Clinical trial NCT06367127: Utility of the Clamping Bean Test (CBT) for Covert Hepatic Encephalopathy Screening
Official title: Utility of the Clamping Bean Test (CBT) for Covert Hepatic Encephalopathy Screening in Cirrhotic Patients
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hepatic Encephalopathy
Covert Hepatic Encephalopathy
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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). 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.


Eligibility criteria: Inclusion Criteria:

* written informed consent;
* Age 18-70 years old;
* Patients with clinical diagnosis of liver cirrhosis and without current OHE.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Number of Beans Clamping in 1 minute
timeFrame: 1 minute
Secondary outcomes:
measure: Participants' feedback on CBT1 test
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changzheng hospital
Study officials:
affiliation: Shanghai Changzheng Hospital
name: Lvping Sun
role: STUDY_CHAIR
References: