Ground breaking research for liver patients could be the biggest trial of its type ever

A consultant liver physician at University Hospitals Birmingham NHS Foundation Trust has been awarded a £2.3 million research grant to lead a clinical trial as Chief Investigator.

Dr Dhiraj Tripathi will be heading up the ground breaking trial which aims to save lives and essential NHS funds. Currently, liver disease is the fifth biggest killer in the UK and deaths are amongst relatively young patients. A complication of diseases of the liver is internal bleeding, which if unstoppable, can be lethal or lead to prolonged intensive care treatment.

Dr Tripathi, who is also an Honorary Reader at the University of Birmingham, welcomed the funding from the National Institute of Health Research (NIHR). He said: “CALIBRE (Carvedilol versus variceal band ligation in primary prevention of variceal bleeding in liver cirrhosis) 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 clinical trial will be co-ordinated through the Birmingham Clinical Trials Unit (BCTU) based 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 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 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).