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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name