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

Hepatic Encephalopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06367127
• Other study ID #: Pingfanghu
• Status: Enrolling by invitation
• Start date: October 9, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Shanghai Changzheng Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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). 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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, dif?culty in comprehension).

Related Conditions & MeSH terms

• Brain Diseases
• Covert Hepatic Encephalopathy
• Hepatic Encephalopathy

Locations

Country	Name	City	State
China	Shanghai Changzheng hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Changzheng Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Participants' feedback on CBT1 test	Participnants will be asked to complete the questionnaire of the feedback on CBT1 test	2 minutes