Utility of the Clamping Bean Test (CBT) for Covert Hepatic Encephalopathy Screening

NCT ID: NCT06367127

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-09
• Study Completion Date: 2024-12-31

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.

Conditions

Hepatic Encephalopathy; Covert Hepatic Encephalopathy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Changzheng Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lvping Sun

Role: STUDY_CHAIR

Shanghai Changzheng Hospital

Locations

Shanghai Changzheng hospital

Shanghai, , China

Countries

China

Other Identifiers

Pingfanghu

Identifier Type: -

Identifier Source: org_study_id