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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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


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

Value
https://center6.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