UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study of navigation surgery for hepatoblastoma using Indocyanine Green (ICG)
Title of the study (Brief title)	Clinical study of navigation surgery for hepatoblastoma using Indocyanine Green (ICG)
Region	Japan

Condition
Condition	Hepatoblastoma
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine the effectiveness of ICG-guided surgery to achieve complete resection of hepatoblastomas, which are not visible by current image modalities.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pathological accuracy of the specimens that are positive for ICG
Key secondary outcomes	To prove the non-inferiority of ICG navigation surgery compared with current available image modalities, and survival proportions in 1,3,5 years after the surgery.

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	Intravenous injection of ICG 0.5mg/kg, 24-72 hours before the operation. Visualization of lesions taking up ICG by a fluorescent camera at the time of operation.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients suspected with primary or metastatic hepatoblastoma
Key exclusion criteria	Ones who are allergic to ICG or Iodine or who are ineligible for surgery are excluded.
Target sample size	10

Research contact person
Name of lead principal investigator	Tatsuo Kuroda
Organization	Keio University School of Medicine
Division name	The department of pediatric surgery
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.
TEL	+81-3-5363-3024
Email	kuroda-t@z8.keio.jp

Public contact
Name of contact person	Teizaburo Mori
Organization	Keio University School of Medicine
Division name	The department of pediatric surgery
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.
TEL	+81-3-5363-3024
Homepage URL
Email	0105mori@keio.jp

Sponsor
Institute	Keio University School of Medicine, the department of pediatric surgery
Institute
Department

Funding Source
Organization	Keio University School of Medicine
Organization
Division
Category of Funding Organization	Other
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	慶応義塾大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 10 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 03 Month 10 Day
Anticipated trial start date	2017 Year 03 Month 10 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	2017 Year 03 Month 09 Day
Last modified on	2018 Year 03 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030334