UK wide multi-centre study:
Beta Blockers or Placebo for Primary Prophylaxis of oesophageal varices (BOPPP Trial).
Funded by the NIHR: HTA Programme
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 present with internal bleeding from oesophageal varices, which occurs unpredictably requiring emergency treatment, and leading to the need for intensive care admission and may be life-ending if not stoppable.
The National Institute of Health Research Health Technology Assessment (NIHR: HTA) programme commissioned this research and has confirmed that it will fund £2.3 million 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, the national body representing patients with cirrhosis.
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”.