UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033921 |
|---|---|
| Receipt number | R000038685 |
| Scientific Title | Prospective study for feasibility of monitoring renal blood flow in robot assisted partial nephrectomy |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2019/02/25 14:28:08 |
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Basic information
Public title
Prospective study for feasibility of monitoring renal blood flow in robot assisted partial nephrectomy
Acronym
Monitoring renal blood flow in robot assisted partial nephrectomy
Scientific Title
Prospective study for feasibility of monitoring renal blood flow in robot assisted partial nephrectomy
Scientific Title:Acronym
Monitoring renal blood flow in robot assisted partial nephrectomy
Region
| Japan |
Condition
Condition
Renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Robot assisted partial nephrectomy was covered by national health insurance in April 2016 in Japan, and is expected to be popularized in the future. Since kidney is a parenchymatous organ, it is necessary to establish avascular state by clamping renal artery, then perform tumor resection, followed by repair of the urinary tract and renal parenchyma for hemostasis. It is desirable to confirm whether the resected area is completely in an ischemic state when clamped, especially in cases where there are multiple renal arteries. Indocyanine green (ICG) is a reagent used for liver function test and cerebral vessel imaging. Intravenous administration of ICG during robot assisted partial nephrectomy allows it to bind with albumin in the blood and irradiate it with laser light, whereby blood flow can be monitored. By using this method, it is possible to know the ischemic state of the entire kidney or the resected area.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood loss during surgery
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Indocyanine green (ICG)
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
Patient with renal cell carcinoma in diameter less than 4cm who can undergo robot assisted partial nephrectomy
Key exclusion criteria
Patient who had allergic symptoms for Indocyanine green.
Patient with iodine hypersensitivity
Patient with allergic factor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Isao Hara |
Organization
Wakayama Medical University
Division name
Department of Urology
Zip code
Address
811-1 Kimiidera, Wakayama City
TEL
073-441-0637
hara@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Isao Hara |
Organization
Wakayama Medical University
Division name
Department of Urology
Zip code
Address
811-1 Kimiidera, Wakayama City
TEL
073-441-0637
Homepage URL
hara@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 09 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | 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
| 2018 | Year | 08 | Month | 27 | Day |
Last modified on
| 2019 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038685
