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

Last updated: January 4, 2024
Sponsor: IHU Strasbourg
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hepatic Encephalopathy

Hepatic Fibrosis

Vomiting

Treatment

Assessment of Minimal hepatic encephalopathy (MHE)

Clinical Study ID

NCT04807803
19-010
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 andof giving his written informed consent.
  • Patient affiliated to the French social security system

Exclusion

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 ofgiving their own informed consent

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Assessment of Minimal hepatic encephalopathy (MHE)
Phase:
Study Start date:
March 26, 2021
Estimated Completion Date:
March 25, 2025

Study 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.

Connect with a study center

  • Service d'Hépato-Gastroentérologie, Hôpitaux Civils

    Colmar, 68024
    France

    Site Not Available

  • Service d'Hépato-gastroentérologie, NHC

    Strasbourg, 67000
    France

    Active - Recruiting

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