Greater Manchester EUR Policy Statement on: Asymptomatic Gallstones GM Ref: GM061 Version: 0.2 (21 November 2018)

Greater Manchester EUR Policy Statement on: Asymptomatic Gallstones GM Ref: GM061 Version: 0.2 (21 November 2018)

Commissioning Statement Asymptomatic Gallstones Policy Exclusions (Alternative commissioning arrangements apply) Fitness for Surgery Policy Inclusion Criteria Common bile duct (CBD) stones may present with symptoms of jaundice, cholangitis or pancreatitis, or be asymptomatic. All CBD stones should be referred for treatment because of the risk of potential severe complications. Treatment/procedures undertaken as part of an externally funded trial or as a part of locally agreed contracts / or pathways of care are excluded from this policy, i.e. locally agreed pathways take precedent over this policy (the EUR Team should be informed of any local pathway for this exclusion to take effect). NOTE: All patients should be assessed as fit for surgery before going ahead with treatment, even though funding has been approved. Surgical interventions for asymptomatic gallstones (except for those in the common bile duct) are not commissioned. Clinicians are expected to diagnose, refer and manage patients in line with NICE CG188: Gallstone disease: diagnosis and management (see Appendix 1 for a summary). Funding Mechanism Clinicians can submit an individual funding request outside of this guidance if they feel there is a good case for clinical exceptionality. Requests must be submitted with all relevant supporting evidence. Clinical Exceptionality Clinicians can submit an Individual Funding Request (IFR) outside of this guidance if they feel there is a good case for exceptionality. Exceptionality means a person to which the general rule is not applicable. Greater Manchester sets out the following guidance in terms of determining exceptionality; however the over-riding question which the IFR process must answer is whether each patient applying for exceptional funding has demonstrated that his/her circumstances are exceptional. A patient may be able to demonstrate exceptionality by showing that s/he is: Significantly different to the general population of patients with the condition in question. and as a result of that difference They are likely to gain significantly more benefit from the intervention than might be expected from the average patient with the condition. GM Gallstones Policy v0.2 DRAFT Page 2 of 13

Contents Commissioning Statement... 2 Policy Statement... 4 Equality & Equity Statement... 4 Governance Arrangements... 4 Aims and Objectives... 4 Rationale behind the policy statement... 5 Treatment / Procedure... 5 Epidemiology and Need... 5 Adherence to NICE Guidance... 5 Audit Requirements... 5 Date of Review... 5 Glossary... 6 References... 6 Governance Approvals... 6 Appendix 1 Evidence Review... 8 Appendix 2 Diagnostic and Procedure Codes... 12 Appendix 3 Version History... 13 GM Gallstones Policy v0.2 DRAFT Page 3 of 13

