Beta-blockers or placebo for primary prophylaxis (BOPPP) Trial
Research type
Research Study
Full title
Beta Blockers or placebo for primary prophylaxis of oesophageal varices (BOPPP Trial). A blinded, multi-centre, clinical effectiveness and cost-effectiveness randomised controlled trial
IRAS ID
255446
Contact name
Vishal Patel
Contact email
Sponsor organisation
Kings College Hospital NHS Foundation Trust
Eudract number
2018-002509-78
ISRCTN Number
ISRCTN10324656
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 9 months, days
Research summary
Cirrhosis or liver scarring is an important healthcare problem in the United Kingdom. There are 60,000 patients living with this disease and about 11,000 people die every year due to complications of cirrhosis. Bleeding from the oesophagus or stomach is one of these complications. Cirrhosis causes pressure changes inside the abdomen and swelling of veins in the oesophagus (called “varices”) which can cause fatal bleeding.
Research has proven that large varices can be treated with beta-blockers (a type of anti-hypertensive medication) to reduce the pressure in the veins. The management of small varices is still uncertain. This study aims to discover if beta blockers can be used in this setting. We hypothesize that beta blockers will reduce the risk of bleeding from small varices from 20% to 10% over a period of 3 years, resulting in significant cost savings to the NHS from better patient outcomes.
The study will be opened in approximately 25 centres nationally. Patients with small volume varices, identified by routine endoscopy, will be randomised to receive either beta-blockers or a placebo. They will be followed up 6 monthly for a period of 3 years. We will assess for complications of cirrhosis (including bleeding) and medicine related side effects. The varices will be monitored annually by endoscope for the duration of the study. General practitioners will be involved in monitoring patients and adjusting doses.
As part of our analysis we will assess the impact of treatment on mortality and quality of life using a combined measure, the Quality Adjusted Life-Year (QALY). We will use a mathematical prediction model to estimate the impact of treatment on costs, mortality and quality of life over a patient’s lifetime; identifying if any increased costs are justified by better outcomes for patients and represent good value for money for the NHS budget.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
19/YH/0015
Date of REC Opinion
20 Mar 2019
REC opinion
Further Information Favourable Opinion