UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051252 |
|---|---|
| Receipt number | R000058447 |
| Scientific Title | The usefulness of multiparametric ultrasound for the assessment of patients with autoimmune hepatitis |
| Date of disclosure of the study information | 2023/06/03 |
| Last modified on | 2023/06/03 14:39:52 |
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Basic information
Public title
The usefulness of multiparametric ultrasound for the assessment of patients with autoimmune hepatitis
Acronym
AIH study
Scientific Title
The usefulness of multiparametric ultrasound for the assessment of patients with autoimmune hepatitis
Scientific Title:Acronym
AIH study
Region
| Japan |
Condition
Condition
Autoimmune hepatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to evaluate the relationship between three ultrasonic parameters (Liver stiffness [LS], Dispersion slope [DS], Attenuation coefficient [AC]) measured by multiparametric ultrasound and tissue parameters (degree of necroinflammatory activity, degree of fibrosis, degree of steatosis) obtained from liver biopsy, and to clarify the usefulness of multiparametric ultrasound in the assessment of disease states in Autoimmune Hepatitis (AIH).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The correlation between ultrasonic parameters (LS, DS, AC) and pathological parameters (fibrosis, lobular inflammation, steatosis).
Key secondary outcomes
1.Diagnostic capability of liver fibrosis by LS (F0 vs. F1234, F01 vs. F234, F012 vs. F34, F0123 vs. F4)
2.Diagnostic capability of lobular inflammation by DS (A0 vs. A123, A01 vs. A23, A012 vs. A3)
3.Diagnostic capability of liver steatosis by AC (S0 vs. S123, S01 vs. S23, S012 vs. S3)
4.Progression of ultrasound parameters before treatment and 3, 6, 9, 12 months after treatment initiation.
5.The impact of subcutaneous thickness on ultrasound parameters (LS, DS, AC).
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) Patients who are suspected to have Autoimmune Hepatitis (AIH) and are scheduled for liver biopsy
2) Patients from whom other diseases have been excluded (such as alcohol, drugs, viral infections, metabolic diseases, cases with PBC)
3) Men and women aged 20 and above
Key exclusion criteria
1) Patients who the principal investigator or co-investigator has deemed unsuitable for this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Katsutoshi |
| Middle name | |
| Last name | sugimoto |
Organization
Tokyo Medical University Hospital
Division name
Dept of Gastroenterology and Hepatology
Zip code
160-0023
Address
6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
sugimoto@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Katsutoshi |
| Middle name | |
| Last name | Sugimoto |
Organization
Tokyo Medical University Hospital
Division name
Dept of Gastroenterology and Hepatology
Zip code
160-0023
Address
6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
Homepage URL
sugimoto@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University Institutional Review Board
Address
6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo
Tel
03-3342-6111
IRB@tokyo-med.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
東京医科大学病院（東京都）、岩手医科大学病院（岩手県）、福島県立医科大学病院（福島県）、大垣市民病院（岐阜県）、愛媛大学大学院（愛媛県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Perform multiparametric ultrasound on the target patients and measure three image parameters (LS, DS, AC). The ultrasound diagnostic device used for this purpose is the Aplio i800 (manufactured by Canon Medical Systems), capable of imaging multiparametric ultrasound, using the abdominal convex probe PVI-475BX.
2. For patients who underwent liver biopsy for the purpose of evaluating AIH, multiparametric ultrasound should be performed within one month before and after the liver biopsy. It is desirable to scan the same area as the biopsy as much as possible during the measurement of multiparametric ultrasound. For patients with untreated AIH, multiparametric ultrasound imaging should be performed before initiating AIH treatment. In addition to the initial treatment, multiparametric ultrasound should be performed at 3, 6, 9, and 12 months, along with peripheral blood and biochemical tests, serum IgG, and measurement of liver fibrosis markers (Fibrosis-4 index, M2BPGi).
3. The collected multiparametric ultrasound image data should be sent to the research office after removing personal data at each facility.
4. Patient backgrounds, blood test findings, and treatment details should be assigned an identification ID after removing personal data at each facility and sent to the research office.
5. The liver biopsy tissue specimens collected at each facility should be sent to the Department of Pathology, Kanazawa University, after removing personal data at each facility. The evaluation of AIH activity and fibrosis will be conducted using the new Inuyama classification and modified HAI score, and the evaluation of steatosis will be assessed using the NAFLD Activity Score. The pathological reports generated by Kanazawa University will be sent to the research office.
6. Statistical analysis of the collected data will be conducted at Tokyo Medical University Hospital.
Management information
Registered date
| 2023 | Year | 06 | Month | 03 | Day |
Last modified on
| 2023 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058447
