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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028133
Receipt No. R000032168
Scientific Title Clinical study for Robot-assisted partial nephrectomy with da Vinci Si
Date of disclosure of the study information 2017/08/01
Last modified on 2019/08/14

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Basic information
Public title Clinical study for Robot-assisted partial nephrectomy with da Vinci Si
Acronym Clinical study for Robot-assisted partial nephrectomy
Scientific Title Clinical study for Robot-assisted partial nephrectomy with da Vinci Si
Scientific Title:Acronym Clinical study for Robot-assisted partial nephrectomy
Region
Japan

Condition
Condition Renal Cell Carcinoma
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We examine the effectiveness and safety of Robot-ssited partial nephrectomy using daVinci Si system.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes intra-and postoperative complications and its contents
Key secondary outcomes Time of general anesthesia, operation time, bleeding, renal ischemic time, frequency of postoperative analgesic use, postoperative hospitalization period, perioperative renal function (before surgery (pre-operative surgery 12 weeks before),the day before surgery, on the day of the surgery, the day after surgery, the surgery three days after, the surgery six days later, after one month, three months after surgery)serum creatinine, eGFR), and before surgery (pre-operative surgery 12 weeks before), the day of one month, three months after surgery of renal scintigraphy), pathology findings

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Diagnosed with renal cell carcinoma and the clinical stage T1a (tumors less than 4 cm) N0M0 or T1b (diameter 4 cm to 7 cm), solitary tumors should be performed robot-assited partial nephrectomy under 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 with renal cell carcinoma and the clinical stage T1a (tumors less than 4 cm) N0M0 or T1b (diameter 4 cm to 7 cm), solitary tumors allows partial resection.
2. age of 20 years or more.
3. written informed consent obtained from the individual persons.
Key exclusion criteria 1. the patient seems to be difficult to surgery due to previous surgery.
2. activity of heavy multiple cancer among patients.
3.6 months undergoing treatment for kidney cancer.
4. patients with possible discontinuation of anticoagulants.
5. patients requiring blood transfusion anemia or tendency of bleeding.
6. morbid obesity (BMI35 or higher)
7. kidney transplantation history.
8. dialysis patients.
9. pregnant women or pregnant or lactating women
10. patients with a mental illness or psychiatric symptoms.
11. patients have serious complications (angina pectoris, myocardial infarction, serious arrhythmias, uncontrolled diabetes, malignant hypertension, etc.), surgical treatment is difficult.
12. patients who have renal dysfunction (serum creatinine values:1.5mg/dl more), liver function (AST, ALT:100IU/l).
13. patients with bacterial infections require treatment.
14. patients with interstitial Pneumonitis or pulmonary fibrosis.
15. patients with severe drug hypersensitivity, drug allergies.
16. patients with under 20 years old.
17. patient deemed unfit for this protocol.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Tomoaki
Middle name
Last name Miyagawa
Organization Jichi Medical University, Saitama Medical Center
Division name Department of Urology
Zip code 3308503
Address 1-847, Amanuma-cho, Omiya-ku, Saitama City, Saitama, Japan
TEL 048-647-2111
Email sh2-mya@jichi.ac.jp

Public contact
Name of contact person
1st name Tomoaki
Middle name
Last name Miyagawa
Organization Jichi Medical University, Saitama Medical Center
Division name Department of Urology
Zip code 3308503
Address 1-847, Amanuma-cho, Omiya-ku, Saitama City, Saitama, Japan
TEL 048-647-2111
Homepage URL
Email sh2-mya@jichi.ac.jp

Sponsor
Institute Jichi Medical University, Saitama Medical Center
Institute
Department

Funding Source
Organization Jichi Medical University, Saitama Medical Center
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 Jichi Medical University Saitama Medical Center
Address 1-847 Amanuma-cho Omiya-ku Saitama City Saitama Japan
Tel 0486472111
Email sh2-mya@jichi.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
2017 Year 08 Month 01 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 Enrolling by invitation
Date of protocol fixation
2017 Year 06 Month 01 Day
Date of IRB
2017 Year 06 Month 01 Day
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 07 Day
Last modified on
2019 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032168

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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