The Sunflower Study
Research type
Research Study
Full title
A randomised controlled trial to establish the clinical and cost effectiveness of expectant management versus pre-operative imaging with Magnetic Resonance Cholangiopancreatography (MRCP) in patients with symptomatic gallstones undergoing laparoscopic cholecystectomy at low or moderate risk of common bile duct stones
IRAS ID
242342
Contact name
Giles Toogood
Contact email
Sponsor organisation
Leeds Teaching Hospitals NHS Trust
Duration of Study in the UK
5 years, 11 months, 31 days
Research summary
Gallbladder removal surgery (laparoscopic cholecystectomy) is one of the most common operations undertaken in the Western World, with around 70,000 operations performed annually in England. Patients require gallbladder removal when gallbladder stones are found using an ultrasound scan. Occasionally (in an estimated 2-5 in every hundred or 2-5% of patients), gallbladder stones may move in to the common bile duct, where they may remain without symptoms, cause problems or move spontaneously in to the stomach. As such, when patients are checked for gallbladder stones, the common bile duct is also checked using an ultrasound scan. If patients are found to be at a high risk of common bile duct stones, it is standard practice for patients to have further investigation using a type of scan called a magnetic resonance cholangiopancreatogram (MRCP). If common bile duct stones are identified during the MRCP scan, the stones are usually removed using a telescope procedure called an endoscopic retrograde cholangio-pancreatography (ERCP). However, for patients at low/medium risk of common bile duct stones (around 80 in every hundred, or 80% of patients), it is unclear whether further investigation with an MRCP is beneficial – fewer than 10 in every hundred (less than 10%) of these patients will have common bile duct stones.
The Sunflower study will compare the proportion of patients at low/moderate risk of common bile duct stones experiencing a gallstone related complication following their gallbladder removal surgery, whether they had imaging of their common bile duct with MRCP before their operation or did not. 1 in 3 patients in the study will be assigned by chance to have the MRCP, and the other 2 in 3 patients be assigned by chance to not have the MRCP.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
18/YH/0358
Date of REC Opinion
12 Dec 2018
REC opinion
Further Information Favourable Opinion