
熊本大学医学部附属病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 08 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 03 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Since 2015/10/01, lead principal investigator has been changed as below:
Masatoshi Eto -> Yoshiaki Kawano
Since 2015/09/02, Planned total case number has been changed as below:
5 cases -> 6 cases
Management information
Registered date
| 2016 | Year | 08 | Month | 08 | Day |
Last modified on
| 2016 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027118
