UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023968 |
|---|---|
| Receipt number | 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 | 2021/09/14 09:44:14 |
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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 | 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
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
uro6155@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027593
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| Registered date | File name |
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| Registered date | File name |
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