A King’s Liver Unit Consultant Hepatologist who was selected for the NIHR CRN South London Greenshoots programme has been awarded £2.3 million for a multi-centre clinical trial assessing drug therapy in portal hypertension and cirrhosis.
Dr Vishal Patel, a Honorary Consultant Hepatologist at King’s College Hospital NHS Foundation Trust who is taking part in the Greenshoots programme this year, has been awarded funding for the BOPPP Trial (Beta Blockers Or Placebo for Primary Prophylaxis of oesophageal varices), which aims to recruit 1,200 patients at 25 different hospitals across the UK and evaluate whether carvedilol, a non-selective beta-blocker, is an effective way to prevent variceal bleeding in cirrhotic patients, a well known and potentially devastating complication in these patients affected by chronic liver disease.
Liver disease is the fifth most common cause of death in the developed world and the incidence is rising. In England and Wales, it is estimated that 60,000 people have cirrhosis (‘scarring of the liver’) with approximately 11,000 attributable deaths each year. In some cirrhotic patients, the bleeding can occur from varicose veins that develop in the gullet which requires emergency treatment and can be fatal. Carvedilol may be a way of reducing the risk of this kind of bleeding.
Dr Patel said: “The question we are aiming to answer is whether this particular medication can prevent bleeding in patients with cirrhosis who have small oesophageal varices. With the idea being that if this treatment is started at an earlier stage of disease, it may prevent this sort of serious complication.”
Funding of £2.3 million has been confirmed from The National Institute of Health Research Health Technology Assessment programme for the study to be carried out over six years. Dr Patel said: “I am very pleased both for King’s Hepatology and for our ‘BOPPP Team’, which includes clinical colleague Dr Mark McPhail, with whom I work very closely and am co-Chief Investigator with, as well as our clinical colleagues within the Institute of Liver Studies and the wider team at the King’s Clinical Trials Unit that have all worked incredibly hard and supported us to secure the funding; notably Dr Ben Carter, Lead Statistician at King’s College London.
“This is a huge opportunity for a potentially landmark study, and if effective could benefit the lives for thousands 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 is also excited about the funding and the improved care it could bring to patients at King’s College Hospital, and potentially to the wider patient population afterwards. He said: “We predict a reduction in liver bleeding by almost 50% after three years of follow up with fewer hospital admissions.”
This is the first multi-centre trial Dr Patel has lead as Chief Investigator, having begun by setting up non-commercial investigator-initiated observational studies and interventional trials, including CTIMPs. He is also CI on the ongoing 'Gut-Liver Axis study in Chronic Liver Failure Syndromes’, which to date has recruited over 400 patient participants and 70 healthy volunteers. He says the Greenshoots funding has helped him: “I am one of the Greenshoots scheme recipients and this has facilitated my ability to recruit patients into recognised NIHR portfolio studies and, through supporting this activity in my job plan, has enabled me to free up other time to lead on this successful application - I am therefore grateful for the support from the CRN South London, as well as the wider BOPPP team who have all contributed to securing this substantial grant. I would recommend the Greenshoots scheme given the potential resource and encouragement it enables with time to focus on research related work-streams.”
Clinical Director of the CRN South London Professor Andrew Shennan created the Greenshoots programme and is delighted with this outcome. He said: “I want to congratulate Vishal on being funded for this important UK-wide study that has the potential to really improve the lives of those who suffer from chronic liver disease. It is encouraging that Vishal has leveraged the Greenshoots funding to put together this winning bid working closely with his colleagues at King’s College Hospital and the King’s Clinical Trials Unit. I wish the team on the BOPPP trial every success with this important research.”
