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
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 spontane...
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BMJ Publishing Group
2021-06-01
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| author | Chris Rogers Lucy Culliford Natalie S Blencowe Jane Blazeby William Hollingworth Kerry Avery Marcus Jepson Joanna Thorn Raneem Albazaz Barnaby Reeves Madeleine Clout Ravi Vohra Samir Pathak Ian Beckingham Ashley Guthrie Ewen A Griffiths Giles Toogood Michelle Lazaroo Neil Jennings Jane Collingwood Elizabeth Booth |
| author_facet | Chris Rogers Lucy Culliford Natalie S Blencowe Jane Blazeby William Hollingworth Kerry Avery Marcus Jepson Joanna Thorn Raneem Albazaz Barnaby Reeves Madeleine Clout Ravi Vohra Samir Pathak Ian Beckingham Ashley Guthrie Ewen A Griffiths Giles Toogood Michelle Lazaroo Neil Jennings Jane Collingwood Elizabeth Booth |
| author_sort | Chris Rogers |
| collection | DOAJ |
| description | 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.Trial registration number ISRCTN10378861. |
| format | Article |
| id | doaj-art-6fefdf4dc4534fb8907d2866b71db0a5 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-06-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-6fefdf4dc4534fb8907d2866b71db0a52024-11-18T22:35:12ZengBMJ Publishing GroupBMJ Open2044-60552021-06-0111610.1136/bmjopen-2020-044281Randomised 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 protocolChris Rogers0Lucy Culliford1Natalie S Blencowe2Jane Blazeby3William Hollingworth4Kerry Avery5Marcus Jepson6Joanna Thorn7Raneem Albazaz8Barnaby Reeves9Madeleine Clout10Ravi Vohra11Samir Pathak12Ian Beckingham13Ashley Guthrie14Ewen A Griffiths15Giles Toogood16Michelle Lazaroo17Neil Jennings18Jane Collingwood19Elizabeth Booth20Bristol Trials Centre, Clincal Trials and Evaulation Unit, Bristol Medical School, University of Bristol, Bristol, UK1 Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK5 Division of Surgery, Bristol Royal Infirmary, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UKPopulation Health Sciences, Bristol Medical School, University of Bristol, Bristol, UKPopulation Health Sciences, University of Bristol Medical School, Bristol, UK1National Institute for Health Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UKPopulation Health Sciences, University of Bristol, Bristol, UKBristol Population Health Science Institute, University of Bristol, Bristol, UKDepartment of Radiology, Leeds Teaching Hospitals NHS Trust, Leeds, UKClinical Trials and Evaluation Unit, University of Bristol Faculty of Medical and Veterinary Sciences, Bristol, UK1 Population Health Sciences, University of Bristol, Bristol, UKTrent Oesophago-Gastric Unit, Nottingham City Hospital, Nottingham, UKCentre for Surgical Research, Population Health Sciences, University of Bristol, Bristol, UKDivision of Gastrointestinal Surgery, Nottingham University Hospitals NHS Trust, Nottingham, UKClinical Radiology, Leeds Teaching Hospitals NHS Trust, Leeds, UKDepartment of Upper GI Surgery, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UKDepartment of Hepatobiliary and Transplantation Surgery, Leeds Teaching Hospitals NHS Trust, Leeds, UKBristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UKBariatric Unit, Department of Surgery, Sunderland Royal Hospital, Sunderland, UKSchool of Population Health Sciences, University of Bristol, Bristol, UKNHS Coventry and Rugby Clinical Commissioning Group, Coventry, UKIntroduction 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.Trial registration number ISRCTN10378861.https://bmjopen.bmj.com/content/11/6/e044281.full |
| spellingShingle | Chris Rogers Lucy Culliford Natalie S Blencowe Jane Blazeby William Hollingworth Kerry Avery Marcus Jepson Joanna Thorn Raneem Albazaz Barnaby Reeves Madeleine Clout Ravi Vohra Samir Pathak Ian Beckingham Ashley Guthrie Ewen A Griffiths Giles Toogood Michelle Lazaroo Neil Jennings Jane Collingwood Elizabeth Booth 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/11/6/e044281.full |
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