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

NCT04807803 | Completed

• 1 other identifier: 19-010
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

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.

Conditions

Cirrhosis; Portal Hypertension

Keywords

cirrhosis; portal hypertension; minimal hepatic encephalopathy; spontaneous portosystemic shunts; sarcopenia; myosteatosis

Outcome Measures

Primary Outcomes (3)

• Evaluation of MHE in patients with cirrhosis and portal hypertension by serum ammonia analysis

  The serum ammonia analysis measures the level of ammonia in the blood, expressed in micromoles per liter. Average values in venous blood are between 11,2 and 48,2 micromoles per liter.

  Day 1

• Evaluation of MHE in patients with cirrhosis and portal hypertension by the psychometric hepatic encephalopathy score (PHES)

  The psychometric hepatic encephalopathy score (PHES) is composed of five tests, number connection test-A (NCT-A), number connection test-B (NCT-B), serial dotting test (SDT), line tracing test (LTT) and digit symbol test (DST). The results of the NCT-A, NCT-B, and SDT were measured as seconds, including the time needed to correct any errors, and the result of DST was measured as points. The results of the LTT were measured as both the time needed to complete the test (LTTt, seconds) and as the error score (LTTe), LTT = (1 + LTTe/100) × LTTt. Accordingly, a higher result of DST equals better performance, and lower results on the other tests equal better performance. The final score of PHES is generated from the sum of the scores of five tests, which ranged between +5 and -15. The result of the PHES is expressed in number of standard deviations (SD) from a population matched on age and level of education. A threshold (- 4DS) defines the EHM according to current recommendations.

  Day 1

• Evaluation of MHE in patients with cirrhosis and portal hypertension by the animal naming test (ANT)

  The animal naming test (ANT) is an analysis of semantic fluency consisting of saying as many animal names as possible within one minute. The French recommendations developed by the French Association for The Liver Study (AFEF) suggests a limit of 20 animal names in 1 min. Below, the existence of MHE is likely.

  Day 1

Secondary Outcomes (8)

• Evaluation of the correlation between MHE and portal hypertension by the mean of blood test and abdominal imaging

  1 month

• Evaluation of the correlation between MHE and splenic congestion by elastography

  Day 1

• Evaluation of the correlation between MHE and liver fibrosis by elastography

  Day 1

• Evaluation of the correlation between MHE and sarcopenia by imaging

  Day 1

• Evaluation of the correlation between MHE and myosteatosis by imaging

  Day 1

Study Arms (1)

Patients with compensated cirrhosis and portal hypertension

EXPERIMENTAL

Diagnostic Test: Assessment of Minimal hepatic encephalopathy (MHE)

Interventions

Assessment of Minimal hepatic encephalopathy (MHE) DIAGNOSTIC_TEST

Assessment of MHE at the inclusion and 6 months after treatment if diagnosed with MHE: Serum ammonia analysis, psychometric hepatic encephalopathy score (PHES), animal naming test (ANT) and evaluation of abdominal imaging, liver and splenic transient elastography, gastroscopy

Patients with compensated cirrhosis and portal hypertension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 under guardianship, trusteeship or the protection of justice or incapable of giving their own informed consent

Sponsors & Collaborators

• IHU Strasbourg: lead

Study Sites (2)

Service d'Hépato-Gastroentérologie, Hôpitaux Civils

Colmar, 68024, France

Location

Service d'Hépato-gastroentérologie, NHC

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Fibrosis; Hypertension, Portal; Sarcopenia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Simona TRIPON, MD, PhD

  Service d'Hépato-Gastroentérologie, NHC, Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 19, 2021
• Study Start: March 26, 2021
• Primary Completion: March 24, 2025
• Study Completion: March 24, 2025
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)