Quality & Safety Committee 17 th August 2017 Agenda item: 6.2

SUMMARY REPORT ABM University Health Board Quality & Safety Committee 17 th August 2017 Agenda item: 6.2 Subject Improvements in the management of gallstone disease Prepared by Approved & presented by: Hazem Al-Momani, Consultant Upper GI & Bariatric Surgeon, General Surgery, Morriston Hospital Barry Appleton, Consultant General and Colorectal Surgeon, Princess of Wales Hospital Anne Biffin, Clinical Effectiveness & Governance Manager Hamish Laing, Executive Medical Director Purpose The purpose of this report is to inform the Committee of the work being undertaken in the Health Board to improve the management of gallstone disease. Decision Approval Information X Other Corporate Objectives Healthier Communities Excellent Patient Outcomes & Experiences Sustainable & Accessible Services Strong Partnerships A fully Engaged and Skilled Workforce Effective Governance Executive Summary X X X The improvement work at Morriston and Princess of Wales hospitals aims to encourage safer, faster and more cost effective management of gallstone disease by stratification and standardisation of treatment options that avoids unnecessary hospital admissions and reduces risk. Princess of Wales and Morriston have adopted different approaches to address the challenges they face that reflect the differences in workload and intensity of emergency cases at each site. The surgical team at Princess of Wales Hospital is been working with the Royal College of Surgeons Cholecystectomy Quality Improvement Collaborative (CHOLE- QuIC). This collaborative is the Royal College of Surgeons of England s first national quality improvement project. POWH is the only representative from Wales in the collaborative. This is providing the POWH team with the opportunity to employ teambased improvement strategies. 1

A key element of the improvement approach adopted by Princess of Wales Hospital is the establishment of a measurement strategy that enables the team to monitor their progress with minimal time lag. A clinical pathway for the management of gallstone disease has been developed and implemented at Morriston that aims to improve the management of these patients by using case stratification and standardisation of treatment options Key Recommendations The Quality & Safety Committee is asked to note the report. Assurance Framework Next Steps The POWH team is continuing to work as part of the Royal College of Surgeons England s Cholecystectomy Quality Improvement Collaborative (CHOLE-QuIC). They exploring and testing improvements to the management of patient with suspected or confirmed gallstone disease. The Swansea team is planning to introduce a dual consultant on call and a second CEPOD theatre list from September onwards. This will allow both the amber and red category patients to be operated on during their index admission, avoiding delay and readmission. 2

MAIN REPORT ABM University Health Board Quality & Safety Committee 17 th August 2017 Agenda item:6.2 Subject Improvements in the management of gallstone disease Prepared by Approved & presented by: Hazem Al-Momani, Consultant Upper GI & Bariatric Surgeon, General Surgery, Morriston Hospital Barry Appleton, Consultant General and Colorectal Surgeon, Princess of Wales Hospital Anne Biffin, Clinical Effectiveness & Governance Manager Hamish Laing, Executive Medical Director 1. PURPOSE The purpose of this report is to inform the Committee of the work being undertaken in the Health Board to improve the management of gallstone disease. 2. BACKGROUND Gallstone related diseases account for around a third of emergency general surgical admissions and referrals. In October 2014, the National Institute for Health and Care Excellence (NICE) published new guidelines advising that patients presenting with acute cholecystitis should have a laparascopic cholecystectomy within seven days of presentation. The Association of Upper GI Surgeons of Great Britain and Ireland (AUGIS) published its statement regarding these guidelines stating that there are dangers associated with having an acute cholecystectomy more than four days after admission and that the standard should ideally be within three days. The recommendation made in the International Association of Pancreatology / American Pancreatic Association in their 2013 guidelines that all patients with gallstone pancreatitis should have a laparascopic cholecystectomy during their index admission was adopted in the recent AUGIS guidelines. These stated that the standard of care should be a laparascopic cholecystectomy during the index admission for all non-severe cases of gallstone pancreatitis. ABMU, along with other health board and trusts in England and Wales has faced significant problems in meeting the ever-increasing demand for laparoscopic cholecystectomies. The high volume of gallstone disease, along with the shortage of surgical beds due to unscheduled care, mean that unless the way these patients are managed is rationalised patients will wait longer for elective surgery and emergency surgery will be compromised. 3