Policy Statement Greater Manchester Health and Care Commissioning (GMHCC) Effective Use of Resources (EUR) Policy Team, in conjunction with the GM EUR Steering Group, have developed this policy on behalf of Clinical Commissioning Groups (CCGs) within Greater Manchester, who will commission treatments/procedures in accordance with the criteria outlined in this document. In creating this policy GMHCC/GM EUR Steering Group reviewed asymptomatic gallstones and the options for its treatment. It has considered the place of this treatment in current clinical practice, whether scientific research has shown the treatment to be of benefit to patients, (including how any benefit is balanced against possible risks) and whether its use represents the best use of NHS resources. This policy document outlines the arrangements for funding of treatment for asymptomatic gallstones the population of Greater Manchester. This policy follows the principles set out in the ethical framework that govern the commissioning of NHS healthcare and those policies dealing with the approach to experimental treatments and processes for the management of individual funding requests (IFR). Equality & Equity Statement GMHCC/CCGs have a duty to have regard to the need to reduce health inequalities in access to health services and health outcomes achieved, as enshrined in the Health and Social Care Act 2012. GMHCC/CCGs are committed to ensuring equality of access and non-discrimination, irrespective of age, gender, disability (including learning disability), gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, gender or sexual orientation. In carrying out its functions, GMHCC/CCGs will have due regard to the different needs of protected characteristic groups, in line with the Equality Act 2010. This document is compliant with the NHS Constitution and the Human Rights Act 1998. This applies to all activities for which they are responsible, including policy development, review and implementation. In developing policy the GMHCC EUR Policy Team will ensure that equity is considered as well as equality. Equity means providing greater resource for those groups of the population with greater needs without disadvantage to any vulnerable group. The Equality Act 2010 states that we must treat disabled people as more equal than any other protected characteristic group. This is because their starting point is considered to be further back than any other group. This will be reflected in GMHCC evidencing taking due regard for fair access to healthcare information, services and premises. An Equality Analysis has been carried out on the policy. For more information about the Equality Analysis, please contact policyfeedback.gmscu@nhs.net. Governance Arrangements Greater Manchester EUR policy statements will be ratified by the Greater Manchester Joint Commissioning Board (GMJCB) prior to formal ratification through CCG Governing Bodies. Further details of the governance arrangements can be found in the GM EUR Operational Policy. Aims and Objectives This policy document aims to ensure equity, consistency and clarity in the commissioning of treatments/procedures by CCGs in Greater Manchester by: reducing the variation in access to treatments/procedures. GM Gallstones Policy v0.2 DRAFT Page 4 of 13

ensuring that treatments/procedures are commissioned where there is acceptable evidence of clinical benefit and cost-effectiveness. reducing unacceptable variation in the commissioning of treatments/procedures across Greater Manchester. promoting the cost-effective use of healthcare resources. Rationale behind the policy statement Asymptomatic gallstones are very common. No treatment is required unless symptoms or signs develop such as abdominal pains, abdominal discomfort, or jaundice. Any treatment aimed at preventing future complications is not recommended (such as prophylactic cholecystectomy) as the risk of complications from surgical treatment outweighs the potential risk of developing complications from the stones 4. Treatment / Procedure Gallstones are small stones, usually made of cholesterol, that form in the gallbladder. In most cases, they don't cause any symptoms and don't need to be treated. Surgery may remove the entire gallbladder (cholecystectomy), or just the stones from bile ducts. Techniques to remove the gallbladder include: laparoscopic cholecystectomy 'keyhole' surgery. The surgeon makes small incisions (cuts) through the skin, allowing access for a range of instruments, the surgeon then removes the gallbladder through one of the incisions. Open surgery (laparotomy) the surgeon reaches the gallbladder through a wider abdominal incision. Epidemiology and Need In the UK around 10-15% of the adult population have gallstones 3. The majority of people with gallbladder stones remain asymptomatic and require no treatment. The definitive treatment of symptomatic gallbladder stones is surgical removal of the gallbladder. Adherence to NICE Guidance This policy adheres to NICE CG188: Gallstone disease: diagnosis and management. Audit Requirements There is currently no national database. Service providers will be expected to collect and provide audit data on request. Date of Review One year from the date of approval by the governance process and thereafter at a date agreed by the Greater Manchester EUR Steering Group, unless new evidence or technology is available sooner. The evidence base for the policy will be reviewed and any recommendations within the policy will be checked against any new evidence. Any operational issues will also be considered at this time. All available additional data on outcomes will be included in the review and the policy updated accordingly. The policy will be continued, amended or withdrawn subject to the outcome of that review. GM Gallstones Policy v0.2 DRAFT Page 5 of 13

