Clinical Trial: MRI in Portal Hypertension
Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Observational
Official Title: Quantitative Magnetic Resonance Imaging (MRI) Techniques in the Evaluation and Estimation of Portal Hypertension
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.
Detailed Summary:
Sponsor: University of Nottingham
Current Primary Outcome: Diagnostic accuracy of quantitative MR techniques in the detection and grading the degree of portal hypertension compared to HVPG measurements. [ Time Frame: 18 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Correlation between quantitative MR techniques and serum biomarkers of fibrosis. [ Time Frame: 18 months ]
- Characterisation of the gut microbiota in patients with portal hypertension. [ Time Frame: 18 months ]
Original Secondary Outcome: Same as current
Information By: University of Nottingham
Dates:
Date Received: December 20, 2012
Date Started: January 2013
Date Completion:
Last Updated: January 14, 2014
Last Verified: January 2014