3. KEY POINTS There is variation in the management of gallstone disease, which reflects the different skills, expertise and experience of the clinician caring for the patient. The improvement work at Morriston and Princess of Wales hospitals aims to encourage safer, faster and more cost effective management of gallstone disease by stratification and standardisation of treatment options that avoids unnecessary hospital admissions and reduces risk. Princess of Wales and Morriston have adopted different approaches to address the challenges they face that reflect the differences in workload and intensity of emergency cases at each site. 3.1 The surgical team at Princess of Wales is been working with the Royal College of Surgeons Cholecystectomy Quality Improvement Collaborative (CHOLE-QuIC). This collaborative is the Royal College of Surgeons of England s first national quality improvement project. POWH is the only representative from Wales in the collaborative. This is providing the POWH team with the opportunity to employ team-based improvement strategies. The defined aim for CHOLE-QuIC collaborators is to achieve cholecystectomy (mainly laparascopic) within eight days for patients with cholecystitis, and within 14 days for pancreatitis or severe biliary colic where clinically appropriate. The collaborative has established low burden measurement strategies to monitor progress. Data are entered into CHOLE-QuIC log and returned to Royal College of Surgeons of England. Live dashboards are available that show performance with minimal time lag. The POWH team is working with colleagues in IT to automate data gathering, which is more laborious than we would choose and thus not sustainable without either improvement or extra resource. POWH aim for weekly meetings of our improvement group to study data and see what learning has arisen, especially when patients have not progressed as rapidly as anticipated. The data collection is intended to drive improvement over time rather than manage performance between centres. However, POWH s measures are currently in the top quartile, which is encouraging. There is no formal pathway to work towards achieving the CHOLE-QuIC aim at POWH. Some of the collaborating organisations have developed pathways for their specific contexts but POWH have chosen not to do this. POWH is currently piloting the approach that is summarised in Appendix 1. To sustain this work it will be important to sustain the Endoscopic Retrograde Cholangiopancreatography (ERCP) service in POW when the current consultant specialist retires. 4

3.2 The Morriston team has developed a Clinical Pathway for the Management of Gallstone Disease based on NICE and AUGIS guideline (Appendix 2). The pathway covers the initial assessment of patients with suspected or known gallstone disease and the management of: o Abnormal liver function test results o Acute cholecystitis o Gallstone pancreatitis o Gallstone related jaundice and cholangitis Following assessment all cases of symptomatic gallstones in Swansea are colour coded red, amber or green to indicate the severity of their condition and the urgency for surgery linked with that category. Patients with gallstone pancreatitis are coded red. In these cases, a cholecystectomy is normally undertaken during the same admission. If this is not possible, the patient is discharged home with a definite date for surgery within 2 weeks of discharge. Patients need to be fit for surgery, and to have sustained a mild pancreatitis, for this rule to apply to them. Those with severe pancreatitis will be allocated a date once they recover from their acute episode. There are currently no guidelines regarding the best time to perform surgery in these patients so each case is addressed individually. The amber category applies to cases of cholecystitis. New guidelines recommend that these patients be operated on within 2 weeks of presentation. The health board is unable to meet these guidelines in Morriston at present due to the difficulty in gaining access to emergency theatres. Surgery is offered to these amber category patients who are medically fit within 2 months of diagnosis. The green category applies to cases of biliary colic listed from outpatient clinics. There are no national/international guidelines on the timing of surgery for this group of patients. They are currently offered surgery within 6 8 months of being placed on the waiting list. Full compliance with the published guidelines is challenging across the health board. In Swansea, the group of patients that are posing the most challenge are the Singleton Hospital patients who are medically unfit and can only be operated on at Morriston. These patients are usually too unwell to have their surgery during their index admission. Once they are discharged home, it is almost impossible to admit them electively to Morriston to have a gall bladder operation as they are competing for beds with emergency and cancer patients. 5

The Swansea team is planning to introduce a dual consultant on call and a second CEPOD theatre list from September onwards. This will allow both the amber and red patients to be operated on during their index admission, avoiding delay and readmission. It is hoped that it will also begin to address the issues of the medically unfit Singleton patients. 4. RECOMMENDATION The Quality & Safety Committee is asked to note that pathways are now established in both surgical admitting hospitals for acute gallstone disease. 6

