£2.3m clinical trial to improve treatment of liver cirrhosis

The University of Birmingham will play a leading role in a new £2.3m clinical trial aimed at improving treatment to prevent potentially deadly bleeding in people with liver cirrhosis.

The University of Birmingham understands the CALIBRE (Carvedilol versus variceal band ligation in primary prevention of variceal bleeding in liver cirrhosis) trial is to be the largest of its kind. It has been funded by the National Institute of Health Research (NIHR).

Currently, liver disease is the fifth biggest killer in the UK and deaths are amongst relatively young people. A complication of diseases of the liver is internal bleeding which, if unstoppable, can be deadly or can lead to prolonged intensive care treatment.

Trial Chief Investigator Dr Dhiraj Tripathi, a consultant liver physician at University Hospitals Birmingham NHS Foundation Trust and Honorary Reader at the University of Birmingham, said “CALIBRE has the potential to be the largest ever clinical trial of its kind in the history of hepatology in the UK. The trial is to be rolled out nationally and all hospitals with gastroenterology and hepatology services, as well as research facilities, are eligible to participate. The results could lead to a major shift in the management of patients with liver cirrhosis and varices, with significant implications for the NHS.”

The trial will be co-ordinated by Birmingham Clinical Trials Unit at the University of Birmingham, under the leadership of its director Professor Peter Brocklehurst, who said “This is a large trial which needs to recruit over 2,600 patients, which will make it the largest trial carried out in the UK involving patients with liver disease. There is fantastic support for this trial from liver specialists throughout the UK and we are very optimistic that it will help us to find an answer to this really important research question in about six years’ time.”

The trial will compare two different approaches to preventing potentially deadly bleeding from enlarged internal blood vessels (varices) in patients with liver cirrhosis. One treatment involves administering a drug and the other is an endoscopic treatment to the areas likely to bleed. Both treatments are currently offered, but a large high quality trial to assess which has the best result has not been tried before.

The trial is an example of research being carried out by Birmingham Health Partners (BHP), a strategic alliance between the University of Birmingham, University Hospitals Birmingham NHS Foundation Trust and Birmingham Women’s and Children’s NHS Foundation Trust. BHP’s mission is to harness research strengths between the University of Birmingham and the NHS to deliver better treatments and care.

Dhiraj Tripathi also acknowledged important contributions from expert co-applicants in the haepatological field at the University Hospitals Birmingham (Dr James Ferguson), University of Edinburgh (Professor Peter Hayes), University of Leeds (Dr Ian Rowe) and the Royal Liverpool Hospital (Dr Paul Richardson). There has also been considerable patient and public involvement and support from the British Society of Gastroenterology (BSG) and British Association for the Study of the Liver (BASL).

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