UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Robot-Assisted Laparoscopic Parcial Nephrectomy for kidney cancer
Title of the study (Brief title)	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	Yoshiaki Kawano
Organization	Faculty of Life Sciences, Kumamoto University
Division name	Department of Urology
Address	1-1-1 Honjo, Chuo-ku, Kumamoto
TEL	096-373-5240
Email	urology@kumamoto-u.ac.jp

Public contact
Name of contact person	Yoshiaki Kawano
Organization	Faculty of Life Sciences, Kumamoto University
Division name	Department of Urology
Address	1-1-1 Honjo, Chuo-ku, Kumamoto
TEL	096-373-5240
Homepage URL
Email	urology@kumamoto-u.ac.jp

Sponsor
Institute	Kumamoto University
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 03 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027118