Evaluation of Minimal Hepatic Encephalopathy in Patients With Cirrhosis and Portal Hypertension (Evencipor)

IHU Strasbourg

Status

Enrolling

Conditions

Portal Hypertension

Cirrhosis

Treatments

Diagnostic Test: Assessment of Minimal hepatic encephalopathy (MHE)

Study type

Interventional

Funder types

Other

Identifiers

NCT04807803

19-010

Details and patient eligibility

About

Minimal hepatic encephalopathy (MHE) is a subclinical cognitive impairment and represents the mildest type of hepatic encephalopathy (HE). Portal hypertension is the main complication of cirrhosis and is responsible of severe complications such as HE. The consequence of portal hypertension is the formation of the spontaneous portosystemic shunts (SPSS). The relationship between the SPSS and their characteristics and the prevalence of MHE in patient with cirrhosis is poorly known. The main objective of this study is to evaluate the MHE in patients with cirrhosis and portal hypertension.

Full description

Minimal hepatic encephalopathy (MHE) is a subclinical cognitive impairment and represents the mildest type of hepatic encephalopathy (HE). It is a frequent complication of the liver disease, affecting up to 80% of tested patients. MHE affects severely the lives of patients by altering their quality-of-life and their socioeconomic status and is strongly associated to the development of overt HE. Portal hypertension is the main complication of cirrhosis and is responsible of severe complications such as HE. The consequence of portal hypertension is the formation of the spontaneous portosystemic shunts (SPSS). Their presence has been associated with recurrent or persistent HE. The relationship between the SPSS and their characteristics and the prevalence of MHE in patient with cirrhosis is poorly known.

Patients with compensated cirrhosis and portal hypertension will be considered for inclusion. After written inform consent, the serum ammonia, psychometric hepatic encephalopathy score (PHES) and the animal naming test (ANT) will be performed to evaluate the presence of MHE. Patients diagnosed with MHE will be treated and a new evaluation will be performed 6 months later.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient with cirrhosis and portal hypertension older than 18 old
Patient who underwent a CT scan or MRI in the last 3 months
The Mini-Mental State (MMS) test >25.
Patient capable of receiving and understanding information relating to the study and of giving his written informed consent.
Patient affiliated to the French social security system

Exclusion criteria

Cirrhotic patient with overt HE or history of persistent or recurrent HE.
Hepatocellular carcinoma beyond Milan criteria.
Portal vein thrombosis.
Previous transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunt.
Presence of neurological or psychiatric disorder.
Patient with treatment by benzodiazepines or opioid substitution.
Pregnant or nursing women
Patient in exclusion period of a previous study
Patient under guardianship, trusteeship or the protection of justice or incapable of giving their own informed consent