APPENDIX 1 Management of Acute Biliary Disease at the Princess of Wales Hospital 1 Possible acute biliary patients, admitted by any route, are identified and their unique identifier recorded on a white board in the surgical seminar room. 2 When confirmed to be gallstone disease, usually after an ultrasound scan within 24 hours of admission, without biliary obstruction (jaundice) one of the two identified General Surgeons is informed so that patients can be assessed on the ward or in the Emergency Department / A&E to establish their suitability for surgery. Work is continuing to find a more sustainable, reliable and less individual-dependent process. 3 Patients unsuitable for surgery, unwilling to consent or choosing not to proceed with emergency surgery are treated conservatively with antibiotics/analgesia as appropriate and discharged home when able. Patients found to have cholecystitis who are suitable are listed for emergency surgery. Patients with low risk pancreatitis or biliary colic alone are usually discharged home with analgesia with a date for surgery. The target is to operate within 14 days of discharge. Pancreatitis patients are prioritised over biliary colic patients and allocated the earliest possible date for surgery. 4 Patients listed for surgery are operated on using a combination of emergency (CEPOD) lists and afternoon elective lists. There is a great deal of flexibility in this depending on which consultants are on call and a considerable weight of the emergency gall bladder surgery falls on the two upper GI surgeons who have assisted greatly in the success of CHOLE-QuIC in POWH. 5 Patients with obstructive jaundice or definitely diagnosed common bile duct stones are not included in the CHOLE-QuIC work, but the POWH team has agreed that these patients should be included, at least within the measurement framework that has been established. This is a complex group of patients. Management will be imaging with magnetic resonance cholangiopancreatography (MRCP) and/or Endoscopic retrograde cholangio-pancreatography (ERCP) with stone extraction. Patients will then usually be discharged with a plan for delayed surgery. However, POWH has achieved and is considering a more formal approach to arrange, rapid laparascopic cholecystectomy for more of these individuals as well. 6 In general the POWH team is happy to operate on patients with minimally deranged liver function tests (LFTs) without specific imaging pre-operatively. These patients will usually have an on table cholangiogram and, if stones are identified that cannot be flushed through with glucagon and saline flush, a bile duct exploration will take place if the duct is dilated and one of the upper GI surgeons is available. In the absence of duct dilatation, or when these surgeons are unavailable, the patient will have cystic duct clipped with three clips as a minimum and rapid ERCP performed. 7

Clinical pathway for the management of Gallstone Diseases ABM University Local Health Board Produced by: Hazem Al-Momani Consultant Surgeon Department of Surgery Morriston Hospital January 2016 Review date: January 2018

Glossary Common Bile Duct: CBD Endoscopic Retrograde Cholangio-Pancreatography: ERCP Gallstones: GS Intra-Operative Laparoscopic Ultrasound: IOUS Liver Function Tests: LFT Laparoscopic Cholecystectomy: LC Magnetic Resonance Cholangio-Pancreatography: MRCP On Table Cholangiogram: OTC Ultrasound Scan: USS White Cell Count: WCC Page 2 of 14

Introduction Gall stone (GS) related diseases account for around a third of emergency general surgical admissions and referrals, with this figure only set to rise. In October 2014 the National Institute for Health and Care Excellence (NICE) published new guidelines advising that patients presenting with acute cholecystitis should have a laparoscopic cholecystectomy (LC) within 7 days of presentation. The Association of Upper GI Surgeons of Great Britain and Ireland (AUGIS) published its statement regarding these guidelines and went on to say that there are dangers associated with having an acute cholecystectomy more than 4 days after admission and the standard should ideally be within 3 days. In 2013, the International Association of Pancreatology (IAP) / American Pancreatic Association (APA) published their guidelines recommending patients with gallstone pancreatitis to have LC during the index admission. This stand was adopted in the recent AUGIS guidelines where they stated that the standard of care should be LC during the index admission for all non-severe cases of GS pancreatitis. Page 3 of 14