Glossary Term Asymptomatic gallstones Cholelithiasis Common bile duct Meaning the presence of gallstones detected incidentally in patients who do not have any abdominal symptoms or have symptoms that are not thought to be due to gallstones. Diagnosis is made during routine ultrasound for other abdominal conditions or, occasionally, by palpation of the gall bladder at operation. This definition implies that we know which symptoms are specific to gallstones. Gallstones The common bile duct is a small, tube-like structure formed where the common hepatic duct and the cystic duct join. Its physiological role is to carry bile from the gallbladder and empty it into the upper part of the small intestine (the duodenum). Cystic duct Hepatic Laparoscopic cholecystectomy Laparotomy The cystic duct transfers bile between the gallbladder and common and hepatic bile ducts. Pertaining to the liver. The surgeon makes small incisions (cuts) through the skin, allowing access for a range of instruments to remove the gall bladder. A surgical incision into the abdominal cavity, for diagnosis or in preparation for major surgery. References 1. Greater Manchester Effective Use of Resources Operational Policy 2. World Gastroenterology Organisation Practice Guideline: Asymptomatic Gallstone Disease 3. Royal College of Surgeons Commissioning guide 2013 Gallstone Disease 4. NICE Clinical Knowledge Summary- Asymptomatic Gallstones Governance Approvals Name Date Approved Greater Manchester Effective Use of Resources Steering Group Greater Manchester Chief Finance Officers / Greater Manchester Directors of Commissioning GM Gallstones Policy v0.2 DRAFT Page 6 of 13

Greater Manchester Joint Commissioning Board Bury Clinical Commissioning Group Bolton Clinical Commissioning Group Heywood, Middleton & Rochdale Clinical Commissioning Group Manchester Clinical Commissioning Group Oldham Clinical Commissioning Group Salford Clinical Commissioning Group Stockport Clinical Commissioning Group Tameside & Glossop Clinical Commissioning Group Trafford Clinical Commissioning Group Wigan Borough Clinical Commissioning Group GM Gallstones Policy v0.2 DRAFT Page 7 of 13

Appendix 1 Evidence Review Asymptomatic Gallstones GM061 Search Strategy The following databases are routinely searched: NICE Clinical Guidance and full website search; NHS Evidence and NICE CKS; SIGN; Cochrane; York; and the relevant Royal College and any other relevant bespoke sites. A Medline / Open Athens search is undertaken where indicated and a general google search for key terms may also be undertaken. The results from these and any other sources are included in the table below. If nothing is found on a particular website it will not appear in the table below: Database Result NICE evidence NICE CKS: Gallstones, Last revised: February 2015 NICE guidance NICE CG188: Gallstone disease: diagnosis and management, Published: 29 October 2014 NICE Quality Standard (QS104): Gallstone disease NICE Quality standard, Published: 3 December 2015 (not cited here) RCS website RCS Commissioning Guide 2013: Gallstone disease Summary of the evidence The evidence-based consensus in all of the above guidelines is that the risks of surgery are not outweighed by the benefits for the removal of asymptomatic gallstones with the exception of those found in the common bile duct and, as such, it should not be considered in the majority of cases. The evidence Levels of evidence Level 1 Level 2 Level 3 Level 4 Level 5 Meta-analyses, systematic reviews of randomised controlled trials Randomised controlled trials Case-control or cohort studies Non-analytic studies e.g. case reports, case series Expert opinion 1. LEVEL 1: NICE CLINICAL GUIDELINES NICE CG188: Gallstone disease: diagnosis and management, Published: 29 October 2014 1 Recommendations 1.1 Diagnosing gallstone disease 1.1.1 Offer liver function tests and ultrasound to people with suspected gallstone disease, and to people with abdominal or gastrointestinal symptoms that have been unresponsive to previous management. 1.1.2 Consider magnetic resonance cholangiopancreatography (MRCP) if ultrasound has not detected common bile duct stones but the: bile duct is dilated and/or GM Gallstones Policy v0.2 DRAFT Page 8 of 13

