UMIN-CTR Clinical Trial

Basic information
Public title	Un-blinded Multicenter Study to Assess the Safety of Robotic-assisted (da Vinci surgical system, DVSS) Laparoscopic Partial Nephrectomy for Hilar Tumors
Acronym	Un-blinded Multicenter Study to Assess the Safety of RAPN for Hilar Tumors
Scientific Title	Un-blinded Multicenter Study to Assess the Safety of Robotic-assisted (da Vinci surgical system, DVSS) Laparoscopic Partial Nephrectomy for Hilar Tumors
Scientific Title:Acronym	Un-blinded Multicenter Study to Assess the Safety of RAPN for Hilar Tumors
Region	Japan

Condition
Condition	cT1,cN0,cM0 Hilar Tumors
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy of robotic-assisted (da Vinci surgical system, DVSS) laparoscopic partial nephrectomy for cT1,cN0,cM0 hilar tumors* in comparison with warm ischemic time of historical controls for primary endpoint evaluation. *Hilar tumor was defined as a mass less than 7 cm and located in the renal hilum and in contact with a major renal vessel on preoperative imaging.
Basic objectives2	Others
Basic objectives -Others	To assess the safety of RAPN for cT1,cN0,cM0 hilar tumors.
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Warm ischemia time (min)
Key secondary outcomes	Secondary Endpoints - Margin negative - Warm ischemia time (within 25 min or not) - Achieved both margin negative and warm ischemia time (within 25 min) - Change of pre- and post- operative ERPF (mL/min) in operated kidney - Change of split (%) multiplied by eGFR in operated kidney - eGFR - Overall survival time - Recurrence-free survival time Safety Endpoints - Failure of DVSS - Adverse Events Other Endpoints - Operative Time - Console Time - Blood Loss - Conversion to open surgery or laparoscopic surgery

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	Laparoscopic partial nephrectomy using da Vinci surgical system (DVSS)
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) The tumor is diagnosed as the mass located in the renal hilum in contact with a major renal vessels on preoperative imaging, either CT* abdomen scan or MRI (if the patient is unable to take the contrast agent) and an indication for partial nephrectomy. (*slice of contrast enhanced CT abdomen must be <5 mm) 2) The tumor is less than 7 cm (cT1) 3) Detecting no metastasis of lymph node or intra-abdominal organ by either contrast enhanced CT* abdomen scan or MRI (if the patient is unable to take the contrast agent). (cN0,cM0). 4) Detecting no metastasis by the contrast enhanced CT chest scan or bone scintigraphy. 5) Single tumor 6) The subject's laboratory test results wthin 12 weeks before registration are as follows -WBC > 3000/microL -Plt >= 10x10^4/microL -AST =< 100 IU/L -ALT =< 100 IU/L -Total Bilirubin =< 2.0 mg/dL -Serum creatinine =< 2.0 mg/dL 7)>= 20 years of age at the informed consent. 8)Written informed consent is obtained.
Key exclusion criteria	1)multiple cancer 2)history of kidney transplantation. 3)therapies for renal cell cancer in the past 6 months. 4) Has a high risk to general anesthesia 5) unable to withdrawal of anticoagulation 6) anemia or hemorrhagic tendency requiring transfusion 7) obesity(Body Mass Index:BMI>=35) 8) dialysis patient. 9) pregnant, suspected of being pregnant, or lactating woman. 10) difficult to participate the study due to psychiatric disorder or psychological symptom. 11 )Judged as an inappropriate patient by the investigator or sub-investigator at the hospital (site) for any other reasons.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Masato Middle name Last name ujisawa
Organization	Kobe University Graduate School of Medicine
Division name	Division of Urology, Department of Surgery Related
Zip code	650-0017
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	1st name Nobuyuki Middle name Last name Hinata
Organization	Kobe University Graduate School of Medicine
Division name	Division of Urology, Department of Surgery Related
Zip code	650-0017
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
Institute
Department

Funding Source
Organization	Intuitive Surgical, Inc./CA, USA
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	IRB, Kobe University Hospital
Address	7-5-2, Kusunokicho, Chuoku, Kobe, 650-0017, Japan
Tel	078-382-6669
Email	chiken@med.kobe-u.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	2016 Year 09 Month 20 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	No longer recruiting
Date of protocol fixation	2016 Year 09 Month 01 Day
Date of IRB	2016 Year 09 Month 01 Day
Anticipated trial start date	2016 Year 12 Month 01 Day
Last follow-up date	2023 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 09 Month 07 Day
Last modified on	2021 Year 09 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027593