UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020708 |
|---|---|
| Receipt number | R000023895 |
| Scientific Title | Efficacy and safety of robot assisted partial nephrectomy for renal cell carcinoma |
| Date of disclosure of the study information | 2016/01/25 |
| Last modified on | 2016/01/23 11:44:45 |
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Basic information
Public title
Efficacy and safety of robot assisted partial nephrectomy for renal cell carcinoma
Acronym
Efficacy and safety of RAPN
Scientific Title
Efficacy and safety of robot assisted partial nephrectomy for renal cell carcinoma
Scientific Title:Acronym
Efficacy and safety of RAPN
Region
| Japan |
Condition
Condition
renal cell carcinoma (cT1N0M0)
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
cancer control and preservation of renal function
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
radical resection, preservation of renal function, and safety (pathological data, ischemic time and conversion to open surgery)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
laparoscopic partial nephrectomy using da Vinci surgical system (DVSS)
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.cT1 renal cell carcinoma clinically diagnosed and a partial nephrectomy is appropriate.
2.Written informed consent is obtained
Key exclusion criteria
1.Multiple cancer
2.Unable to withdraw of anticoagulation
3.Unable to make position due to lumber diagnosis or others
4.High risk for anesthesia or surgery due to comorbidity
5.Difficult due to previous surgery
6.Obesity (BMI>35)
7.Difficult to participate the study due to psychiatric disorder or cognitive deficiency
8.Inappropriate by the investigator for any other reasons
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noboru Nakaigawa |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Urology
Zip code
Address
3-9 Fukuura, Kanazawaku, Yokohama, 236-0004, Japan
TEL
045-787-2679
nakaigan@ymed.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noboru Nakaigawa |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Urology
Zip code
Address
3-9 Fukuura, Kanazawaku, Yokohama, 236-0004, Japan
TEL
045-787-2679
Homepage URL
nakaigan@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
Organization
Division
Category of Funding Organization
Local Government
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
| 2016 | Year | 01 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 11 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 23 | Day |
Last modified on
| 2016 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023895
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
