A new study into the treatment of gallbladder stones - conditions which lead to around 80,000 operations a year in the UK - is being directed by Professor Irfan Ahmed of NHS Grampian and Professor Craig Ramsay of the University of Aberdeen.
Joint Chief Investigators, Prof. Ramsay and Prof. Ahmed have been awarded £1.4 million from the National Institute for Health Research Health Technology Assessment Programme fundsto investigate whether pain relief may be as effective for patients with symptomatic gallstones, rather than surgery to remove them.
About 10-15% of the adult UK population have gallstones and more women (22%) than men (12%) have them. Around 1 in 3 people with gallstones can develop symptoms, usually a severe pain, called ‘biliary colic’, in the upper right side of the stomach. The standard treatment for gallbladder symptoms due to gallstones is surgery to remove the gallbladder, and this is one of the most common procedures in the UK and costs between £2,500 and £5,000 per procedure. Around 70,000 procedures are carried out in the UK per year. This new study will look at the effectiveness of a non-invasive method for patients.
“In people with symptomatic gallstone disease, the rates of developing minor/major surgical complications can be as high as 10-15%. Even though removal of the gallbladder is considered the standard treatment for symptomatic gallstones, it does not guarantee eradication of symptoms, as one third of the patients may continue to experience pain and abdominal symptoms after surgery. So we want to investigate, through a robustly conducted randomised controlled trial, whether a non-surgical approach would be better for some patients,” said Prof. Ahmed, a Consultant Hepatobiliary Surgeon at Aberdeen Royal Infirmary.
“Reducing the number of non-essential operations would be good news for patients and could make a significant impact on the demands on our hospitals and staff, as there are costs related to surgery and to treatment of post-surgery complications.”
The project builds on a study published in 2014** which showed that as there was a lack of robust evidence in the UK setting about comparing the surgery and ‘wait and see’ options.
Prof. Ramsay, of the University’s Health Services Research Unit said: “Evidence also shows that up to 50% of people whose symptoms are managed conservatively with analgesia and dietary advice never experience a recurrence of pain episodes. This means some 30,000 cholecystectomies per year could be avoided with a potential saving for the NHS of £68 million annually.
“The aim of our multi-centre randomised trial is to compare outcomes of laparoscopic cholecystectomy – gallbladder removal – with advice, over-the-counter medications and general practice management, over an 18 month follow-up period.
“Our findings could have far-reaching consequences for policy-makers across the industrialised world, as this condition is common throughout.”
Aberdeen Royal Infirmary will be leading the trial and subsequently 20 centres from across UK will be recruiting the patients in the study after the initial pilot.
At these centres, adult patients with symptomatic uncomplicated gallstone disease who are referred for consideration of cholecystectomy will be randomised to laparoscopic cholecystectomy or conservative (‘watch and wait’) management. It is anticipated around 430 patients will be recruited in the study. Data will be collected from hospital and medical notes and patient questionnaires.
The study not only has great potential for the current demand for gallstone operations, but for future pressure on the NHS, says Prof. Ahmed: “The number of people being diagnosed with gallbladder problems has increased over years. With even more people likely to be considered for operations according to the existing guidelines, this study is timely.”
Prof. Ramsay concluded: “We anticipate that the results of this trial will influence national and international guidelines and, ultimately, clinical practice.”