Clinical trial NCT01756859: MRI in Portal Hypertension
Official title: Quantitative Magnetic Resonance Imaging (MRI) Techniques in the Evaluation and Estimation of Portal Hypertension
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Portal Hypertension
Keywords: Portal hypertension
HVPG
MRI
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2012-12-28
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited from liver services from Nottingham University Hospitals NHS Trust and Derby Hospitals NHS Foundation Trust. All the patients will have had HVPG measurements performed for clinical indications.

Brief summary: Death from chronic liver disease has doubled in the UK over the last decade. This is largely due to the rise in liver disease from excess alcohol consumption, obesity related fatty liver disease and hepatitis B \& C infections. The current 'liver tests' only identify liver injury when the damage is at an advanced stage. They neither estimate the degree of injury accurately nor help judge prognosis. The complications from chronic liver disease result mainly from raised pressures within the liver. We currently measure this pressure by passing a long catheter through the jugular vein in the neck into the liver. This invasive test does carry a small yet significant risk of complications and is not available outside specialised liver centres. Raised pressure within the liver is also associated with changes in the microorganisms within the gut. This leads to increased infective complications among patients with liver cirrhosis.

We aim to noninvasively measure the pressures within the liver using Magnetic Resonance Imaging (MRI). We will recruit 49 patients with chronic liver disease who have had liver pressure measurements as part of their routine clinical assessment. The participants will attend the Biomedical Research Unit and the MR Centre for a single 2hour visit. We will also collect blood, urine and stool samples from them.

The diagnostic accuracy of the quantitative MRI techniques will be validated against the pressures obtained via the invasive test. The quantitative MRI techniques will also correlated with biomarkers of liver injury obtained from blood and urine samples. The stool sample obtained will be used to characterise the gut microorganisms in these patients.


Eligibility criteria: Inclusion Criteria:

1. Patients of more than 18 years of age.
2. Patients who have had HVPG measurements within the last 6 weeks.
3. Underlying portal hypertension due to chronic liver disease - alcoholic liver disease, non-alcoholic fatty liver disease (NAFLD), chronic hepatitis B or C and heamochromatosis.
4. Patients investigated with a clinical suspicion of portal hypertension, but have normal portal pressures on HVPG measurements.
5. Ability to consent to participate in the study.

Exclusion Criteria:

1. Patients with underlying diseases which are NOT related to alcohol excess, NAFLD, chronic hepatitis B, C or haemochromatosis.
2. Abdominal/waist circumference greater than 112 cm (44 inches) due to scanner bore constraints
3. Pregnant women.
4. Absolute contraindications for MRI. Any patient that indicates on the MR safety questionnaire that they have or suspect they may have metal in their eye(s) will require an x-ray prior to their MRI scan confirming that their eye(s) are free from metal. This will be verified using previous x-ray records. Any patient whose previous records indicate that they may have had metal in their eye(s) or any patients without any x-ray records will be x-rayed for the purposes of this study. Any patient having current metal in their eye(s), will not be given an MRI scan and therefore will not be recruited into the study.

Primary outcomes:
measure: Diagnostic accuracy of quantitative MR techniques in the detection and grading the degree of portal hypertension compared to HVPG measurements.
timeFrame: 18 months
Secondary outcomes:
measure: Correlation between quantitative MR techniques and serum biomarkers of fibrosis.
timeFrame: 18 months
measure: Characterisation of the gut microbiota in patients with portal hypertension.
timeFrame: 18 months
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: Royal Derby Hospitals
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
affiliation: NIHR Biomedical Research Unit in Gastrointestinal and Liver Diseases, Nottingham
name: Guruprasad Aithal
role: PRINCIPAL_INVESTIGATOR
References: