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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Hepatic Encephalopathy; Covert Hepatic Encephalopathy

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Changzheng Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants' feedback on CBT1 test	Participnants will be asked to complete the questionnaire of the feedback on CBT1 test	2 minutes

Collaborators and Investigators

• Sponsor: Shanghai Changzheng Hospital
• Investigators: Study Chair: Lvping Sun, Shanghai Changzheng Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 15, 2024
• First Submitted That Met QC Criteria: April 14, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 14, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Liver Diseases; Brain Diseases, Metabolic; Hepatic Encephalopathy; Brain Diseases
• Other Study ID Numbers: Pingfanghu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No