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

被引：10

作者：

Clout, Madeleine ^{[1
]}

Blazeby, Jane ^{[2
]}

Rogers, Chris ^{[1
]}

Reeves, Barnaby ^{[1
]}

Lazaroo, Michelle ^{[1
]}

Avery, Kerry ^{[2
]}

Blencowe, Natalie S. ^{[2
]}

Vohra, Ravi ^{[3
]}

Jennings, Neil ^{[4
]}

Hollingworth, William ^{[5
]}

Thorn, Joanna ^{[5
]}

Jepson, Marcus ^{[5
]}

Collingwood, Jane ^{[5
]}

Guthrie, Ashley ^{[6
]}

Booth, Elizabeth ^{[7
]}

Pathak, Samir ^{[8
]}

Beckingham, Ian ^{[9
]}

Culliford, Lucy ^{[1
]}

Griffiths, Ewen A. ^{[10
]}

Albazaz, Raneem ^{[6
]}

Toogood, Giles ^{[11
]}

机构：

[1] Univ Bristol, Clin Trials & Evaluat Unit, Fac Med & Vet Sci, Bristol, Avon, England

[2] Univ Bristol, Ctr Surg Res, Sch Social & Community Med, Bristol, Avon, England

[3] Nottingham City Hosp, Trent Oesophagogastr Unit, Nottingham, England

[4] Sunderland Royal Hosp, Dept Surg, Bariatr Unit, Sunderland, England

[5] Univ Bristol, Sch Populat Hlth Sci, Bristol, Avon, England

[6] Leeds Teaching Hosp NHS Trust, Clin Radiol, Leeds, W Yorkshire, England

[7] NHS Coventry & Rugby Clin Commissioning Grp, Coventry, W Midlands, England

[8] Univ Bristol, Populat Hlth Sci, Ctr Surg Res, Bristol, Avon, England

[9] Nottingham Univ Hosp NHS Trust, Div Gastrointestinal Surg, Nottingham, England

[10] Univ Hosp Birmingham NHS Fdn Trust, Dept Upper GI Surg, Birmingham, W Midlands, England

[11] Leeds Teaching Hosp NHS Trust, Dept Hepatobiliary & Transplantat Surg, Leeds, W Yorkshire, England

来源：

BMJ OPEN | 2021年 / 11卷 / 06期

基金：

美国国家卫生研究院;

关键词：

magnetic resonance imaging; endoscopy; surgery; gastroenterology; nephrology; clinical trials; ENDOSCOPY;

D O I：

10.1136/bmjopen-2020-044281

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页数：10