UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000001075
Receipt No. R000001307
Scientific Title Intraoperative fluorescent imaging techniques using indocyanine green for cholangiography and identification of primary and secondary liver cancers
Date of disclosure of the study information 2008/03/21
Last modified on 2020/03/24 (Ver. 8)

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Basic information
Public title Intraoperative fluorescent imaging techniques using indocyanine green for cholangiography and identification of primary and secondary liver cancers
Acronym Intraoperative fluorescent imaging with ICG for cholangiography and identification of liver cancers
Scientific Title Intraoperative fluorescent imaging techniques using indocyanine green for cholangiography and identification of primary and secondary liver cancers
Scientific Title:Acronym Intraoperative fluorescent imaging with ICG for cholangiography and identification of liver cancers
Region
Japan

Condition
Condition Malignant or benign hepatobiliary diseases which require surgeries
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 1 To evaluate the ability of fluorescent imaging techniques to delineate biliary tracts during surgery
2 To evaluate the ability of fluorescent imaging techniques to detect primary and secondary liver cancers on liver surfaces during surgery or on surgical specimens
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1 Detectability of biliary tracts
2 Detectability of liver cancers
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
Maneuver
Interventions/Control_1 Fluorescent imaging techniques using intrabiliary or intravenously-injected indocyanine green for intraoperative cholangiography and/or identification of liver cancers
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 1 Patients who are to undergo hepatibiliary surgery which will require intraoperative cholangiography
2 Patients who are to undergo liver resection for primary or secondary liver cancers
Key exclusion criteria Patients with a past history of allergic reactions to iodine
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Norihiro
Middle name
Last name okudo
Organization Graduate School of Medicine, University of Tokyo
Division name Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code 113-8655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL 03-3815-5411
Email KOKUDO-2SU@h.u-tokyo.ac.jp

Public contact
Name of contact person
1st name Takeaki
Middle name
Last name Ishizawa
Organization Graduate School of Medicine, University of Tokyo
Division name Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code 113-8655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email tish-tky@umin.ac.jp

Sponsor
Institute University of Tokyo Hospital
Institute
Department

Funding Source
Organization University of Tokyo Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor SOCIAL INSURANCE CENTRAL GENERAL HOSPITAL
Name of secondary funder(s)

IRB Contact (For public release)
Organization The University of Tokyo
Address 7-3-1 Hongo Bunkyo-ku Tokyo
Tel 03-3815-5411
Email liaison@m.u-tokyo.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
2008 Year 03 Month 21 Day

Related information
URL releasing protocol None
Publication of results Published

Result
URL related to results and publications 10.1097/MD.0000000000001005, 10.1097/MD.0000000000001005
Number of participants that the trial has enrolled 278
Results 
Fluorescence cholangiography delineated the confluence between the cystic duct and common hepatic duct before and after dissection of triangle of Calot in 80 patients and 99 patients, respectively. In hepatectomy, ICG fluorescence imaging enabled identification of 273 of 276 HCCs in the resected specimens. HCCs showed that concerous-type fluorescence was associated with higher cancer cell differentiation as compared with rim-type HCCs (P less than 0.001).
Results date posted
2020 Year 03 Month 24 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Patients undergoing laparoscopic cholecystectomy (n=108) or hepatectomy (n=170)
Participant flow 
1) Following preoperative intravenous injection of ICG (2.5mg), fluorescence images of the extrahepatic bile ducts were obtained with near-infrared camera systems.
2) Following preoperative intravenous injection of ICG (0.5 mg/kg), fluorescence imaging of the hepatic surfaces and resected specimens were performed.
Adverse events 
None
Outcome measures 
Detectabilities of the extrahepatic bile ducts and hepatic tumors during surgery by ICG-fluorescence imaging.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2007 Year 06 Month 01 Day
Date of IRB
2007 Year 06 Month 01 Day
Anticipated trial start date
2007 Year 07 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 03 Month 13 Day
Last modified on
2020 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001307