Hepatic EncephalopathyNCT06367127
Utility of the Clamping Bean Test (CBT) for Covert Hepatic Encephalopathy Screening
An observational study of Hepatic Encephalopathy and Covert Hepatic Encephalopathy, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
Hepatic encephalopathy is a brain dysfunction caused by liver insufficiency and/or porto-systemic shunt. It manifests as a wide spectrum of neurological or psychiatric abnormalities ranging from subclinical alterations to coma. According to the symptoms, it is classified as covert HE (CHE) and overt HE (OHE). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Encephalopathy, Covert Hepatic Encephalopathy
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2023to 31 Dec 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Inverstigators will include about 200 healthy volunteers as the healthy control as well. And the data on participants' demographic characteristics, disease history, labratory characteristics and current treatment will be collected.
Who may be able to join
- written informed consent;
- Age 18-70 years old;
- Patients with clinical diagnosis of liver cirrhosis and without current OHE.
Who cannot join
- Presence of other uncontrollable neuro-psychiatric or neurological diseases that affect cognitive function, such as Alzheimer's disease, Parkinson's disease, schizophrenia, etc.;
- Clinically diagnosed as overt hepatic encephalopathy(OHE);
- Consumption of hypnotic or sedative drug and psychotropic drug in the past 4 weeks;
- Alcohol consumption >50 g/day within the past 3 months;
- Conditions preventing the patient from completing the test independently (for instance, red-green color blindness, difficulty in comprehension).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utility of the Clamping Bean Test (CBT) for Covert Hepatic Encephalopathy Screening in Cirrhotic Patients
Hepatic encephalopathy is a brain dysfunction caused by liver insufficiency and/or porto-systemic shunt. It manifests as a wide spectrum of neurological or psychiatric abnormalities ranging from subclinical alterations to coma. According to the symptoms, it is classified as covert HE (CHE) and overt HE (OHE). CHE can progress to OHE and is associated with reduced driving ability, increased risk of accidents and hospitalization and weakened health-related quality of life, resulting in poor prognosis and socio-economic status. However, due to the absence of readily identifiable clinical symptoms and signs, CHE is often neglected in clinical practice.
Presently, the diagnosis of CHE depends on psychometric and neurophysiological tests, including the psychometric hepatic encephalopathy score (PHES), critical flicker frequency (CFF) test, continuous reaction time (CRT) test, inhibitory control test, the SCAN test, and electroencephalography. Among them, PHES is most widely used and recommended by several guidelines. However, it is difficult to screen CHE among all cirrhotic patients in the clinic using PHES because of the time required and a dependence on trained experts.
Moving beans from one container to another with tweezers involves dexterity, agility and coordination.The hypothesis was that the utility of the Clamping Bean Test (CBT) will enable early screening patients with CHE.
- Medical subject headings
- Hepatic Encephalopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Beans Clamping in 1 minute
Moving beans from one container to another with tweezers in one minute, and then count the number of beans
Measured: 1 minute
Secondary outcomes (1)
Participants' feedback on CBT1 test
Participnants will be asked to complete the questionnaire of the feedback on CBT1 test
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start9 Oct 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lvping Sun, Study chair, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367127
- Sponsor's protocol ID
- Pingfanghu
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of the Clamping Bean Test (CBT) for Covert Hepatic Encephalopathy Screening in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT06367127
- Acronym / sponsor ID
- Pingfanghu
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Apr 2024 (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.
Hepatic encephalopathy is a brain dysfunction caused by liver insufficiency and/or porto-systemic shunt. It manifests as a wide spectrum of neurological or psychiatric abnormalities ranging from subclinical alterations to coma. According to the symptoms, it is classified as covert HE (CHE) and overt HE (OHE). CHE can progress to OHE and is associated with reduced driving ability, increased risk of accidents and hospitalization and weakened health-related quality of life, resulting in poor prognosis and socio-economic status. However, due to the absence of readily identifiable clinical symptoms and signs, CHE is often neglected in clinical practice.
Presently, the diagnosis of CHE depends on psychometric and neurophysiological tests, including the psychometric hepatic encephalopathy score (PHES), critical flicker frequency (CFF) test, continuous reaction time (CRT) test, inhibitory control test, the SCAN test, and electroencephalography. Among them, PHES is most widely used and recommended by several guidelines. However, it is difficult to screen CHE among all cirrhotic patients in the clinic using PHES because of the time required and a dependence on trained experts.
Moving beans from one container to another with tweezers involves dexterity, agility and coordination.The hypothesis was that the utility of the Clamping Bean Test (CBT) will enable early screening patients with CHE.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Inverstigators will include about 200 healthy volunteers as the healthy control as well. And the data on participants' demographic characteristics, disease history, labratory characteristics and current treatment will be collected.
Key inclusion criteria (3 listed)
- written informed consent;
- Age 18-70 years old;
- Patients with clinical diagnosis of liver cirrhosis and without current OHE.
Key exclusion criteria (5 listed)
- Presence of other uncontrollable neuro-psychiatric or neurological diseases that affect cognitive function, such as Alzheimer's disease, Parkinson's disease, schizophrenia, etc.;
- Clinically diagnosed as overt hepatic encephalopathy(OHE);
- Consumption of hypnotic or sedative drug and psychotropic drug in the past 4 weeks;
- Alcohol consumption >50 g/day within the past 3 months;
- Conditions preventing the patient from completing the test independently (for instance, red-green color blindness, difficulty in comprehension).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Beans Clamping in 1 minute
Time frame: 1 minute
Moving beans from one container to another with tweezers in one minute, and then count the number of beans
1 secondary outcome
Participants' feedback on CBT1 test
Time frame: 2 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
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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. This study is not recruiting at the moment.
Lvping Sun study chair
Shanghai Changzheng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Encephalopathy and Covert Hepatic Encephalopathy, run by Shanghai Changzheng Hospital at 1 site 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Beans Clamping in 1 minute (time frame: 1 minute). 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 16 Apr 2024.