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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023968
Receipt No. R000027593
Scientific Title Un-blinded Multicenter Study to Assess the Safety of Robotic-assisted (da Vinci surgical system, DVSS) Laparoscopic Partial Nephrectomy for Hilar Tumors
Date of disclosure of the study information 2016/09/20
Last modified on 2017/09/10

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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
Middle name
Last name Masato Fujisawa
Organization Kobe University Graduate School of Medicine
Division name Division of Urology, Department of Surgery Related
Zip code
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
Middle name
Last name Nobuyuki Hinata
Organization Kobe University Graduate School of Medicine
Division name Division of Urology, Department of Surgery Related
Zip code
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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2016 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
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
2017 Year 09 Month 10 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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