Cholecystectomy for Gallstones Adherence to Evidence Based Medicine Programme Evidence Summary Pack (Version 2) Cholecystectomy for Gallstones Local commissioners working with local people for a healthier future

About the AEBM Programme Enfield Clinical Commissioning Group, along with our North Central London colleagues, wants to the secure the greatest health impact it can with its resources by adhering as closely as possible to the clinical evidence base available. There is considerable national and international evidence that many procedures offered routinely by the NHS are of limited clinical benefit to patients in some or all circumstances. Therefore there needs to be careful consideration as to whether or not a procedure is going to be of any benefit to an individual patient before deciding to undertake it. To do this we must use the best and most up to date clinical advice and evidence to ensure we have the best chance of delivering a benefit to each individual patient who is put forward for treatment. This  evidence published by the National Institute for Health & Care Excellence(NICE) as well as available evidence published by the Royal Colleges and other Clinical Commissioning Groups. This will also ensure the best value from the services we commission. To ensure this decision making process is applied consistently, Enfield Clinical Commissioning Group along with the other Clinical Commissioning Groups in North Central London, adopted a common policy concerning these procedures that have limited clinical effectiveness in 2012 based on the best available evidence at that time. As the clinical evidence base moves on we are now undertaking a further review to ensure that we are using the best and latest clinical evidence in our decision making. We are also looking at the range of procedures where the evidence base now suggests we need to make changes to the guidance for individual patient situations to avoid the risk of undertaking procedures that have little or no benefit to patients or even where the undertaking of the procedure could result in a risk of harm. Clinical Leaders at the Clinical Commissioning Group with the full support of the Governing Body are leading this review. Enfield Clinical Commissioning Group will engage widely and consult formally on the proposals which emerge, while continuing to work closely with partner Clinical Commissioning Groups in North Central London.

About the Evidence Pack This evidence pack summarises the evidence that the Clinicians working on the AEBM Programme have reviewed prior to the commencement of the consultation process. Due to the nature of many of the documents reviewed it is not possible to repeat the evidence in its entirety. The first version of these Evidence Packs only contained highlights of the information and clinical evidence reviewed and based on feedback from our public this was seen as an oversight and therefore a more comprehensive summary is now being provided. These packs will be made available along with the underpinning documents that were used. The purpose of the Consultation is to enable clinicians, patients, our public and other stakeholders to contribute to the debate including identifying additional evidence that may have been missed by the clinicians working on the programme during the pre-consultation phase. The views of all participants in the consultation along with any additional evidence that comes to light during the consultation programme will be taken through further clinical review at the end of the consultation programme. We would like to thank all who have contributed during the extensive pre-consultation phase (that lasted from September 16 through to March 17) and all who are now taking the time to contribute during the formal consultation phase.

About the Approach Taken In preparing these Evidence Packs we undertook an extensive review of available clinical data and evidence and looked in detail at the evidence used (or at least reviewed) by other Clinical Commissioning Groups during similar exercises. The span of this work included (but was not limited to) the following: NICE BMA Royal Colleges All London CCGs CCGs outside of London including Cambridge, Berkshire, North Staffordshire and many others Guidance documents available from relevant stakeholder websites We then collated the evidence including eligibility criteria that CCGs had reviewed (although it is noted not all may have gone on to implement the changes) and then added in local data such as activity and spend, trend analysis and benchmarking. This collated data and evidence was then reviewed by a wide range of clinicians including secondary care representatives before being summarised into these Evidence Packs for use during the consultation. The purpose of these Evidence Packs is to provide a summary of the extensive clinical review that was undertaken prior to the commencement of the Consultation Period but we recognise that further evidence might come to light during the consultation process and this is the reason for undertaking the consultation before any decisions are made to ensure we have used all of the available evidence in our final decision making processes.

Enfield CCG Evidence Summary (Page 1) NICE Guidance: Substantial information concerning Cholecystectomy for Gallstones exists on the NICE Website (Clinical Knowledge Summaries) and is summarised below. Diagnosing gallstone disease 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. Consider magnetic resonance cholangiopancreatography (MRCP) if ultrasound has not detected common bile duct stones but the: bile duct is dilated and/or liver function test results are abnormal. Consider endoscopic ultrasound (EUS) if MRCP does not allow a diagnosis to be made. Refer people for further investigations if conditions other than gallstone disease are suspected. Managing 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. Offer laparoscopic cholecystectomy to people diagnosed with symptomatic gallbladder stones. 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. Offer early laparoscopic cholecystectomy (to be carried out within 1 week of diagnosis) to people with acute cholecystitis. Offer percutaneous cholecystostomy to manage gallbladder empyema when: surgery is contraindicated at presentation and conservative management is unsuccessful. Reconsider laparoscopic cholecystectomy for people who have had percutaneous cholecystostomy once they are well enough for surgery.

Enfield CCG Evidence Summary (Page 2) Managing common bile duct stones 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. For further information the reader is referred to the Clinical Knowledge Summaries organised by NICE https://cks.nice.org.uk.

Enfield CCG Criteria Summary NCL CCG ORGANISATION CRITERIA AVAILALE NOTES Enfield CCG N Barnet CCG Haringey CCG Islington CCG Camden CCG NCL CCG ORGANISATION CRITERIA AVAILABLE NOTES Sandwell and West Birmingham Y It should be noted that whilst a criteria or evidence exists on the Website of a CCG we may or may not have had the opportunity to confirm whether the policy, proposed threshold or evidence has been enacted or remains in place once enacted. We are simply identifying other CCGs who have undertaken a similar exercise to add their evidence to our own. This caused some confusion with the first version of these Evidence Packs. Solihull CCG South East London CCG

Spend & Activity Data including Trend Analysis and Benchmarking Local commissioners working with local people for a healthier future

Enfield CCG Activity & Spend Data 282 Cost 2015/16 £642,670

Enfield CCG Activity & Spend Trend Analysis

Enfield CCG Benchmarking Data

For Further Information contact communications@enfieldccg.nhs.uk or call 0203 688 2814