Study protocol for a randomised controlled trial to establish the clinical and cost effectiveness of expectant management versus pre-operative imaging with magnetic resonance cholangiopancreatography in patients with symptomatic gallbladder disease undergoing laparoscopic cholecystectomy at low or moderate risk of common bile duct stones (The Sunflower Study)

Maddie J Clout, Jane M Blazeby, Chris A Rogers, Barnaby C Reeves, Michelle J Lazaroo, Kerry N L Avery, Natalie S Blencowe, Ravi Vohra, Neil Jenning, William Hollingworth, Joanna C Thorn, Marcus J Jepson, Jane M Collingwood, Ashley Guthrie, Elizabeth Booth, Samir Pathak, Ian Beckingham, Lucy A Culliford, Ewen Griffiths, Raneem Albazaz Giles Toogood

Research output: Contribution to journalArticle (Academic Journal)

Abstract

Introduction Surgery to remove the gallbladder (laparoscopic cholecystectomy (LC)) is the standard treatment for symptomatic gallbladder disease. One potential complication of gallbladder disease is that gallstones can pass into the common bile duct (CBD) where they may remain dormant, pass spontaneously into the bowel or cause problems such as obstructive jaundice or pancreatitis. Patients requiring LC are assessed pre-operatively for their risk of CBD stones using liver function tests and imaging. If the risk is high, guidelines recommend further investigation and treatment. Further investigation of patients at low or moderate risk of CBD stones is not standardised, and the practice of imaging the CBD using magnetic resonance cholangiopancreatography (MRCP) in these patients varies across the United Kingdom (UK). The consequences of these decisions may lead to over or under treatment of patients. Methods and analysis We are conducting a UK multicentre, pragmatic, open, randomised controlled trial with internal pilot phase to compare the effectiveness and cost-effectiveness of pre-operative imaging with MRCP versus expectant management (i.e. no pre-operative imaging) in adult patients with symptomatic gallbladder disease undergoing urgent or elective LC who are at low or moderate risk of CBD stones. We aim to recruit 13,680 patients over 48 months. The primary outcome is any hospital admission within 18 months of randomisation for a complication of gallstones. This includes complications of endoscopic retrograde cholangiopancreatography for the treatment of gallstones, and complications of LC. This will be determined using routine data sources, e.g. NHS Digital Hospital Episode Statistics for participants in England. Secondary outcomes include cost-effectiveness and patient-reported quality of life, with participants followed up for a median of 18 months. Ethics and dissemination This study received approval from Yorkshire & The Humber – South Yorkshire Research Ethics Committee. Results will be submitted for publication in a peer-reviewed journal. Registration details: ISRCTN10378861
Original languageEnglish
JournalBMJ Open
Publication statusAccepted/In press - 28 Mar 2021

Keywords

  • gallstones
  • gall bladder disease
  • laparoscopic cholecystectomy
  • magnetic resonance cholangiopancreatography
  • randomised controlled trial
  • common bile duct
  • endoscopic retrograde cholangiopancreatography

Cite this