Sunflower is a pragmatic multicentre randomised controlled trial to compare expectant management (i.e. no imaging) versus pre-operative imaging with MRCP in patients with symptomatic gallstones undergoing laparoscopic cholecystectomy at low or moderate risk of common bile duct stones. The measured endpoints are clinical and cost effectiveness.
The study is led by Professor Giles Toogood, from Leeds Teaching Hospitals, in conjunction with the Bristol Clinical Trials Unit. Funding is from the Health Technology Assessment Programme of the National Institute for Health Research.
Key Objectives
• To estimate the difference between groups (expectant management vs MRCP) in the proportion of participants requiring a hospital admission for treatment of a complication of gallstones in the gallbladder/CBD and related to laparoscopic cholecystectomy;
• To estimate the difference between groups with respect to a range of secondary outcomes, including symptoms related to complications of gallstones in the gallbladder/CBD and related to laparoscopic cholecystectomy;
• To estimate the cost-effectiveness of MRCP compared to expectant management.
Recruitment
The study aims to recruit 13,680 participants in total (with one third randomised to MRCP and two thirds straight to laparoscopic cholecystectomy) from at least 50 centres across the UK. Recruitment is due to start in 2018. For further details please contact:
SUNFLOWER Study Group
Research Floor Level 7
Queens Building
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
Tel: 0117 342 2987
Email: [email protected]
The Sunflower study is funded by the NIHR HTA Programme (project number 16/142/04). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR HTA or the Department of Health.
