A UK wide multi-centre study titled ‘Beta Blockers or Placebo for Primary Prophylaxis of oesophageal varices’ or the BOPPP Trial has been funded by the National Institute for Health Research and is being supported by the British Liver Trust.
Liver disease is the fifth commonest cause of death in the developed world and is rising in incidence, with liver failure a common mode of death. In England and Wales, it is estimated that 60,000 people have cirrhosis with approximately 11,000 attributable deaths each year. In many cases patients are first diagnosed when they come to hospital with internal bleeding from oesophageal varices, which occurs unpredictably requiring emergency treatment, and leading to the need for intensive care admission. These may be life-ending if not stoppable.
The National Institute of Health Research Health Technology Assessment (NIHR: HTA) programme have commissioned new research. They have confirmed £2.3 million funding to consent, treat and follow up 1,200 patients at 25 different hospitals across the UK. The trial will take 6 years to complete aiming to assess whether the risk of bleeding can be reduced. It has been met with great support from liver specialists across the UK as well as being endorsed by the British Liver Trust.
This study will address whether primary prophylaxis against future variceal haemorrhage with non-selective beta blockers (NSBB) is clinically and economically effective in patients with cirrhosis and small varices. Patients will be given a beta blocker (carvedilol) or placebo and followed for three years.
Dr. Vishal Patel and Dr. Mark McPhail from the Institute of Liver Sciences, King’s College Hospital jointly led the application in conjunction with the King’s College London Clinical Trials Unit (PI Dr. Ben Carter). Dr. Patel states “This is a huge opportunity for a potentially landmark study, and if effective could benefit the lives for ’000’s of patients with cirrhosis in the UK. We are looking forward to working with our colleagues across the UK to successfully deliver this trial”.
Dr. McPhail states “We predict a reduction in liver bleeding by almost 50% after three years of follow up with less hospital admissions”.
Our study will not only investigate if NSBB are effective, but how this can be managed effectively within the primary care setting. Dr. Harry Ahmed, an academic GP at Cardiff University states “I am delighted that this important trial is collaborating with primary care from the outset, to understand how NSBB can be safely titrated and managed in the community”.
Further details of the trial and how patients can get involved will be published on the British Liver Trust website and via our newsletter once the study is up and running. Sign up for our newsletter here