The need for this pathway ABMU Local Health Board, alongside other health boards and Trusts in England and Wales, has a significant problem in meeting the ever rising demand for LC. This reality is created by the high volume of GS diseases on the one hand, and the shortage of surgical beds due the increasing demands from unscheduled care, both surgical and medical, and shrinking budgets, on the other. These constraints to services alongside the above mentioned guidelines will only lead to the inevitable consequence of longer waiting lists and failures to meet the targets in treating GS both electively, and as an emergency. There is variation in how GS disease is managed reflecting the skills, expertise and experience of the clinician looking after the patient, resulting in differences in management strategies amongst surgeons. This pathway aims to encourage safer, faster and more cost effective management of GS disease by stratification and standardisation of treatment options. Page 4 of 14

Who is responsible for implementing this pathway? It is the responsibility of all clinicians and their teams, involved in the care of patients with GS disease to implement this pathway. If a clinician has expressed his/her wishes not to take part in looking after patients with GS disease, and this decision has been approved by the Clinical Lead, it remains his/her responsibility that this pathway is followed and the necessary investigations/management plans are requested/initiated prior to arranging for the patients care to be taken over by another colleague. Page 5 of 14

Initial assessment of patients with suspected/known gall stone disease 1. Obtain and document a detailed history to establish the diagnosis of GS disease and rule out other differential diagnoses 2. Pay attention to the duration of symptoms and number of previous attacks as this may influence the optimum management plan 3. Assess patient s fitness for surgery and his/her desire for any intervention. Clear documentation of this must be made in the medical records 4. Liver Function Tests (LFT), Amylase and an Abdominal Ultrasound Scan (USS) should be performed in all patients with suspected GS disease 5. The USS report should have as a minimum: Presence or absence of GS Gall bladder wall thickness Presence or absence of biliary tree dilatation +/- diameter of CBD Any other significant/relevant findings 6. Patients who are already known to have gallstones and have normal WCC, LFT and Amylase do not routinely require repeat imaging 7. Offer MRCP (unless contraindicated) in the presence of dilated biliary tree with abnormal LFT. In these circumstances the possibility of CBD stone(s) is high Page 6 of 14

8. Patients with dilated ducts alone (i.e. with normal LFTs) do not require further routine preoperative investigation of their bile ducts as stones in this group are no more common than in the non-dilated GS population (i.e. <5%) Page 7 of 14

Management of abnormal LFTs 1. Patients with abnormal LFTs but normal bilirubin and a non-dilated biliary tract on USS may proceed to directly to LC 1.1. The presence of CBD stones is around 10% in this group of patients and while some surgeons may prefer to have pre-operative identification of CBD stones by MRCP and duct clearance by ERCP prior to LC, Others may proceed directly for LC and OTC/IOUS depending on personal experience and laparoscopic skills level 1.2. Where OTC/IOUS has not been performed and LFTs remain abnormal postoperatively these patients should be investigated by MRCP 2. If CBD stones are found at LC the surgeon has several options 2.1. In the presence of a dilated CBD the patient should ideally have a laparoscopic/open bile duct exploration 2.2. In the presence of a non-obstructed biliary tree, the cystic duct should be secured and the patient offered post-operative ERCP during the same admission. NEVER EXPLORE A NON-DILATED CBD 3. Patients with a CBD >10mm and abnormal LFTs with an elevated bilirubin represent those at highest risk of CBD stones and pre-operative MRCP should be offered Page 8 of 14

Acute cholecystitis 1. Patients with acute cholecystitis should be admitted to hospital to have fluid resuscitation, antibiotics and analgesia 2. The diagnosis of acute cholecystitis is a clinical one with a consistent history of ongoing pain and tenderness in the RUQ, usually accompanied by a raised temperature and inflammatory markers 3. Patients diagnosed with acute cholecystitis should ideally have their LC on the same admission within 72 hours 3.1. Surgery for this sub-group of patients may be very challenging and is associated with a higher incidence of complications (particularly beyond 96 hours) and a higher conversion rate to open cholecystectomy 3.2. These patients should be operated on by surgeons with experience of operating on patients with acute cholecystitis 3.3. This is preferable to leaving them for a delayed procedure. 4. Patients with persistent and / or increasing biliary pain, but without systemic inflammatory response, should be managed in the same way as patients with acute cholecystitis i.e. by early LC 5. Patients with signs and symptoms of acute cholecystitis who are unfit for general anaesthesia and surgery who do not improve with antibiotics with clinical or radiological evidence of empyema, may be treated by percutaneous cholecystostomy 6. If LC could not be offered in the index admission and the patient shows evidence of improvement ( both clinically and on blood tests), the patient should be added to the waiting list for a LC Page 9 of 14