liver function test results are abnormal. 1.1.3 Consider endoscopic ultrasound (EUS) if MRCP does not allow a diagnosis to be made. 1.1.4 Refer people for further investigations if conditions other than gallstone disease are suspected. 1.2 Managing gallbladder stones 1.2.1 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. 1.2.2 Offer laparoscopic cholecystectomy to people diagnosed with symptomatic gallbladder stones. 1.2.3 Offer day-case laparoscopic cholecystectomy for people having it as an elective planned procedure, unless their circumstances or clinical condition make an inpatient stay necessary. 1.2.4 Offer early laparoscopic cholecystectomy (to be carried out within 1 week of diagnosis) to people with acute cholecystitis. 1.2.5 Offer percutaneous cholecystostomy to manage gallbladder empyema when: surgery is contraindicated at presentation and conservative management is unsuccessful. 1.2.6 Reconsider laparoscopic cholecystectomy for people who have had percutaneous cholecystostomy once they are well enough for surgery. 1.3 Managing common bile duct stones 1.3.1 Offer bile duct clearance and laparoscopic cholecystectomy to people with symptomatic or asymptomatic common bile duct stones. 1.3.2 Clear the bile duct: surgically at the time of laparoscopic cholecystectomy or with endoscopic retrograde cholangiopancreatography (ERCP) before or at the time of laparoscopic cholecystectomy. 1.3.3 If the bile duct cannot be cleared with ERCP, use biliary stenting to achieve biliary drainage only as a temporary measure until definitive endoscopic or surgical clearance. 1.3.4 Use the lowest-cost option suitable for the clinical situation when choosing between day-case and inpatient procedures for elective ERCP. Patient, family member and carer information 1.4.1 Advise people to avoid food and drink that triggers their symptoms until they have their gallbladder or gallstones removed. 1.4.2 Advise people that they should not need to avoid food and drink that triggered their symptoms after they have their gallbladder or gallstones removed. 1.4.3 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. 2. LEVEL 1: RCS COMMISSIONING GUIDE RCS Commissioning Guide 2013: Gallstone disease 1 High value care pathway for gallstone disease 1.1 Primary care Non-referral Patients with an incidental finding of stones in an otherwise normal gallbladder require no further investigation or referral. Primary care management Most patients with symptomatic gallstones present with a self-limiting attack of pain that lasts for hours only. This can often be controlled successfully in primary care with appropriate analgesia, avoiding the requirement for emergency admission. When pain cannot be managed or if the patient is otherwise unwell (e.g. sepsis), he or she should be referred to hospital as an emergency. GM Gallstones Policy v0.2 DRAFT Page 9 of 13

Further episodes of biliary pain can be prevented in around 30% of patients by adopting a low fat diet. Fat in the stomach releases cholecystokinin, which precipitates gallbladder contraction and might result in biliary pain. Patients with suspicion of acute cholecystitis, cholangitis or acute pancreatitis should be referred to hospital as an emergency. There is no evidence to support the use of hyoscine or proton pump inhibitors in the management of gallbladder symptoms. Antibiotics should be reserved for patients with signs of sepsis. There is no evidence of benefit from the use of non-surgical treatments in the definitive management of gallbladder stones (e.g. gallstone dissolution therapies, ursodeoxycholic acid or extracorporeal lithotripsy). Best practice referral guidelines Epigastric or right upper quadrant pain, frequently radiating to the back, lasting for several minutes to hours (often occurring at night) suggests symptomatic gallstones. These patients should have liver function tests checked and be referred for ultrasonography. Confirmation of symptomatic gallstones should result in a discussion of the merits of a referral to a surgical service regularly performing cholecystectomies. Following treatment for CBD stones with endoscopic retrograde cholangiopancreatography (ERCP) and sphincterotomy, removal of the gallbladder should be considered in all patients. However, in patients with significant co-morbidities, the risks of surgery may outweigh the benefits. Patients with known gallstones with a history of acute pancreatitis should be referred for a cholecystectomy to a surgical service regularly performing the procedure. Patients with known gallstones and jaundice or clinical suspicion of biliary obstruction (e.g. significantly abnormal liver function tests) should be referred urgently to a gastroenterology or surgical service with expertise in managing biliary diseases. 1.2 Secondary care In patients with symptomatic gallstones, the decision to operate is made by the patient with guidance from the surgeon. This will include assessment of the risk of recurrent symptoms and complications of the gallstones (50% risk per annum of further episode of biliary colic and 1 2% risk per annum of development of serious complications), and the risks and complication rates of surgery in relation to the individual patient s co-morbidities and preference. Patients with acute gallstone pancreatitis should undergo definitive treatment (usually cholecystectomy although an endoscopic sphincterotomy may be appropriate in frail patients) within two weeks of recovery from the incident episode, as described in the UK guidelines for the management of acute pancreatitis. If the cause of abnormal liver function tests +/- dilated bile ducts is unclear on initial imaging, further investigation is required. This will usually be with preoperative magnetic resonance cholangiopancreatography or endoscopic ultrasonography. ERCP should be reserved for therapy, not as a diagnostic test for bile duct stones. Preoperative on-table cholangiography is an alternative strategy in units that offer laparoscopic bile duct exploration. Patients with symptomatic CBD stones should undergo CBD stone extraction by ERCP or surgical bile duct exploration (laparoscopic or open). Patients with asymptomatic gallstones should also be considered for stone extraction. The laparoscopic approach to cholecystectomy should be considered the standard for the majority of patients. Secondary providers offering cholecystectomy must be able to offer intraoperative on-table cholangiography and have arrangements in place for urgent access to ERCP and interventional radiology for the management of postoperative complications. Patients who have a suspected bile duct injury should be referred to their regional tertiary hepatopancreatobiliary service. GM Gallstones Policy v0.2 DRAFT Page 10 of 13

