Evaluating cognitive impairment in patients with liver disease and high blood pressure in the portal vein
Evaluation of Minimal Hepatic Encephalopathy in Patients With Cirrhosis and Portal Hypertension
NA · IHU Strasbourg · NCT04807803
This study is testing how common subtle thinking problems are in people with liver disease and high blood pressure in the portal vein, and it will also see if treating these problems makes a difference after six months.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IHU Strasbourg (other) |
| Locations | 2 sites (Colmar and 1 other locations) |
| Trial ID | NCT04807803 on ClinicalTrials.gov |
What this trial studies
This study focuses on minimal hepatic encephalopathy (MHE), a subtle cognitive impairment that often occurs in patients with cirrhosis and portal hypertension. It aims to assess the prevalence of MHE in these patients and explore the relationship between spontaneous portosystemic shunts and MHE. Participants will undergo various cognitive tests and assessments, including serum ammonia levels and psychometric evaluations, to determine the presence of MHE. Those diagnosed with MHE will receive treatment and be re-evaluated after six months to assess any changes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with compensated cirrhosis and portal hypertension who have undergone recent imaging studies.
Not a fit: Patients with overt hepatic encephalopathy or significant neurological disorders are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and management of cognitive impairments in patients with liver disease, enhancing their quality of life.
How similar studies have performed: While the relationship between spontaneous portosystemic shunts and MHE is not well understood, similar studies have indicated that addressing MHE can significantly impact patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Colmar and 1 other locations
- Service d'Hépato-Gastroentérologie, Hôpitaux Civils — Colmar, France (NOT_YET_RECRUITING)
- Service d'Hépato-gastroentérologie, NHC — Strasbourg, France (RECRUITING)
Study contacts
- Principal investigator: Simona TRIPON, MD, PhD — Service d'Hépato-Gastroentérologie, NHC, Strasbourg
- Study coordinator: Armelle TAKEDA, PhD
- Email: armelle.takeda@ihu-strasbourg.eu
- Phone: +33 390413608
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cirrhosis, Portal Hypertension, cirrhosis, portal hypertension, minimal hepatic encephalopathy, spontaneous portosystemic shunts, sarcopenia, myosteatosis