Liver CirrhosisNCT07852416
Electronic PHES vs Paper-based PHES for Hepatic Encephalopathy
A study testing Paper-based Psychometric Hepatic Encephalopathy Score (PHES) and Electronic Psychometric Hepatic Encephalopathy Score (PHES) in people with Liver Cirrhosis and Hepatic Encephalopathy, run by The First Affiliated Hospital with Nanjing Medical University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Cirrhosis, Hepatic Encephalopathy, Minimal Hepatic Encephalopathy
- What is being tested?
- Paper-based Psychometric Hepatic Encephalopathy Score (PHES) and Electronic Psychometric Hepatic Encephalopathy Score (PHES)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesChina
- Study dates
- 1 Oct 2026to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province People's Hospital)
Nanjing, Jiangsu
Longfeng Jiang, +86 13701583756, longfengjiang@jnmu.edu.cn
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi
Longfeng Jiang, +86 13701583756, longfengjiang@jnmu.edu.cn
About this study
Official title: Evaluation of Diagnostic Performance of Electronic Psychometric Hepatic Encephalopathy Score (PHES): A Randomized Crossover Study
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.
Read the detailed description
This is a randomized crossover diagnostic accuracy study. Each eligible participant will receive both the electronic PHES and paper-based PHES tests in a randomly assigned sequence, with a 1-day washout interval between the two tests.
- Being tested
- Paper-based Psychometric Hepatic Encephalopathy Score (PHES), Electronic Psychometric Hepatic Encephalopathy Score (PHES)
- Medical subject headings
- Liver Cirrhosis, Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Paper-based Psychometric Hepatic Encephalopathy Score (PHES); Diagnostic Test: Electronic Psychometric Hepatic Encephalopathy Score (PHES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1, Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852416
- Sponsor's protocol ID
- 2026-SR-580
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diagnostic Performance of Electronic Psychometric Hepatic Encephalopathy Score (PHES): A Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT07852416
- Acronym / sponsor ID
- 2026-SR-580
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized crossover diagnostic accuracy study. Each eligible participant will receive both the electronic PHES and paper-based PHES tests in a randomly assigned sequence, with a 1-day washout interval between the two tests.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Paper-then-Electronic Sequence) | Other | Diagnostic Test: Paper-based Psychometric Hepatic Encephalopathy Score (PHES), Diagnostic Test: Electronic Psychometric Hepatic Encephalopathy Score (PHES)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. |
| Group B (Electronic-then-Paper Sequence) | Other | Diagnostic Test: Paper-based Psychometric Hepatic Encephalopathy Score (PHES), Diagnostic Test: Electronic Psychometric Hepatic Encephalopathy Score (PHES)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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paper-based Psychometric Hepatic Encephalopathy Score (PHES)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. | Diagnostic test | Group A (Paper-then-Electronic Sequence), Group B (Electronic-then-Paper Sequence) |
| Electronic Psychometric Hepatic Encephalopathy Score (PHES)Electronic mini-program version of PHES with identical subtests and scoring criteria as the paper version, administered on a tablet or smartphone. | Diagnostic test | Group A (Paper-then-Electronic Sequence), Group B (Electronic-then-Paper Sequence) |
Primary outcome
Mean difference in total PHES score (electronic version minus paper version)
Time frame: Day 1, Day 2
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paper-based Psychometric Hepatic Encephalopathy Score (PHES) and Electronic Psychometric Hepatic Encephalopathy Score (PHES) in people with Liver Cirrhosis and Hepatic Encephalopathy, run by The First Affiliated Hospital with Nanjing Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Longfeng Jiang (+86 13701583756, longfengjiang@jnmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference in total PHES score (electronic version minus paper version) (time frame: Day 1, Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.