Hepatic Encephalopathy Clinical Trial
Official title:
Role of Magnetic Resonance Imaging in Detection of Minimal Hepatic Encephalopathy
Introduction Liver cirrhosis (LC) is irreversible fibrosis of the liver (1) and it remains a
public health problem. One of the complications of the cirrhosis is hepatic encephalopathy
(HE) which is defined as brain dysfunction caused by liver insufficiency. Pathophysiological
mechanisms of HE are complex and multifactorial. Recognition of beginning stages of HE, such
as minimal HE (mHE) is of most importance.
Objectives and originality of the project Diagnosis of mHE can be challenging, time-consuming
and, at least to some extent, subjective. This project will assess the role of magnetic
resonance (MR) in mHE diagnosis with emphasis on multimodal imaging technique. With advanced
magnetic resonance (MR) techniques, in-vivo detection of intracellular water content,
estimation pH and metabolites levels with millimolar concentrations can be easily performed.
This will offer to explore possible pathophysiological mechanisms of HE and to evaluate the
results from previous, studies that were mainly performed on animal models or cell cultures.
By our best knowledge, multimodal MR approach as the investigators propose in this
application has not been yet performed. The investigators will use advanced MR techniques
which are currently not available in the clinical setting and require multicenter
collaboration.
Methods The investigators will include 10-20 patients of both genders with hyperammonemia and
mHE and 10-20 patients of both genders with HE. Diagnosis of HE will be made based on results
of validated neuropsychiatric test. Age-matched and gender-matched control group with no
gastrointestinal, neurological or psychiatric complaints and normal levels of ammonia in the
blood. Patients with mHE/HE will be included from outpatient clinic of the Department of
gastroenterology, University Medical Centre (UMC) Ljubljana. Healthy controls (HC) will be
invited to join via internet advertisement. Contraindications for HC will include
gastrointestinal (emphasis on liver disease), neurological or psychiatric complaints. Grade
of mHE/HE will be classified according to West-Haven (WH) classification. Patients with
different degree of liver cirrhosis, which will be scored with the Child-Pugh (CP) score, and
with no contraindications for MR (e.g. presence of metal in body) will be included. Blood
levels of liver enzymes and ammonia will be measured in all participants. MR scanning will
include: T1- and T2-weighted MR, MRS (MEGA-PRESS and PRESS) in two voxels: striatum and
cerebellum. Location will be double-checked by voxel position screenshots. Analysis, with
voxel-positioning error compensation will be performed in Gannet (www.gabamrs.com). Moreover,
high resolution diffusion weighted imaging (DWI), diffusion kurtosis imaging (DKI),
quantitative susceptibility mapping (QSM) will be performed in brain as well. Liver QSM will
be executed to assess iron load.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01559519 -
Post Transjugular Intrahepatic Portosystemic Shunt (Tips) Albumine Infusion to Prevent Hepatic Encephalopathy
|
Phase 4 | |
Terminated |
NCT01846806 -
The Role of Bacterial Overgrowth and Delayed Intestinal Transit in Hepatic Encephalopathy.
|
N/A | |
Recruiting |
NCT01178372 -
Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis
|
Phase 4 | |
Completed |
NCT00740142 -
Efficacy of Combined Oral L-ornithine-L-aspartate and Lactulose in Patients With Hepatic Encephalopathy
|
Phase 4 | |
Completed |
NCT00914056 -
A Study of Controlled Lactulose Withdrawal
|
N/A | |
Completed |
NCT00558038 -
Safety and Efficacy of AST-120 Compared to Lactulose in Patients With Hepatic Encephalopathy
|
Phase 2 | |
Completed |
NCT00986895 -
A Study of Glyceryl Tri-(4-phenylbutyrate) Administered Orally as a Single Dose, and Twice Daily for Seven Consecutive Days to Subjects With Hepatic Impairment With Cirrhosis and to a Control Group
|
Phase 1 | |
Completed |
NCT00287235 -
Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS)
|
N/A | |
Recruiting |
NCT05539027 -
Efficacy of L-Ornithine L-Aspartate (LOLA) as an Adjunct to Branched Chain Amino Acids (BCAA) Enriched Solutions on Clinical Outcomes in ICU Patients With Hepatic Encephalopathy
|
Phase 4 | |
Recruiting |
NCT04096014 -
Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy
|
N/A | |
Completed |
NCT05526404 -
Prevention of Hepatic Encephalopathy With Mobile Application Based Lactulose Titration
|
N/A | |
Completed |
NCT04082780 -
Rifamycin in Minimal Hepatic Encephalopathy
|
Phase 2 | |
Enrolling by invitation |
NCT06367127 -
Utility of the Clamping Bean Test (CBT) for Covert Hepatic Encephalopathy Screening
|
||
Active, not recruiting |
NCT05425316 -
Speech in Hepatic Encephalopathy (HE)
|
||
Recruiting |
NCT04415294 -
Flicker App for Minimal Hepatic Encephalopathy
|
||
Not yet recruiting |
NCT06072521 -
Efficacy of Lactoferrin as an Adjunct Therapy in Patients With Hepatic Encephalopathy
|
Phase 2 | |
Completed |
NCT02636647 -
Fecal Transplant in Recurrent Hepatic Encephalopathy
|
Phase 1 | |
Withdrawn |
NCT02086825 -
A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Renal Failure
|
Phase 3 | |
Completed |
NCT01446523 -
S. Endotoxin, Inflammatory Mediators and MRS Before and After Treatment in MHE
|
N/A | |
Completed |
NCT01218568 -
Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial
|
N/A |