Randomised controlled trial to establish the clinical and cost-effectiveness of expectant management versus preoperative 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): a study protocol

Maddie J Clout*, Jane M Blazeby, Chris A Rogers, Barnaby C Reeves, Clinical Trials and Evaluation Unit (CTEU) Bristol Trials Centre Bristol Medical School University of Bristol UK, Kerry N L Avery, Natalie S Blencowe, Ravi Vohra, Neil Jenning, William Hollingworth, School of Health and Medicine Lancaster University Bailing Upper Market Street Lancaster Lancashire UK 4YW, Marcus J Jepson, Jane M Collingwood, Ashley Guthrie, Elizabeth Booth, Samir Pathak, Ian Beckingham, Lucy A Culliford, Ewen Griffiths, Raneem Albazaz Giles Toogood

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)peer-review

1 Citation (Scopus)
4 Downloads (Pure)

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 preoperatively 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 UK. The consequences of these decisions may lead to overtreatment or undertreatment 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 preoperative imaging with MRCP versus expectant management (ie, no preoperative 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, for example, National Health Service 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.
Original languageEnglish
Article numbere044281
Pages (from-to)e044281
Number of pages12
JournalBMJ Open
Volume11
Issue number6
DOIs
Publication statusPublished - 29 Jun 2021

Bibliographical note

Funding Information:
Funding This work is supported by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (Grant Ref: 16/142/04). The study is also supported by the Royal College of Surgeons Surgical Trials Centre in Bristol. JB, CR, BR and KA are all supported by the NIHR Bristol and Weston Biomedical Research Centre. JB is an NIHR senior investigator. The study sponsor is Leeds Teaching Hospitals NHS Trust (Research Governance Manager Anne Gowing, anne.gowing@nhs.net), and the study is managed by the Bristol Trials Centre, Clinical Trials and Evaluation Unit. This study was designed and is being delivered in collaboration with the Bristol Trials Centre, Clinical Trials and Evaluation Unit, a UK Clinical Research Collaboration registered clinical trials unit, which is in receipt of NIHR clinical trials unit support funding. The research team acknowledges the support of the NIHR Clinical Research Network. The Sunflower Study is overseen by an independent SSC and DMSC. The study has been designed with input from public and patient groups.

Funding Information:
Acknowledgements The authors would like to thank all study staff involved in recruitment, coordination and data collection for this study, and members of the patient and public involvement group who assisted with study design and review of study documents. Special thanks are also given to the clinical and nursing teams at participating centres for their support in the conduct of the study. The authors would like to acknowledge the data monitoring and safety committee (DMSC) and study steering committee (SSC) for their oversight of the study. The independent DMSC is formed of a chairperson, one consultant surgeon and one consultant radiologist. The SSC is formed of a chairperson, two consultant surgeons, two consultant radiologists, one medical statistician and two public and patient involvement representatives; other SSC members with observer status represent the study executive group (SEG) in these committees. The Sunflower SEG is made up of the following: Madeleine Clout, Jane Blazeby, Chris Rogers, Barnaby Reeves, Michelle Lazaroo, Kerry Avery, Natalie Blencowe, Ravi Vohra, Neil Jennings, William Hollingworth, Joanna Thorn, Marcus Jepson, Jane Collingwood, Ashley Guthrie, Elizabeth Booth, Samir Pathak, Ian Beckingham, Lucy Culliford, Ewen Griffiths, Raneem Albazaz and Giles Toogood. Patients and/or the public were involved in the design of this research. Patients and/or the public are/will be involved in the conduct, reporting and dissemination plans of this research. Refer to the Methods section for further details. The study is formally supported by the Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland and the Great Britain & Ireland Hepato Pancreato Biliary Association, both of which recognise the importance of the objectives of this study.

Publisher Copyright:
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.

Fingerprint

Dive into the research topics of 'Randomised controlled trial to establish the clinical and cost-effectiveness of expectant management versus preoperative 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): a study protocol'. Together they form a unique fingerprint.

Cite this