BMJ 2014;349:g6241 doi: 10.1136/bmj.g6241 (Published 30 October 2014)

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Practice

PRACTICE GUIDELINE

Diagnosis and management of gallstone disease: summary of NICE guidance Sheryl Warttig technical analyst, Steven Ward technical analyst (health economics), Gabriel Rogers technical adviser (health economics), On behalf of the Guideline Development Group National Institute for Health and Care Excellence, Manchester M1 4BT, UK

This is one of a series of BMJ summaries of new guidelines based on the best available evidence; they highlight important recommendations for clinical practice, especially where uncertainty or controversy exists.

Gallstone disease is common—10-15% of adults in Western populations are thought to have the condition.1 2 Concerns about inappropriate variation in the management of gallstones have led to the development of recommendations on the diagnosis and management of cholelithiasis, cholecystitis, and choledocholithiasis in an attempt to improve patient outcomes and promote effective use of resources. This article summarises the most recent recommendations on the management of gallstone disease from the National Institute for Health and Care Excellence (NICE).3

Recommendations

NICE recommendations are based on systematic reviews of best available evidence and explicit consideration of cost effectiveness. When minimal evidence is available, recommendations are based on the Guideline Development Group’s experience and opinion of what constitutes good practice. Evidence levels for the recommendations are given in italic in square brackets.

Diagnosis • Offer liver function tests and ultrasound to people with suspected gallstone disease and to people with abdominal or gastrointestinal symptoms that have not responded to previous management. [Based on moderate to very low quality observational studies] • Consider magnetic resonance cholangiopancreatography if ultrasound has not detected common bile duct stones but the: -Bile duct is dilated or -Liver function test results are abnormal (or both). • [Based on moderate to very low quality observational studies]

• Consider endoscopic ultrasound if magnetic resonance cholangiopancreatography does not allow a diagnosis to be made. [Based on moderate to very low quality observational studies]

Treating asymptomatic gallbladder stones • Reassure people with asymptomatic gallbladder stones found in a normal gallbladder and normal biliary tree that they do not need treatment unless they develop symptoms. [Based on the experience and opinion of the Guideline Development Group (GDG)]

Treating symptomatic gallbladder stones and symptomatic or asymptomatic common bile duct stones • Offer laparoscopic cholecystectomy to people diagnosed with symptomatic gallbladder stones. [Based on moderate to low quality randomised controlled trials and an original health economic model] • Offer bile duct clearance and laparoscopic cholecystectomy to people with symptomatic or asymptomatic common bile duct stones. [Based on moderate quality randomised controlled trials and an original health economic model] • Offer day case laparoscopic cholecystectomy to people who are having this operation as an elective planned procedure unless their circumstances or clinical condition make an inpatient stay necessary. [Based on moderate to low quality randomised controlled trials and an original health economic model] • Offer early laparoscopic cholecystectomy (to be carried out within one week of diagnosis) to people with acute cholecystitis. [Based on moderate to low quality randomised controlled trials and an original health economic model] • Clear the bile duct:

Correspondence to: S Warttig [email protected] For personal use only: See rights and reprints http://www.bmj.com/permissions

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BMJ 2014;349:g6241 doi: 10.1136/bmj.g6241 (Published 30 October 2014)

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PRACTICE

-Surgically at the time of laparoscopic cholecystectomy or -With endoscopic retrograde cholangiopancreatography before or at the time of laparoscopic cholecystectomy. • [Based on very low quality randomised controlled trial evidence and an original health economic model]

People with gallstone disease in whom surgery or ductal clearance is inappropriate • Reconsider laparoscopic cholecystectomy for people who have had percutaneous cholecystostomy once they are well enough for surgery, regardless of age and comorbidities. [Based on the experience and opinion of the GDG] • If the bile duct cannot be cleared with endoscopic retrograde cholangiopancreatography, use biliary stenting to achieve biliary drainage as a temporary measure only until definitive endoscopic or surgical clearance. [Based on the experience and opinion of the GDG]

Eating and drinking after cholecystectomy • Advise people that they should not need to avoid the food and drink that triggered their symptoms after they have their gallbladder or gallstones removed. [Based on the experience and opinion of the GDG] • Advise people to seek further advice from their GP if eating or drinking triggers existing symptoms or causes new symptoms to develop after they have recovered from having their gallbladder or gallstones removed, because they may have another underlying condition that needs investigation. [Based on the experience and opinion of the GDG]

Overcoming barriers Hospital services and those commissioning hospital services will need to review policies on the management of patients with gallstone disease. This may involve rearranging surgical lists

