Liver CirrhosisNCT07874204
Equivalence of Electronic vs Paper-based PHES in Diagnosing Hepatic Encephalopathy
A study testing Paper-based PHES and Electronic PHES in people with Liver Cirrhosis and Hepatic Encephalopathy (HE), run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Trial summary
The goal of this clinical trial is to learn if an electronic version of the Psychometric Hepatic Encephalopathy Score (PHES) works as well as the standard paper version to diagnose minimal hepatic encephalopathy (MHE) in adults with liver cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis, Hepatic Encephalopathy (HE), Minimal Hepatic Encephalopathy
- What is being tested?
- Paper-based PHES and Electronic 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
- No sites listed yet
- Study dates
- Oct 2026to Dec 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years. Diagnosed with liver cirrhosis (based on clinical, laboratory, imaging, or liver biopsy).
- Good cognition, no overt hepatic encephalopathy (OHE, West-Haven grade ≥ II), and able to cooperate with neuropsychological tests.
- Voluntary signing of informed consent, good compliance, and fully understanding this clinical study.
Who cannot join
- Uncontrolled neuropsychiatric disorders affecting cognitive function (e.g., Alzheimer's disease, Parkinson's disease, stroke sequelae, severe depression/anxiety, schizophrenia, etc.).
- Use of hypnotics, sedatives, or psychotropic drugs within the past month. Severe alcohol dependence or drug abuse history, unable to cooperate with alcohol withdrawal or drug cessation.
- Use of lactulose at screening.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy Evaluation of Electronic Psychometric Hepatic Encephalopathy Score (PHES) in Diagnosing Hepatic Encephalopathy Based on a Randomized Crossover Design
The goal of this clinical trial is to learn if an electronic version of the Psychometric Hepatic Encephalopathy Score (PHES) works as well as the standard paper version to diagnose minimal hepatic encephalopathy (MHE) in adults with liver cirrhosis. The main questions it aims to answer are:
Do the total scores of the electronic and paper tests match for the same patient? Do both tests classify patients as having MHE or not in the same way? Researchers will compare the electronic PHES to the paper PHES to see if they produce equivalent results.
Read more
Participants will:
Be assigned by chance to one of two groups. Group A will take the paper test first, then the electronic test the next day. Group B will take the electronic test first, then the paper test the next day.
Complete two cognitive tests (one paper-based and one electronic) on two separate days.
Provide information about their medical history and complete routine blood tests as part of their standard care.
Read the detailed description
Background: Hepatic encephalopathy (HE) is a common complication of liver cirrhosis. Minimal hepatic encephalopathy (MHE) often goes undiagnosed but is associated with an increased risk of overt HE and poorer survival. The Psychometric Hepatic Encephalopathy Score (PHES) is the recommended tool for MHE screening. However, the paper-based PHES is time-consuming, requires trained personnel, and is prone to data recording errors, limiting its widespread use. We developed an electronic PHES application with identical test contents to address these limitations.
Objective: This study aims to evaluate the equivalence of the electronic PHES compared to the paper-based PHES in patients with liver cirrhosis. The secondary objectives include comparing the consistency of MHE classification, subtest scores, and analyzing the effects of test time and sequence.
Methods: This is a prospective, multicenter, randomized crossover trial. A total of 80 patients with cirrhosis will be enrolled. Patients will be randomly assigned 1:1 to Group A (paper-based PHES on Day 1, electronic PHES on Day 2) or Group B (electronic PHES on Day 1, paper-based PHES on Day 2), with tests conducted at the same time of day.
Outcomes: The primary outcome is the intra-individual difference in total PHES scores (electronic minus paper-based). The equivalence margin is set at -1 to +1 points, evaluated using the two one-sided t-test (TOST) with a 90% confidence interval. Secondary outcomes include the Kappa coefficient for MHE classification consistency, the intraclass correlation coefficient (ICC) for subtest consistency, and a linear mixed-effects model to analyze sequence and period effects.
Analysis: Statistical analysis will be performed using SPSS 26.0 and GraphPad Prism 9. Continuous variables will be presented as mean ± standard deviation or median (interquartile range). Categorical variables will be presented as frequencies (percentages). P < 0.05 will be considered statistically significant.
- Being tested
- Paper-based PHES, Electronic PHES
- Keywords
- Psychometric Hepatic Encephalopathy Score, PHES, Minimal Hepatic Encephalopathy
- 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 PHESDiagnostic test
The paper-based PHES is a standard, validated neuropsychological test administered using paper forms and a pen. It consists of five subtests: Number Connection Test A, Number Connection Test B, Digit Symbol Test, Line-Tracing Test, and Serial Dotting Test. Participants complete the test under the supervision of a trained researcher. The researcher records the completion time and error rates for each subtest, and the total PHES score is calculated manually according to standard guidelines.
