MRI in Portal Hypertension (MRQuee)

This study is currently recruiting participants.
Verified January 2014 by University of Nottingham
Sponsor:
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01756859
First received: December 20, 2012
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Portal Hypertension
Procedure: MRI Scan

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Quantitative Magnetic Resonance Imaging (MRI) Techniques in the Evaluation and Estimation of Portal Hypertension

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Diagnostic accuracy of quantitative MR techniques in the detection and grading the degree of portal hypertension compared to HVPG measurements. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation between quantitative MR techniques and serum biomarkers of fibrosis. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Characterisation of the gut microbiota in patients with portal hypertension. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood, urine and stool samples.


Estimated Enrollment: 49
Study Start Date: January 2013
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with HVPG measurements
Patients having HVPG measurements for clinical reasons will be recruited to undergo research MRI scan.
Procedure: MRI Scan

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756859

Contacts
Contact: Naaventhan Palaniyappan n.palaniyappan@nottingham.ac.uk

Locations
United Kingdom
Royal Derby Hospitals Recruiting
Derby, United Kingdom
Contact: Naaventhan Palaniyappan       n.palaniyappan@nottingham.ac.uk   
Principal Investigator: Andrew Austin         
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom, NG72UH
Contact: Naaventhan Palaniyappan       n.palaniyappan@nottingham.ac.uk   
Sub-Investigator: Naaventhan Palaniyappan         
Sponsors and Collaborators
University of Nottingham
Investigators
Principal Investigator: Guruprasad Aithal NIHR Biomedical Research Unit in Gastrointestinal and Liver Diseases, Nottingham
  More Information

Additional Information:
No publications provided

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01756859     History of Changes
Other Study ID Numbers: 12092
Study First Received: December 20, 2012
Last Updated: January 14, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Nottingham:
Portal hypertension
HVPG
MRI

Additional relevant MeSH terms:
Hypertension
Hypertension, Portal
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014