The University of Birmingham will play a leading role in a new £2.3 million clinical trial aimed at improving treatment to prevent potentially deadly bleeding in patients with liver cirrhosis.
The CALIBRE (carvedilol versus variceal band ligation in primary prevention of variceal bleeding in liver cirrhosis) trial is understood to be the largest of its kind, and 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 among relatively young patients. 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 the Birmingham Clinical Trials Unit at the University of Birmingham, under the leadership of its director, Professor Peter Brocklehurst.
Professor Brocklehurst said: “This is a large trial that 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 to patients, but a large high quality trial to assess which has the best result has not been tried before.
Dr Tripathi also acknowledged important contributions from expert co-applicants in the hepatological field at 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).