UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A retrospective Multicenter Study to Assess the Safety and Efficacy of Robot-assisted (da Vinci surgical system, DVSS) Partial Nephrectomy for small renal tumors.
Title of the study (Brief title)	A retrospective Multicenter Study to Assess the Safety and Efficacy of Robot-assited Partial Nephrectomy
Region	Japan

Condition
Condition	Small renal tumors
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the safety and efficacy of robot-assisted (da Vinci surgical system, DVSS) partial nephrectomy for small renal tumors performed at multi-institutions in Japan.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	- Oncological outcome: margin status, recurrence-free survival - Renal function: Warm ischemia time, serum creatinine, eGFR - Safety outcomes:Adverse Events - Other outcomes: Operative Time, Blood Loss
Key secondary outcomes	- Assessment of factors that affect post-operative kidney function - Assessment of learning curves for robot-assisted partial nephrectomy - Assessment of changes of pre- and post- operative eGFR

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with small renal tumors who received Robot-assisted partial nephrectomy between January 2011 and March 2016
Key exclusion criteria	Patients who deny the enrollment of this study
Target sample size	900

Research contact person
Name of lead principal investigator	Masato Fujisawa
Organization	Kobe University Graduate School of Medicine
Division name	Division of Urology, Department of Surgery Related
Address	7-5-2, Kusunokicho, Chuoku, Kobe, 650-0017, Japan
TEL	078-382-6155
Email	uro6155@med.kobe-u.ac.jp

Public contact
Name of contact person	Junya Furukawa
Organization	Kobe University Graduate School of Medicine
Division name	Division of Urology, Department of Surgery Related
Address	7-5-2, Kusunokicho, Chuoku, Kobe, 650-0017, Japan
TEL	078-382-6155
Homepage URL
Email	uro6155@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Graduate School of Medicine Division of Urology, Department of Surgery Related
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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	神戸大学医学部附属病院を含め約60施設

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 20 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 05 Month 06 Day
Anticipated trial start date	2016 Year 06 Month 20 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	none

Management information
Registered date	2016 Year 12 Month 20 Day
Last modified on	2016 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029152