UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046313 |
|---|---|
| Receipt number | R000052852 |
| Scientific Title | A multicenter prospective study to evaluate the utility of animal naming test for the diagnosis of covert hepatic encephalopathy |
| Date of disclosure of the study information | 2021/12/08 |
| Last modified on | 2021/12/08 01:16:01 |
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Basic information
Public title
A multicenter prospective study to evaluate the utility of animal naming test for the diagnosis of covert hepatic encephalopathy
Acronym
A multicenter prospective study to evaluate the utility of animal naming test for the diagnosis of covert hepatic encephalopathy
Scientific Title
A multicenter prospective study to evaluate the utility of animal naming test for the diagnosis of covert hepatic encephalopathy
Scientific Title:Acronym
A multicenter prospective study to evaluate the utility of animal naming test for the diagnosis of covert hepatic encephalopathy
Region
| Japan |
Condition
Condition
Liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The utility of animal naming test for the diagnosis of covert hepatic encephalopathy in patients with cirrhosis
Basic objectives2
Others
Basic objectives -Others
The relationship between animal naming test and each variable
The relationship between animal naming test and outcomes
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between animal naming test and covert hepatic encephalopathy
Key secondary outcomes
The relationship between animal naming test and each variable (sarcopenia, frailty, falls, fracture, traffic accident, quality of life).
The relationship between animal naming test and clinical outcomes (overt hepatic encephalopathy and mortality).
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 with cirrhosis or healthy volunteers aged 20 years or more
2. Written informed consent
Key exclusion criteria
1.Patients with previous shunt operation or transjunglar intrahepatic portosystemic shunt
2.Patients with infection
3.Patients with overt hepatic encephalopathy, gastrointestinal bleeding, and spontaneous bacterial peritonitis within 4 weeks
4.Patient with alcohol abuse (60 g/day or more) within 4 weeks
5.Patients with neuromuscular disease which affect the results of the neuropsychological test
6.Patients who receive medications for dementia
7.Patients with severe comorbidities such as heart, renal, and respiratory failure
8.Patients who are inadequate for the study
9.Volunteers who are initially related to the study
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Tatsunori |
| Middle name | |
| Last name | Hanai |
Organization
Gifu University Hospital
Division name
Center for Nutrition Support & Infection Control
Zip code
501-1194
Address
1-1 Yanagido, Gifu, Japan
TEL
058-230-6308
hanai@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Miwa |
Organization
Gifu University Hospital
Division name
The First Department of Internal Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu, Japan
TEL
058-230-6308
Homepage URL
miwa_t@gifu-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology/Internal medicine, Gifu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nishimino Kosei Hospital
Miwa Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of the Gifu University Graduate School of Medicine
Address
1-1 Yanagido, Gifu, Japan
Tel
058-230-6059
rinri@gifu-u.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
岐阜大学医学部附属病院（岐阜県）、西美濃厚生病院（岐阜県）、MIWA内科・胃腸科CLINIC（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 08 | 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
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aimed to evaluate the utility of animal naming test for the diagnosis of covert hepatic encephalopathy.
Management information
Registered date
| 2021 | Year | 12 | Month | 08 | Day |
Last modified on
| 2021 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052852