Electronic PHESDiagnostic test
The electronic PHES is a digital version of the standard PHES administered via a mobile application on a tablet or smartphone. The test content, subtest settings, and scoring criteria are identical to the paper-based version. The application automatically records completion times, errors, and calculates the total score. Researchers provide operational instructions and supervise the participants throughout the test.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Paper-based PHES then Electronic PHES | Experimental | Participants in Group A will take the paper-based PHES on Day 1, followed by the electronic PHES on Day 2. Receives: Diagnostic Test: Paper-based PHES; Diagnostic Test: Electronic PHES |
| Group B: Electronic PHES then Paper-based PHES | Experimental | Participants in Group B will take the electronic PHES on Day 1, followed by the paper-based PHES on Day 2. Receives: Diagnostic Test: Paper-based PHES; Diagnostic Test: Electronic PHES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-individual Difference in Total PHES Scores (Electronic minus Paper-based)
The primary outcome is the intra-individual difference in total PHES scores between the electronic and paper-based tests. The equivalence margin is set at -1 to +1 points, evaluated using the Two One-Sided Tests (TOST) with a 90% confidence interval.
Measured: Upon completion of testing on Day 1 and Day 2
Secondary outcomes (3)
Consistency of MHE Classification
Agreement in the classification of Minimal Hepatic Encephalopathy (MHE) between the electronic and paper-based PHES, analyzed using Kappa statistics.
Measured: Upon completion of testing on Day 1 and Day 2
Consistency of Subtest Scores
Agreement of scores across the five subtests (NCT-A, NCT-B, DST, LTT, SDT) between the electronic and paper-based PHES, analyzed using Intraclass Correlation Coefficient (ICC).
Measured: Upon completion of testing on Day 1 and Day 2
Effect of Test Sequence and Time Period
Analysis of the effects of test sequence and period on PHES scores using linear mixed-effects models.
Measured: Upon completion of testing on Day 1 and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- Model description
- Participants are randomly assigned 1:1 to two sequence groups. Group A receives the paper-based PHES on Day 1 followed by the electronic PHES on Day 2. Group B receives the electronic PHES on Day 1 followed by the paper-based PHES on Day 2. Tests are conducted at the same time of day, with a 1-day washout period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Zhang, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874204
- Sponsor's protocol ID
- PHES-2026-0807-01
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
European Association for the Study of the Liver. EASL Clinical Practice Guidelines on the management of hepatic encephalopathy. J Hepatol. 2022 Sep;77(3):807-824. doi: 10.1016/j.jhep.2022.06.001. Epub 2022 Jun 17.
PubMed 35724930
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of Electronic Psychometric Hepatic Encephalopathy Score (PHES) in Diagnosing Hepatic Encephalopathy Based on a Randomized Crossover Design
- ClinicalTrials.gov ID
- NCT07874204
- Acronym / sponsor ID
- PHES-2026-0807-01
- Keywords
- Psychometric Hepatic Encephalopathy Score, PHES, Minimal Hepatic Encephalopathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 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.
The goal of this clinical trial is to learn if an electronic version of the Psychometric Hepatic Encephalopathy Score (PHES) works as well as the standard paper version to diagnose minimal hepatic encephalopathy (MHE) in adults with liver cirrhosis. The main questions it aims to answer are:
Do the total scores of the electronic and paper tests match for the same patient? Do both tests classify patients as having MHE or not in the same way? Researchers will compare the electronic PHES to the paper PHES to see if they produce equivalent results.
Participants will:
Be assigned by chance to one of two groups. Group A will take the paper test first, then the electronic test the next day. Group B will take the electronic test first, then the paper test the next day.
Complete two cognitive tests (one paper-based and one electronic) on two separate days.
Provide information about their medical history and complete routine blood tests as part of their standard care.
Detailed description
Background: Hepatic encephalopathy (HE) is a common complication of liver cirrhosis. Minimal hepatic encephalopathy (MHE) often goes undiagnosed but is associated with an increased risk of overt HE and poorer survival. The Psychometric Hepatic Encephalopathy Score (PHES) is the recommended tool for MHE screening. However, the paper-based PHES is time-consuming, requires trained personnel, and is prone to data recording errors, limiting its widespread use. We developed an electronic PHES application with identical test contents to address these limitations.
Objective: This study aims to evaluate the equivalence of the electronic PHES compared to the paper-based PHES in patients with liver cirrhosis. The secondary objectives include comparing the consistency of MHE classification, subtest scores, and analyzing the effects of test time and sequence.
Methods: This is a prospective, multicenter, randomized crossover trial. A total of 80 patients with cirrhosis will be enrolled. Patients will be randomly assigned 1:1 to Group A (paper-based PHES on Day 1, electronic PHES on Day 2) or Group B (electronic PHES on Day 1, paper-based PHES on Day 2), with tests conducted at the same time of day.
