UMIN-CTR Clinical Trial

Basic information
Public title	Study for efficacy and safety of robot-assisted partial nephrectomy using Da Vinci surgical system
Acronym	Efficacy and safety of RAPN
Scientific Title	Study for efficacy and safety of robot-assisted partial nephrectomy using Da Vinci surgical system
Scientific Title:Acronym	Efficacy and safety of RAPN
Region	Japan

Condition
Condition	Patients with renal cell carcinoma who are undergoing partial nephrectomy
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Duration of surgery, worm ischemic time, surgical complications, histology of surgical specimens, and postoperative outcome will be evaluated for assessment of utility and safety of RAPN.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Worm ischemic time of renal artery, perioperative and postoperative complications, histology of surgical specimen, postoperative renal function
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 Maneuver
Interventions/Control_1	Partial nephrectomy will be performed by full robot-assisted procedure using Da Vinci surgical system. It will take approximately 4 hours and blood loss will be 150 mL.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Diagnosed as renal tumor by imaging analysis Clinical stage of T1aN0M0 (tumor diameter is equal or smaller than 4 cm) Informed consent is obtained from the patient
Key exclusion criteria	Active other malignancy Other treatment within 6 months Severe heart disease Severe hepatic disease Anti-coagulant therapy cannot stop Sever obesity such as BMI > 35 Patients without informed consent Any other reasons inappropriate for this study
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Toru Middle name Last name Shimazui
Organization	Ibaraki Prefectural Central Hospital
Division name	Department of Urology
Zip code	309-1793
Address	6528 Koibuchi, Kasama, Ibaraki 309-1793, Japan
TEL	0296-77-1121
Email	torushim@md.tsukuba.ac.jp

Public contact
Name of contact person	1st name Atsushi Middle name Last name Yamauchi
Organization	Ibaraki Prefectural Central Hospital
Division name	Department of Urology
Zip code	309-1793
Address	6528 Koibuchi, Kasama, Ibaraki 309-1793, Japan
TEL	0296-77-1121
Homepage URL
Email	at-yamauchi@chubyoin.pref.ibaraki.jp

Sponsor
Institute	Ibaraki Prefectural Central Hospital
Institute
Department

Funding Source
Organization	Ibaraki Prefectural Central Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB of Ibaraki Prefectural Central Hospital
Address	6528 Koibuchi, Kasama, Ibaraki, Japan
Tel	0296-77-1121
Email	h-oyama@chubyoin.pref.ibaraki.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	2015 Year 09 Month 24 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	5
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	Completed
Date of protocol fixation	2014 Year 12 Month 05 Day
Date of IRB	2014 Year 11 Month 26 Day
Anticipated trial start date	2015 Year 03 Month 01 Day
Last follow-up date	2020 Year 02 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 09 Month 17 Day
Last modified on	2020 Year 03 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022034