3. LEVEL N/A: NICE CLINICAL KNOWLEDGE SUMMARY NICE CKS: Gallstones, Last revised: February 2015 Scenario: Asymptomatic gallstones Scenario: Management of people with asymptomatic gallstones Age from 18 years onwards How do I manage a person with asymptomatic gallstones? For a person with asymptomatic gallstones found in a normal gallbladder, and with a normal biliary tree, explain to the person that: o Asymptomatic gallstones are very common. o No treatment is required unless symptoms or signs develop such as abdominal pains, abdominal discomfort, or jaundice, when they should seek medical advice. o Any treatment aimed at preventing future complications is also not recommended (such as prophylactic cholecystectomy) as the risk of complications from surgical treatment outweighs the potential risk of developing complications from the stones. For a person with asymptomatic gallstones found in the common bile duct, explain to the person that: o Although they are asymptomatic, there is a significant risk of developing serious complications such as cholangitis or pancreatitis. o Therefore, they should be managed the same as a person with Symptomatic gallstones with common bile duct stones. Basis for recommendation No treatment for asymptomatic gallstones in a normal gallbladder with a normal biliary tree The recommendation that treatment is not required is based on the National Institute for Health and Care Excellence (NICE) guideline Gallstone disease: Diagnosis and management of cholelithiasis, cholecystitis and choledocholithiasis[nice, 2014]. This is consistent with the Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland Commissioning guide: gallstone disease which states that 'patients with an incidental finding of stones in an otherwise normal gallbladder require no further investigation or referral' [Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland, 2013]. Treatment for asymptomatic gallstones found in the common bile duct The recommendation that treatment is required is based on the NICE guideline Gallstone disease: Diagnosis and management of cholelithiasis, cholecystitis and choledocholithiasis [NICE, 2014]. This is consistent with the Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland Commissioning guide: gallstone disease which states that 'all common bile duct stones should be referred for treatment because of the risk of potential severe complications' [Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland, 2013]. GM Gallstones Policy v0.2 DRAFT Page 11 of 13

Appendix 2 Diagnostic and Procedure Codes Asymptomatic Gallstones GM061 (All codes have been verified by Mersey Internal Audit s Clinical Coding Academy) [To add when final policy approved] GM Gallstones Policy v0.2 DRAFT Page 12 of 13

Appendix 3 Version History Asymptomatic Gallstones GM061 The latest version of this policy can be found here [To add link when final policy approved] Version Date Summary of Changes 0.1 08/11/2018 Initial draft 0.2 21/11/2018 Policy approved at GM EUR Steering Group to progress to Clinical Engagement with no amendments needing to be made. GM Gallstones Policy v0.2 DRAFT Page 13 of 13