UMIN-CTR Clinical Trial

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
Email	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
Email	miwa_t@gifu-u.ac.jp

Sponsor
Institute	Department of Gastroenterology/Internal medicine, Gifu University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052852