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so that laparoscopic cholecystectomy can be offered to patients with acute cholecystitis within one week of diagnosis, and scheduling radiological and surgical lists to enable endoscopic retrograde cholangiopancreatography to be delivered to patients with common bile duct stones at the time of laparoscopic cholecystectomy. The members of the Guideline Development Group were: Gary McVeigh (chair), Elaine Dobinson Evans, Simon Dwerryhouse, Rafik Filobbos, Imran Jawaid, Angela Madden (co-opted expert), Peter Morgan, Gerri Mortimore, Kofi Oppong, Charles Rendell, Richard Sturgess, Giles Toogood, and Luke Williams. The technical team at NICE included Gabriel Rogers, Steven Ward, and Sheryl Warttig. Contributors: SW wrote the first and subsequent drafts of this summary. All authors reviewed the drafts, were involved in writing further drafts, and reviewed and approved the final version for publication. SW is guarantor. Competing interests: We have read and understood BMJ policy on declaration of interests and declare the following interests: All authors are employees of the National Institute for Health and Care Excellence, which is commissioned and funded by the Department of Health to develop clinical guidelines. The authors’ full statements can be viewed at www.bmj.com/content/bmj/349/bmj.g6241/related#datasupp. Provenance and peer review: Commissioned; not externally peer reviewed. 1 2 3 4 5

Halldestam I, Enell EL, Kullman E, Borch K. Development of symptoms and complications in individuals with asymptomatic gallstones. Br J Surg 2004;91:734-8. NHS Choices. Cholecystitis, acute. 2014. www.nhs.uk/conditions/Cholecystitis-acute/ Pages/Introduction.aspx. National Institute for Health and Care Excellence. Gallstone disease. Diagnosis and management of cholelithiasis, cholecystitis and choledocholithiasis. (Clinical Guideline 188.) 2014. www.nice.org.uk/CG188. National Institute for Health and Care Excellence. The guidelines manual. 2012. www. nice.org.uk/article/PMG6/chapter/1%20Introduction. National Institute for Health and Care Excellence. Gallstones. Information for the public on NICE guideline CG188. 2014. www.nice.org.uk/guidance/cg188/informationforpublic.

Cite this as: BMJ 2014;349:g6241 © BMJ Publishing Group Ltd 2014

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BMJ 2014;349:g6241 doi: 10.1136/bmj.g6241 (Published 30 October 2014)

Page 3 of 2

PRACTICE

Further information on the guidance Methods The Guideline Development Group (GDG) followed standard National Institute for Health and Care Excellence (NICE) methods in the development of this guideline.4 The GDG included a consultant upper gastrointestinal surgeon, a consultant hepatobiliary and liver transplant surgeon, two consultant gastroenterologists, a hepatobiliary clinical nurse, two consultant gastrointestinal radiologists, an anaesthetist, a general practitioner, and two patient or lay members. The group also co-opted a dietitian. The GDG developed the review questions. To answer these questions, the NICE systematic reviewing team identified and analysed the clinical and health economic evidence. Meta-analysis, network meta-analysis, narrative analysis, and health economic modelling were undertaken whenever appropriate. GRADE methodology was also applied to develop quality ratings for the body of evidence. The GDG appraised and interpreted the evidence to develop the recommendations and research recommendations. A draft guideline, which went through a quality assurance process, was developed. The draft guideline was consulted on by a range of stakeholders who were invited to comment, and all comments were considered by the GDG when producing the final version of the guideline. Further updates of the guideline will be produced as part of NICE’s guideline development programme. NICE has produced four different versions of the guidance: a full version; a summary version known as the “NICE guidance;” a pathway; and a version for people using NHS services, their families and carers, and the public.5 All these versions, together with a suite of tools to help with implementation of the guidance, are available from the NICE website.3 Further updates of the guidance will be produced as part of NICE’s guideline development programme.

Future research The GDG identified the following areas for future research: What are the long term benefits and harms and cost effectiveness of endoscopic ultrasound (EUS) compared with magnetic resonance cholangiopancreatography (MRCP) in adults with suspected common bile duct stones? What are the benefits and harms, and cost effectiveness of routine intraoperative cholangiography in people with low to intermediate risk of common bile duct stones? What models of service delivery enable intraoperative endoscopic retrograde cholangiopancreatography (ERCP) for bile duct clearance to be delivered within the NHS? What are the costs and benefits of different models of service delivery? In adults with common bile duct stones, should laparoscopic cholecystectomy be performed early (within two weeks of bile duct clearance), or should it be delayed (until six weeks after bile duct clearance)? What is the long term effect of laparoscopic cholecystectomy on outcomes that are important to patients?

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Diagnosis and management of gallstone disease: summary of NICE guidance.

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