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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000033921
Receipt No. 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

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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
Email 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
Email hara@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038685

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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