B-SMaRT Study

Introduction

Researchers in Nottingham have shown MRI can be used as an accurate marker of portal pressure with just one scan. To be useful to patients, doctors and researchers, this study will investigate whether MRI can detect meaningful changes in portal pressure after treatment with beta-blockers.

All patients who have HVPG will be given information about the study.

​Study aim

To test if MRI can detect meaningful changes in portal pressure in the liver to assess whether treatment with beta-blockers has worked

Liver Disease

Most people with liver disease do not have symptoms. Over time they develop ‘cirrhosis’ - severe liver scarring. In the UK, deaths due to cirrhosis have doubled over the last decade, because of increasing rates of alcohol consumption and obesity, while heart, kidney, lung diseases, strokes and cancer fatalities have fallen.

Portal Pressure

Cirrhosis causes increased pressure within the liver and changes in the circulation leading to the development of varicose veins in the gullet and stomach called ‘varices’. Varices bleed easily, leading to emergency situations that can be life threatening. However, if the increased pressure within the liver (portal pressure) is detected early, then treatment can prevent variceal bleeding. The only test we have to predict prognosis and treatment success in someone with cirrhosis is by measuring the portal pressure. Currently the only existing test to measure portal pressure is to pass a pressure sensor through a vein in the neck, down into the liver. This is called the hepatic venous pressure gradient (HVPG) measurement.

How can you treat varices?

Two options;

  1. With tablets to lower the pressure (beta-blockers)
  2. Endoscopy treatment (banding)

Both have advantages and disadvantages;

  • Beta-blockers only lower the portal pressure in about half of those that take them, with some evidence they may also have a protective effect against infections from the bowel by increasing the speed of bowel motion
  • Treating the varices with endoscopy requires several endoscopies and can lead to life-threatening bleeding.

Most patients are therefore given beta-blockers and monitored closely to see if they work.

Who can participate?

  • Men & women aged 18 - 85 and able to give informed consent
  • Must have had portal pressure measurements within the last 6 weeks (usually as part of a transjugular liver biopsy)
  • Must have chronic liver disease caused by any of the following: alcoholic liver disease (ALD), non-alcoholic fatty liver disease (NAFLD), chronic hepatitis B or C and haemochromatosis.
  • No known reason why you cannot start beta-blockers

Participation involves:

Study Visit 1

Starts at the Nottingham Biomedical Research Centre (“BRC”) in QMC (lasts about 2.5 hours)

  • Complete consent form
  • One hour MRI scan
  • Endoscopy to identify varices

If varices are present the patient will be started on beta-blockers and invited to visit 2

If there are no varices, patients will return to regular follow up with the liver team.

Study Visit 2

(after one week) – at the “BRC” (lasts about 10 mins)

  • Assess side effects, blood pressure and pulse
  • Increase dose of beta-blocker as appropriate

Study Visit 3

(after 4-12 weeks) – starts at the “BRC” (lasts about 2.5 hours)

  • One hour MRI scan
  • Repeat HVPG measurement

Treatment success is determined by the second HVPG measurement. If beta-blockers are working they will be continued. If not, you will have treatment with endoscopy. This represents the ideal pathway which is more personalised than current stanard care.

Study contacts

Dr Robert Scott, Research Fellow, rob.scott@nottingham.ac.uk

Dr Naaventhan Palaniyappan, Assistant Professor, msznp1@nottingham.ac.uk

Shellie Radford, Senior Research Nurse, shellie.radford@nuh.nhs.uk

Jan Hallas, Research Nurse, jan.hallas@nuh.nhs.uk

Bethany Robinson, Personal Assistant & Research Administrator to Professor Guru Aithal, bethany.robinson@nottingham.ac.uk

Tel: 0115 9709966

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