6.1. When adding these patients to the waiting list it should be stated on the waiting list card that they fall into the Amber category 6.2. It should be aimed to offer patients in the Amber group a LC within 8 to 12 weeks of being added to the waiting list 6.3. If surgery was not offered within 72 hours since the onset of symptoms, it should be delayed till after 8 weeks to allow for the inflammatory process to settle which allows for a safer operation 6.4. If while waiting for an elective LC the patient represent with acute cholecystitis, the clinician responsible for the patient s care should consider bringing the date of surgery forward Page 10 of 14

Gall stone pancreatitis 1. Patients with gallstone pancreatitis should be admitted for resuscitation and further assessment 2. Those with predicted mild disease can be managed on a general ward, and should be allowed to eat and drink as tolerated with adequate analgesia and anti-emetics as required 2.1. LC should be arranged ideally during the same admission once the pancreatitis has resolved 2.2. If it is not possible to arrange for a LC during the same admission, the patient can be discharged home once pain is controlled and they are able to eat adequately 2.3. Once discharged, these patients should be booked on the waiting list as category Red and ideally these patients should be sent home with a preset date for LC 2.4. If a preset date was not offered on discharge, every effort should be taken to offer LC with 2 to 4 weeks from the attack of pancreatitis 3. Patients with severe or predicted severe disease should be carefully monitored for development of organ failure with early input from critical care team/pancreatic surgery team 3.1. Arrange early review/ admission by critical care unit 3.2. Early Ultrasound should be performed to confirm the presence of gallstones to guide subsequent management 3.3. Those with predicted severe disease will require a CT between 7 10 days of admission, or if the CRP is rapidly rising, to determine the presence of pancreatic necrosis. Page 11 of 14

3.4. Early ERCP should be considered where there is co-existing cholangitis or ongoing biliary obstruction. 3.5. When the patient is constitutionally and physiologically well, they should undergo LC and OTC/IOUS 3.6. A CT of the pancreas may sometimes be helpful to look for peripancreatic fluid collections or complications that may make early LC more difficult. In this scenario surgery may need to be deferred until symptoms and inflammatory markers are settling. Recurrent acute pancreatitis before full recovery in the setting of severe acute pancreatitis is rare and it is reasonable for the cholecystectomy to be delayed Page 12 of 14

Gall stone related jaundice and cholangitis 1. Patients with abnormal LFTs, dilated bile ducts and sepsis have cholangitis and should start immediate IV antibiotics and undergo urgent ERCP and decompression of the bile duct 2. Patients with jaundice and an obstructive or mixed picture of elevated LFTs should undergo US to confirm the presence of gallstones and dilated bile ducts. A careful history and examination for signs and symptoms of malignant disease are important. A CT scan is indicated to diagnose malignant disease where suspected or when US shows no GB stones. 3. Patients with jaundice and suspected CBD stones should proceed to ERCP and stone extraction within a few days of diagnosis. In-patient admission is not always necessarily required if systemically well, drinking freely and without signs of sepsis 4. Patients who have had previous ERCP for CBD stone disease +/- have a biliary stent in situ should be treated with antibiotics and proceed to urgent ERCP for stent change or duct clearance as the incidence of residual stones/debris is high even when the duct was thought to be cleared 5. Cholecystectomy is recommended after ERCP for jaundice or cholangitis secondary to CBD stones 5.1. This may be done during the index admission or delayed Page 13 of 14

5.2. If added to the waiting list, these patients should be booked as category Amber and surgery should be carried out within 12 weeks of going on the list 5.3. Laparoscopic cholecystectomy after cholangitis is usually a very challenging procedure and should be undertaken by an experienced surgeon. Page 14 of 14