UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study for feasibility of monitoring renal blood flow in robot assisted partial nephrectomy
Title of the study (Brief title)	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	Isao Hara
Organization	Wakayama Medical University
Division name	Department of Urology
Address	811-1 Kimiidera, Wakayama City
TEL	073-441-0637
Email	hara@wakayama-med.ac.jp

Public contact
Name of contact person	Isao Hara
Organization	Wakayama Medical University
Division name	Department of Urology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 12 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000038685