UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033058 |
|---|---|
| Receipt number | R000034344 |
| Scientific Title | A prospective exploratory study on the usefulness of Asialoglycoprotein Receptor Imaging in patients with Acute liver damage early in onset in Osaka City University (ARIA-OCU) |
| Date of disclosure of the study information | 2018/06/25 |
| Last modified on | 2020/12/21 22:42:00 |
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Basic information
Public title
A prospective exploratory study on the usefulness of Asialoglycoprotein Receptor Imaging in patients with Acute liver damage early in onset in Osaka City University (ARIA-OCU)
Acronym
Asialoglycoprotein Receptor Imaging in patients with Acute liver damage in Osaka City University (ARIA-OCU)
Scientific Title
A prospective exploratory study on the usefulness of Asialoglycoprotein Receptor Imaging in patients with Acute liver damage early in onset in Osaka City University (ARIA-OCU)
Scientific Title:Acronym
Asialoglycoprotein Receptor Imaging in patients with Acute liver damage in Osaka City University (ARIA-OCU)
Region
| Japan |
Condition
Condition
Acute liver damage
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We perform asialoglycoprotein receptor imaging using Tc-99m-galactosyl human serum albumin (GSA) within 3 weeks from onset and 1-2 months after onset in patients with acute liver damage who don't have a history of liver damage. Then we evaluate the significance by describing how the results of scintigraphy affect the decision and change of treatment policy, and we explore prospectively relations between scintigraphic results and severity and prognosis of acute liver damage.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of patients in whom chief physician judge 2nd asialoglycoprotein receptor imaging to be meaningful.
Key secondary outcomes
1. Comparison of treatment policies before and after asialoglycoprotein receptor imaging, and a rate of treatment policy change.
2. Percentage of patients falling into acute liver failure.
3. Correlation between the duration until
falling into acute liver failure and quantitative value of asialoglycoprotein receptor imaging and its rate of change.
4. Correlation between the duration of liver damage status and quantitative value of asialoglycoprotein receptor imaging and its rate of change.
5. Percentage of patients who develop hepatic coma above II degree.
6. Correlation between the duration until developing hepatic coma above II degree and quantitative value of asialoglycoprotein receptor imaging and its rate of change.
7. Percentage of patients who died from acute liver failure.
8. Correlation between the duration until death due to acute liver failure and quantitative value of asialoglycoprotein receptor imaging and its rate of change.
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
Prevention
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
We perform asialoglycoprotein receptor imaging in patients with acute liver damage within 3 weeks and 1 to 2 months after the onset of acute liver damage. The dose of Tc-99m-GSA used for each asialoglycoprotein receptor imaging is 185 MBq. We calculate quantitative value of asialoglycoprotein receptor imaging at each time point and evaluate functional hepatic reserve. Then we investigate a significance by describing how the results of scintigraphy affect the decision and change of treatment policy.
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. Over 20 years old.
2. Asialoglycoprotein receptor imaging can be performed within 3 weeks from the onset of acute liver damage. The definition of acute liver damage is "patients showing alanine transferase values of 100 IU/L or more or total bilirubin values of 3.0 mg/dL or more due to acute liver damage, where the liver function prior to the current onset of liver damage is estimated to have been normal based on laboratory tests and imaging tests.
Key exclusion criteria
1. Severe psychiatric disorder or psychiatric symptom is merged. (provided, however, judged by the attending physician.)
2. Asialoglycoprotein receptor imaging can not be performed due to poor general condition.
3. Long-term resting supine position is difficult due to back pain.
4. Pregnant or lactating woman.
5. In a case that the researchers judge it is difficult to carry out the study.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Kotani |
Organization
Osaka City University Graduate School of Medicine
Division name
Hepatology
Zip code
545-8585
Address
1-4-3 Asahimachi, Abeno-ku, Osaka
TEL
06-6645-3905
kouhei-k@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Kotani |
Organization
Osaka City University Graduate School of Medicine
Division name
Hepatology
Zip code
45-8585
Address
1-4-3 Asahimachi, Abeno-ku, Osaka
TEL
06-6645-3905
Homepage URL
kouhei-k@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (KAKENHI)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka city university hospital echics committee
Address
1-2-7-601 Asahimachi, Abeno-ku, Osaka, Japan
Tel
06-6645-3456
ethics@med.osaka-cu.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
| 2018 | Year | 06 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 19 | Day |
Last modified on
| 2020 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034344
