Clinical trial NCT04807803: Evaluation of Minimal Hepatic Encephalopathy in Patients With Cirrhosis and Portal Hypertension
Official title: Evaluation of Minimal Hepatic Encephalopathy in Patients With Cirrhosis and Portal Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cirrhosis
Portal Hypertension
Keywords: cirrhosis
portal hypertension
minimal hepatic encephalopathy
spontaneous portosystemic shunts
sarcopenia
myosteatosis
Lead sponsor: IHU Strasbourg
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of MHE in patients with cirrhosis and portal hypertension by serum ammonia analysis
timeFrame: Day 1
measure: Evaluation of MHE in patients with cirrhosis and portal hypertension by the psychometric hepatic encephalopathy score (PHES)
timeFrame: Day 1
measure: Evaluation of MHE in patients with cirrhosis and portal hypertension by the animal naming test (ANT)
timeFrame: Day 1
Secondary outcomes:
measure: Evaluation of the correlation between MHE and portal hypertension by the mean of blood test and abdominal imaging
timeFrame: 1 month
measure: Evaluation of the correlation between MHE and splenic congestion by elastography
timeFrame: Day 1
measure: Evaluation of the correlation between MHE and liver fibrosis by elastography
timeFrame: Day 1
measure: Evaluation of the correlation between MHE and sarcopenia by imaging
timeFrame: Day 1
measure: Evaluation of the correlation between MHE and myosteatosis by imaging
timeFrame: Day 1
measure: Evaluation of the neurologic assessment in patients diagnosed with MHE after 6 months of treatment by serum ammonia analysis
timeFrame: Month 7
measure: Evaluation of the neurologic assessment in patients diagnosed with MHE after 6 months of treatment by the psychometric hepatic encephalopathy score (PHES)
timeFrame: Month 7
measure: Evaluation of the neurologic assessment in patients diagnosed with MHE after 6 months of treatment by the animal naming test (ANT)
timeFrame: Month 7
Other outcomes:
Locations:
city: Colmar
country: France
facility: Service d'Hépato-Gastroentérologie, Hôpitaux Civils
city: Strasbourg
country: France
facility: Service d'Hépato-gastroentérologie, NHC
Study officials:
affiliation: Service d'Hépato-Gastroentérologie, NHC, Strasbourg
name: Simona TRIPON, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: