UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Robot assisted partial nephrectomy for renal cell carcinoma
Title of the study (Brief title)	Robot assisted partial nephrectomy for renal cell carcinoma
Region	Japan

Condition
Condition	renal cell carcinoma
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the feasibility and safety of robot assisted partial nephrectomy for renal cell carcinoma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Preservation of renal function and curability of renal cell carcinoma.
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	Partial nephrectomy using Da Vinci Si surgical system.
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 2) cT1 renal cell carcinoma diagnosed by CT or MRI and can be resected partially. 3) cN0, cM0 4) No lung metastasis 5) Solitary tumor 6) Meet all below criteria I. WBC greater than 3000/uL II. Plt greater than 10000 /uL III. AST less than 100 IU/L IV. ALT less than 100 IU/L V. T.Bil less than 2.0 mg/dL 7) Age greater than 20 8) Informed consent
Key exclusion criteria	1) Not applicable for partial nephrectomy 2) Metastasis 3) Other cancer 4) Undergoing renal transplantation 5) HD 6) Impossible to discontinue anti-coagulant 7) BMI over 35 8) Pregnancy 9) Psychological disorder 10) Other reason
Target sample size	10

Research contact person
Name of lead principal investigator	Norio Nonomura
Organization	Osaka University Graduate School of Medicine
Division name	Urology
Address	2-2 Yamadaoka, Suita
TEL	06-6879-3531
Email	nono@uro.med.osaka-u.ac.jp

Public contact
Name of contact person	Hiroshi Kiuchi
Organization	Osaka University Graduate School of Medicine
Division name	Urology
Address	2-2 Yamadaoka, Suita
TEL	06-6879-3531
Homepage URL
Email	kiuchi@uro.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
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	2016 Year 01 Month 21 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 01 Month 07 Day
Anticipated trial start date	2016 Year 02 Month 01 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	2016 Year 01 Month 20 Day
Last modified on	2017 Year 01 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023812