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: The Sunflower Study
Funder: NIHR HTA, Ref 16/142/04
REC Number: 18/YH/0358
Sponsor: Leeds Teaching Hospitals NHS Trust
Surgery to remove the gallbladder is required if it contains gallstones that cause problems. About 70,000 operations are performed annually in England. Sometimes, gallstones cause other problems if they pass from the gallbladder into the nearby bile duct. Then it is necessary to remove the bile duct stones before or during the gallbladder operation. Because of this, patients requiring gallbladder surgery are assessed for risk of bile duct stones. If the risk is high, further tests are done to identify if bile duct stones are present. If the risk is moderate or low, then it is uncertain whether further tests to look for bile duct stones are necessary. As a result, some surgeons choose to perform tests and others don’t.
The Sunflower Study will find out whether testing for bile duct stones before gallbladder surgery is worthwhile or not in patients with a low or moderate risk of having stones. Patients who consent to participate will be divided into two groups. One group will go straight to surgery (i.e. no additional test) and the other will be tested before surgery. The ‘straight to surgery’ group will have twice as many people in as the ‘tested’ group to reduce the number of extra tests performed. Both groups will be followed up for 18 months and information about the need for treatment of bile duct stones, complications of surgery and costs collected.
You can follow all the latest study news and updates on Twitter: @SunflowerStudy
Chief Investigator: Professor Giles Toogood
Study Manager: Maddie Clout