UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study on sentinel pelvic lymphnode analysis with Indocyanine Green (ICG) navigation for prostate cancer and bladder cancer using da Vinci Xi system
Acronym	Xi-ICG pelvic sentinel node study
Scientific Title	Clinical study on sentinel pelvic lymphnode analysis with Indocyanine Green (ICG) navigation for prostate cancer and bladder cancer using da Vinci Xi system
Scientific Title:Acronym	Xi-ICG pelvic sentinel node study
Region	Japan

Condition
Condition	prostate cancer, bladder cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We will sutdy the possibility of the appropriate lymph node dissection for prostate cancer and bladder cancer by using indocyanine green.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Lynmph flow pattern ratio, the accuracy rate of sentinel lymph nodes
Key secondary outcomes	Comparison between conventional lymph node templates and sentinel lymph nodes, safty of indocyanine green administration

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	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	After injecting ICG into the prostate gland, observe with a near infrared camera on the da Vinci Xi system and classify lymph flow. The ICG positive site within the template dissection area is dissected and additionally dissected out of the ICG positive site outside the template dissection supernatant is performed.
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	35 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1) For the cases of the robotic radical prostatectomy or cystectomy using da Vinci Xi system with clinical stage T1-T3N0-M0 2) 35 years old and over, under 85 3) ECOG performance status score: 0 and 1 4) Preserving the major organ functions for geneneral anesthesia by general condition workup within the prior 3months 5) With written consent forms by the patients themselves
Key exclusion criteria	1)Excluded those with allergic history of ICG 2)The cases with inappropriate for this study made by the persons in charge
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Masaki Middle name Last name Shimbo
Organization	St.Luke's International Hospital
Division name	Department of Urology
Zip code	1048560
Address	9-1, Akashi-cho, Chuo-ku, Tokyo, Japan
TEL	03-3541-5151
Email	mashimbo@luke.ac.jp

Public contact
Name of contact person	1st name Masaki Middle name Last name Shimbo
Organization	St.Luke's International Hospital
Division name	Department of Urology
Zip code	1048560
Address	9-1, Akashi-cho, Chuo-ku, Tokyo, Japan
TEL	03-3541-5151
Homepage URL
Email	mashimbo@luke.ac.jp

Sponsor
Institute	Department of Urology, St. Luke's International Hospital
Institute
Department

Funding Source
Organization	Department of Urology, St. Luke's International Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	St.Luke's International hospital
Address	9-1, Akashi-cho, Chuo-ku, Tokyo
Tel	0335415151
Email	kenkyukikaku@luke.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	2017 Year 05 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	Completed
Date of protocol fixation	2017 Year 03 Month 01 Day
Date of IRB	2017 Year 06 Month 08 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 03 Month 03 Day
Last modified on	2020 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030318