Portal HypertensionMRQueeNCT01756859
MRI in Portal Hypertension
An observational study of Portal Hypertension, run by University of Nottingham at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Portal Hypertension
- What is being tested?
- MRI Scan
- Type of treatment
- Surgery or procedure
- How many people
- 49 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2013to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients of more than 18 years of age.
- Patients who have had HVPG measurements within the last 6 weeks.
- Underlying portal hypertension due to chronic liver disease - alcoholic liver disease, non-alcoholic fatty liver disease (NAFLD), chronic hepatitis B or C and heamochromatosis.
- Patients investigated with a clinical suspicion of portal hypertension, but have normal portal pressures on HVPG measurements.
- Ability to consent to participate in the study.
Who cannot join
- Patients with underlying diseases which are NOT related to alcohol excess, NAFLD, chronic hepatitis B, C or haemochromatosis.
- Abdominal/waist circumference greater than 112 cm (44 inches) due to scanner bore constraints
- Pregnant women.
- 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.
Trial locations and contacts
2 sites in 1 country.
Naaventhan Palaniyappan contact
United Kingdom2 sites, 2 recruiting
- Recruiting
Royal Derby Hospitals
Derby, Derby
Naaventhan Palaniyappan, n.palaniyappan@nottingham.ac.uk
Andrew Austin
- Recruiting
Nottingham University Hospitals NHS Trust
Nottingham, Nottingham, NG72UH
Naaventhan Palaniyappan, n.palaniyappan@nottingham.ac.uk
Naaventhan Palaniyappan
About this study
Official title: Quantitative Magnetic Resonance Imaging (MRI) Techniques in the Evaluation and Estimation of Portal Hypertension
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.
- Conditions
- Portal Hypertension
- Being tested
- MRI Scan
- Keywords
- Portal hypertension, HVPG, MRI
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI ScanProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients with HVPG measurements | Patients having HVPG measurements for clinical reasons will be recruited to undergo research MRI scan. Receives: Procedure: MRI Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of quantitative MR techniques in the detection and grading the degree of portal hypertension compared to HVPG measurements.
Measured: 18 months
Secondary outcomes (2)
Correlation between quantitative MR techniques and serum biomarkers of fibrosis.
Measured: 18 months
Characterisation of the gut microbiota in patients with portal hypertension.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guruprasad Aithal, Principal investigator, NIHR Biomedical Research Unit in Gastrointestinal and Liver Diseases, Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756859
- Sponsor's protocol ID
- 12092
- Acronym
- MRQuee
- Status last verified
- Jan 2014
- First submitted
- 20 Dec 2012
- Last updated
- 15 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Magnetic Resonance Imaging (MRI) Techniques in the Evaluation and Estimation of Portal Hypertension
- ClinicalTrials.gov ID
- NCT01756859
- Acronym / sponsor ID
- MRQuee / 12092
- Conditions
- Portal Hypertension
- Keywords
- Portal hypertension, HVPG, MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2014 (estimated)
- First posted
- 28 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with HVPG measurements | – | Procedure: MRI ScanPatients having HVPG measurements for clinical reasons will be recruited to undergo research MRI scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Patients of more than 18 years of age.
- Patients who have had HVPG measurements within the last 6 weeks.
- Underlying portal hypertension due to chronic liver disease - alcoholic liver disease, non-alcoholic fatty liver disease (NAFLD), chronic hepatitis B or C and heamochromatosis.
- Patients investigated with a clinical suspicion of portal hypertension, but have normal portal pressures on HVPG measurements.
- Ability to consent to participate in the study.
Key exclusion criteria (4 listed)
- Patients with underlying diseases which are NOT related to alcohol excess, NAFLD, chronic hepatitis B, C or haemochromatosis.
- Abdominal/waist circumference greater than 112 cm (44 inches) due to scanner bore constraints
- Pregnant women.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI Scan | Procedure or surgery | Patients with HVPG measurements |
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
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naaventhan Palaniyappan contact
Guruprasad Aithal principal investigator
NIHR Biomedical Research Unit in Gastrointestinal and Liver Diseases, Nottingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Portal Hypertension, run by University of Nottingham at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naaventhan Palaniyappan (n.palaniyappan@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of quantitative MR techniques in the detection and grading the degree of portal hypertension compared to HVPG measurements. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2014.