Status:
RECRUITING
Evaluation of Minimal Hepatic Encephalopathy in Patients With Cirrhosis and Portal Hypertension
Lead Sponsor:
IHU Strasbourg
Conditions:
Cirrhosis
Portal Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 25 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04807803
Start Date
March 26 2021
End Date
March 25 2025
Last Update
January 5 2024
Active Locations (2)
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1
Service d'Hépato-Gastroentérologie, Hôpitaux Civils
Colmar, France, 68024
2
Service d'Hépato-gastroentérologie, NHC
Strasbourg, France, 67000