UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051209 |
|---|---|
| Receipt number | R000058408 |
| Scientific Title | Exploratory clinical research to establish a novel method for measuring liver function using a fluorescence spectrometer |
| Date of disclosure of the study information | 2023/05/31 |
| Last modified on | 2024/07/07 13:20:31 |
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Basic information
Public title
Exploratory clinical research to establish a novel method for measuring liver function using a fluorescence spectrometer
Acronym
Fluorence spectrometer liver function
Scientific Title
Exploratory clinical research to establish a novel method for measuring liver function using a fluorescence spectrometer
Scientific Title:Acronym
Fluorence spectrometer liver function
Region
| Japan |
Condition
Condition
Cholecystlithialsis Gastric tumor Pancreatic tumor Biliary tumor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Correlate the fluorescence intensity of the liver surface obtained by Lumifinder with ICG regression rate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The correlation coefficient between fluorescence intensity on the liver surface obtained by Lumifinder and ICG regression rate.
Key secondary outcomes
(1) Correlation between fluorescence intensity change rate in left and right lobes of liver
(2) Correlation between ICGK in blood and the rate of change of fluorescence intensity
(3) Correlation between measurement results of other modalities and rate of change of fluorescence intensity on the liver surface
(iv) Correlation between the rate of change of fluorescence intensity and the results of blood biochemical tests (AT-III, total bilirubin level, liver enzymes, and biliary enzymes) after hepatectomy.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Persons who are 20 years of age or older at the time of obtaining consent.
(2) Persons who have received a full explanation of their participation in this research and who have given the consent of their own free will based on a thorough understanding of the subject's situation.
Key exclusion criteria
Patients with any one of the following conditions shall be excluded
(i) Patients with a history of hepatectomy or common bile duct resection
(2) Patients with a history of allergy to Dianogreen
(iii) Patients with known dianogreen excretion disorder
(iv) Patients with a history of iodine allergy
(5) Patients with a history of upper abdominal surgery
(vi) Patients who have received anti-tumour therapy (chemotherapy or radiation therapy) within six months prior to the surgery
(vii) Other subjects deemed inappropriate as research subjects by the principal investigator or sub-investigator.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Takehiro |
| Middle name | |
| Last name | Noji |
Organization
Hokkaido University Faculty of medicine
Division name
Faculty of Medicine Gastroenterological surgery II
Zip code
060-8638
Address
Kita15 Nishi 7, Kita-ku, Sapporo city
TEL
0117067714
drnoji@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Takehiro |
| Middle name | |
| Last name | Noji |
Organization
Hokkaido University Faculty of Medicine
Division name
Gastroenterological surgery II
Zip code
060-8638
Address
Kita15 Nishi7, Kita-ku, Sapporo city,
TEL
0117067714
Homepage URL
drnoji@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Takehiro Noji
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University IRB
Address
Kita14 Nishi5, Kita-ku, Sapporo city
Tel
0117161161
crjimu@huhp.hokudai.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
北海道大学病院 （北海道）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A Lumifinder is inserted intraoperatively into the body cavity and the fluorescence emitted by the liver is measured. Indocyanine Green (ICG) is administered and the fluorescence emitted by ICG is measured for 3/5/10/15 minutes and the rate of ICG disappearance is measured by taking blood samples.
Management information
Registered date
| 2023 | Year | 05 | Month | 31 | Day |
Last modified on
| 2024 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058408
