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

• Conditions: Hepatic Encephalopathy; Covert Hepatic Encephalopathy

• Registration Number: NCT06367127
• Lead Sponsor: Shanghai Changzheng Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-09
• Status Verified: 2024-01
• Study First Submitted: 2024-01-15
• Study First Submitted QC: 2024-04-14
• Last Update Submitted: 2024-04-14
• Study First Posted: 2024-04-16
• Last Update Posted: 2024-04-16
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Beans Clamping in 1 minute	1 minute	Moving beans from one container to another with tweezers in one minute, and then count the number of beans

Secondary Outcome Measures

Name	Time	Method
Participants' feedback on CBT1 test	2 minutes	Participnants will be asked to complete the questionnaire of the feedback on CBT1 test

Trial Locations

Locations (1)

Shanghai Changzheng hospital; 🇨🇳 Shanghai, China