Electronic PHES vs Paper-based PHES for Hepatic Encephalopathy

NCT07852416 | Not Yet Recruiting

• 1 other identifier: 2026-SR-580
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective, multicenter, randomized crossover diagnostic accuracy study. A total of 80 patients with liver cirrhosis will be enrolled and randomly assigned to two sequence groups at a 1:1 ratio. Participants in Sequence A will complete the paper-based Psychometric Hepatic Encephalopathy Score (PHES) on Day 1 and the electronic PHES on Day 2; participants in Sequence B will receive the tests in reverse order. All tests will be performed at the same time of day with a 1-day washout interval to minimize carryover effect. The primary objective is to verify the equivalence of total scores between electronic and paper-based PHES. Secondary objectives include evaluating the consistency of MHE classification and individual subtest scores, and analyzing the effects of test sequence and time period on results. This study aims to provide evidence for clinical promotion of the electronic PHES tool.

Conditions

Liver Cirrhosis; Hepatic Encephalopathy; Minimal Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (1)

• Mean difference in total PHES score (electronic version minus paper version)

  Paired difference of total PHES score between electronic and paper-based versions within the same participant. Equivalence will be verified by the two one-sided t-test (TOST), with the equivalence margin defined as -1 to +1 points. Equivalence is concluded if the 90% confidence interval of the mean difference falls entirely within the margin.

  Day 1, Day 2

Study Arms (2)

Group A (Paper-then-Electronic Sequence)

OTHER

Participants receive paper-based PHES test on Day 1, and receive electronic PHES test on Day 2 with a 1-day washout interval between two tests.

Diagnostic Test: Paper-based Psychometric Hepatic Encephalopathy Score (PHES); Diagnostic Test: Electronic Psychometric Hepatic Encephalopathy Score (PHES)

Group B (Electronic-then-Paper Sequence)

OTHER

Participants receive electronic PHES test on Day 1, and receive paper-based PHES test on Day 2 with a 1-day washout interval between two tests.

Diagnostic Test: Paper-based Psychometric Hepatic Encephalopathy Score (PHES); Diagnostic Test: Electronic Psychometric Hepatic Encephalopathy Score (PHES)

Interventions

Paper-based Psychometric Hepatic Encephalopathy Score (PHES) DIAGNOSTIC_TEST

Standard paper-and-pencil version of PHES, including 5 subtests (NCT-A, NCT-B, DST, LTT, SDT), administered by trained investigators according to standard protocol.

Group A (Paper-then-Electronic Sequence); Group B (Electronic-then-Paper Sequence)

Electronic Psychometric Hepatic Encephalopathy Score (PHES) DIAGNOSTIC_TEST

Electronic mini-program version of PHES with identical subtests and scoring criteria as the paper version, administered on a tablet or smartphone.

Group A (Paper-then-Electronic Sequence); Group B (Electronic-then-Paper Sequence)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 75 years
• Confirmed diagnosis of liver cirrhosis based on clinical, laboratory, imaging, or liver biopsy evidence
• Intact cognitive function, no overt hepatic encephalopathy (West-Haven grade ≥ II), and able to cooperate with neuropsychological tests
• Voluntarily signed written informed consent with good compliance and full understanding of the study

You may not qualify if:

• Concomitant uncontrolled neuropsychiatric diseases affecting cognitive function (e.g., Alzheimer's disease, Parkinson's disease, post-stroke sequelae, severe depression/anxiety, schizophrenia)
• Use of hypnotics, sedatives, or psychotropic drugs within the past 1 month
• Severe alcohol dependence or substance abuse, unable to maintain abstinence
• Current use of lactulose at screening

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (2)

The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province People's Hospital)

Nanjing, Jiangsu, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Location

MeSH Terms

Conditions

Liver Cirrhosis; Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Longfeng Jiang

CONTACT

+86 13701583756; longfengjiang@jnmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: October 1, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-08

Locations

CN (2)