UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001075 |
|---|---|
| Receipt number | 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 12:57:43 |
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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
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
tish-tky@umin.ac.jp
Sponsor or person
Institute
University of Tokyo Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001307
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| Registered date | File name |
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