Why this study?
Cirrhosis or liver scarring is an important healthcare problem in the UK. There are many ways in which patients with a severe form of liver disease become unwell or die and bleeding from the oesophagus or stomach is one.
Cirrhosis causes pressure changes inside the abdomen and swelling of veins in the oesophagus (called “varices”) which can bleed leading to hospitalisation and can also be fatal. We know that when varices are large, we need to treat them with a medication called beta-blockers to reduce the pressure in the varices. If the varices are small, we do not know which treatment is best and BOPPP will address this uncertainty.
The patient’s role:
Patients with small varices who are recruited to BOPPP will be randomised to either beta-blockers or a placebo. We will observe patients closely for 3 years for bleeding, other complications of cirrhosis and side effects of taking this medication. 3 years is needed to observe for bleeding when the varices are small. We will follow up with patients at standard of care intervals of every 6 months including assessing the varices by a camera test called an endoscopy at the beginning of the Clinical Trial and each year until the Trial is finished.
What are the outcomes of this trial?
We will measure the impact of beta-blockers on the overall costs to the NHS of caring for people with cirrhosis during the Trial. We will then assess the impact of treatment on mortality and quality of life using patients questionnaires. We will assess whether any increased costs are justified by better outcomes for patients and represent good value for money for the NHS budget.
What happens upon completion of the trial?
Once the BOPPP Trial has been completed, we will publish the results in the medical literature and discuss the findings at medical conferences, patient groups and with charities involved in helping patients with cirrhosis such as the British Liver Trust.