Outcomes: The primary outcome is the intra-individual difference in total PHES scores (electronic minus paper-based). The equivalence margin is set at -1 to +1 points, evaluated using the two one-sided t-test (TOST) with a 90% confidence interval. Secondary outcomes include the Kappa coefficient for MHE classification consistency, the intraclass correlation coefficient (ICC) for subtest consistency, and a linear mixed-effects model to analyze sequence and period effects.
Analysis: Statistical analysis will be performed using SPSS 26.0 and GraphPad Prism 9. Continuous variables will be presented as mean ± standard deviation or median (interquartile range). Categorical variables will be presented as frequencies (percentages). P < 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned 1:1 to two sequence groups. Group A receives the paper-based PHES on Day 1 followed by the electronic PHES on Day 2. Group B receives the electronic PHES on Day 1 followed by the paper-based PHES on Day 2. Tests are conducted at the same time of day, with a 1-day washout period.
| Arm | Type | Receives |
|---|---|---|
| Group A: Paper-based PHES then Electronic PHES | Experimental | Diagnostic Test: Paper-based PHES, Diagnostic Test: Electronic PHESParticipants in Group A will take the paper-based PHES on Day 1, followed by the electronic PHES on Day 2. |
| Group B: Electronic PHES then Paper-based PHES | Experimental | Diagnostic Test: Paper-based PHES, Diagnostic Test: Electronic PHESParticipants in Group B will take the electronic PHES on Day 1, followed by the paper-based PHES on Day 2. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 75 years. Diagnosed with liver cirrhosis (based on clinical, laboratory, imaging, or liver biopsy).
- Good cognition, no overt hepatic encephalopathy (OHE, West-Haven grade ≥ II), and able to cooperate with neuropsychological tests.
- Voluntary signing of informed consent, good compliance, and fully understanding this clinical study.
Key exclusion criteria (3 listed)
- Uncontrolled neuropsychiatric disorders affecting cognitive function (e.g., Alzheimer's disease, Parkinson's disease, stroke sequelae, severe depression/anxiety, schizophrenia, etc.).
- Use of hypnotics, sedatives, or psychotropic drugs within the past month. Severe alcohol dependence or drug abuse history, unable to cooperate with alcohol withdrawal or drug cessation.
- 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 PHESThe paper-based PHES is a standard, validated neuropsychological test administered using paper forms and a pen. It consists of five subtests: Number Connection Test A, Number Connection Test B, Digit Symbol Test, Line-Tracing Test, and Serial Dotting Test. Participants complete the test under the supervision of a trained researcher. The researcher records the completion time and error rates for each subtest, and the total PHES score is calculated manually according to standard guidelines. | Diagnostic test | Group A: Paper-based PHES then Electronic PHES, Group B: Electronic PHES then Paper-based PHES |
| Electronic PHESThe electronic PHES is a digital version of the standard PHES administered via a mobile application on a tablet or smartphone. The test content, subtest settings, and scoring criteria are identical to the paper-based version. The application automatically records completion times, errors, and calculates the total score. Researchers provide operational instructions and supervise the participants throughout the test. | Diagnostic test | Group A: Paper-based PHES then Electronic PHES, Group B: Electronic PHES then Paper-based PHES |
Primary outcome
Intra-individual Difference in Total PHES Scores (Electronic minus Paper-based)
Time frame: Upon completion of testing on Day 1 and Day 2
The primary outcome is the intra-individual difference in total PHES scores between the electronic and paper-based tests. The equivalence margin is set at -1 to +1 points, evaluated using the Two One-Sided Tests (TOST) with a 90% confidence interval.
3 secondary outcomes
Consistency of MHE Classification
Time frame: Upon completion of testing on Day 1 and Day 2
Consistency of Subtest Scores
Time frame: Upon completion of testing on Day 1 and Day 2
Effect of Test Sequence and Time Period
Time frame: Upon completion of testing on Day 1 and Day 2
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 14 Oct 2026.
- Background: PubMed 35724930European Association for the Study of the Liver. EASL Clinical Practice Guidelines on the management of hepatic encephalopathy. J Hepatol. 2022 Sep;77(3):807-824. doi: 10.1016/j.jhep.2022.06.001. Epub 2022 Jun 17.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Paper-based PHES and Electronic PHES in people with Liver Cirrhosis and Hepatic Encephalopathy (HE), run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
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 3 inclusion and 3 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 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Feng Zhang (13961872835, fzdndx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-individual Difference in Total PHES Scores (Electronic minus Paper-based) (time frame: Upon completion of testing on Day 1 and Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07874204, which also lists 1 linked publication.
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 14 Oct 2026.