Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
49 participants
OBSERVATIONAL
2013-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Patients with HVPG measurements
Patients having HVPG measurements for clinical reasons will be recruited to undergo research MRI scan.
MRI Scan
Interventions
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MRI Scan
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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University of Nottingham
OTHER
Responsible Party
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Principal Investigators
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Guruprasad Aithal
Role: PRINCIPAL_INVESTIGATOR
NIHR Biomedical Research Unit in Gastrointestinal and Liver Diseases, Nottingham
Locations
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Royal Derby Hospitals
Derby, Derby, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, Nottingham, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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12092
Identifier Type: -
Identifier Source: org_study_id
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