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List of statements
Policies1. Endoscopy units that offer ERCP should have a dedicated written policy covering administrative processes and common clinical scenarios.
Patient Journey
Referral2. ERCP units should utilise dedicated ERCP request forms that contain a minimum dataset to determine suitability for the procedure. Units should use standardised electronic request forms, but where that is not possible in the immediate future, paper forms should be legible, complete and patient demographics typed.
Vetting3. Before an ERCP procedure is booked, the referral should be vetted for appropriateness by a member of the ERCP team, with final responsibility for this by an ERCP consultant. Where the information on the request is insufficient to determine appropriateness, further information should be sought from the referrer or the medical records before the procedure is booked.
4. Where the indication for ERCP is uncertain, this should be discussed in a local and/or regional MDT. If a patient attends for ERCP and the indication for the procedure is unclear or may have changed, the procedure should be deferred pending further discussion or investigation.
5. All patients should be assessed for fitness for the procedure and to ensure that the correct blood tests and adjustments to medication have been made. For out-patients this can be via a nurse-led preassessment team. For in-patients, this should be by a ward visit by a member of the ERCP team.
Booking6. Outpatients should be booked sufficiently early in the day to facilitate same-day discharge.
7. All patients with CBD stones and jaundice should be treated within 72 hours of diagnosis and units should audit their compliance with this.
8. Units should identify the specific waiting times for patients requiring anaesthetic procedures and there should be a process for tracking planned stent removal/exchange procedures with an escalation policy if there are delays.
9. Booking policies should be stated in the unit SOP.
Consent10. All outpatients having ERCP should have access to discuss the procedure face to face or over the phone with a member of the ERCP team in advance of attending for the procedure. This should be supplemented by written or online material. All in-patients should receive a visit from a member of the ERCP team prior to attending the unit.
11. Despite the often urgent nature of ERCP, units should take steps to adhere to the requirements of unrushed and private consent conversations as outlined in the BSG guidelines on consent.
12. ERCP-trained nurses and other members of the ERCP team can contribute to patient information, assessment and the consent process throughout the patient journey but the final confirmation of consent should be by an ERCP endoscopist.
Case Preparation13. Careful attention to preprocedure preparation should include reviewing radiology, checking blood results, medication, cardiac devices, ensuring the patient is hydrated with intravenous fluids and that the necessary support specialties are notified in advance of the procedure. Specialist radiological support should be available to review imaging where required.
Patient Safety14. Before any ERCP list, a full team briefing should occur. This should involve all members of the team (endoscopist(s), nursing team, radiographer anaesthetist) in which cases are reviewed, potential difficulties highlighted and potential equipment (including endoscope) requirements reviewed.
15. Before each ERCP procedure a minimum of a sign-in and time-out should occur that should include all of the basic endoscopy requirements (e.g. identification, consent) but also components specific to ERCP (e.g. clotting, pregnancy checks).
16. Whenever a stent is to be used, there should be a further time-out in which it is checked that the correct stent is being used and is in date.
17. Debriefs should occur at the end of lists and should focus on good practice and discussion about adverse events.
Teamwork18. A focus on teamwork to foster a welcoming, just and learning culture in the ERCP room should be developed in all ERCP teams. Lists should be booked to avoid fatigue, with the provision of breaks and access to support staff.
Complications19. Unit policies for prevention and recognition of complications from ERCP should be enshrined in the written unit SOP. A culture of early recognition of complications during and after the procedure should be encouraged and enhanced through team-based training.
Recovery20. Patients should be recovered in a suitable environment, equipped and staffed by nurses trained in recognising adverse events related to ERCP. Four hours is the minimum recommended recovery period, although in some selected cases 2 hours may be sufficient.
Discharge21. Patients should receive information about their procedure and next steps in a private room once they have recovered from sedation. Written discharge information should be provided that gives advice about ERCP-specific adverse events and how to contact the hospital in the circumstance of developing such symptoms.
Stent Tracking22. Trusts need to ensure that there is a reliable system in place for tracking patients with stents that require removal or exchange and ensuring that this is performed on time.
The ERCP Team
Nursing23.Each unit should have a list of nurses whohave received training and are competent to lead an ERCP list. Nurses who lead ERCP lists should receive specialist training in hepatobiliary anatomy, ERCP indications, complications and equipment.
24. ERCP units should identify the competencies, training and credentialing needs (supported by the network) of ERCP nurses and ensure that nurses leading an ERCP room have received appropriate training and been signed off as competent.
25. ERCP nurses should have access to audit and CPD sessions both online and at face-to-face meetings, supported by an appropriate budget.
26. Nurses who lead ERCP rooms should have regular updates on the use of equipment at a minimum every 6 months. A network approach to this should be developed and nurses supported to be released to attend local specialist centres in order to achieve this.
27. ERCP lists should be supported by a minimum of three staff. Two must be registered healthcare staff and 1 must be a registered nurse. One member of staff should be trained in leading ERCP lists.
28. Each ERCP unit should have a named lead ERCP nurse that is responsible for supporting the training and mentoring of other ERCP nurses, troubleshooting equipment problems, ensuring appropriate stock levels and supporting governance processes within the unit.
29. Units should develop and support the expanding role of specialist nursing in ERCP to support patient preassessment and postprocedure care, especially for inpatients.
30. ERCP units should implement nurse preassessment for outpatient ERCP.
31. ERCP networks should identify a lead ERCP nurse to support training and movement of nurses between ERCP units within the network.
Management32. An ERCP service should be supported by a triumvirate of lead ERCP endoscopist, lead ERCP nurse and a member of the management team who is identified in assuring the quality of the ERCP service.
33. The lead ERCP manager should have roles in waiting list management (and publication), list booking, staffing levels, equipment management and supporting governance and CPD.
34. List numbers and capacity should be monitored and there should be an action plan in the ERCP SOP if numbers fall below a defined level.
Patient35. Feedback from patients who have had ERCP should be sought and fed back to unit and network governance meetings.
Supporting Specialities36. Specialist radiological support should be available to review imaging prior to ERCP for all units.
37. Where MDT input is required, radiological and surgical input should be available.
38. Urgent access to acute surgical and IR expertise should be available for all units, either locally or via network pathways, defined in the unit SOP.
39. Anaesthetic support for emergency or clinically unstable cases should be available in all units.
Continuous Professional Development40. All endoscopists performing ERCP should have adequate time for specific ERCP-related CPD agreed in their job plans, which should include a minimum of 4 hours a month. The content and reflective learning from CPD should be available at annual appraisal.
Key Performance Indicators41. All units providing ERCP must have in place governance arrangements that specifically focus on ERCP practice. This must include a designated medical governance lead with adequate job planned time. This must also include regular and documented review meetings with relevant members of the MDT. The clinical governance arrangements must include as a minimum a retrospective review of:
30-day complication and mortality rates.
incidents.
complaints and compliments.
risk management.
patient experience.
42. Referral centres should put in place systems that enable M&M reviews of patients who might have experienced readmissions to other units.
43. All units providing ERCP must carry out regular quality and safety audits of the ERCP service that cover the key quality and safety standards outlined in this document.
44. All units providing ERCP must have a designated medical clinical lead for ERCP who is responsible for ERCP service delivery and governance. This role should be supported by adequate job planned time.
45. All units performing ERCP should have an agreed process for determining and addressing endoscopist under-performance or safety concerns.
46. Individual ERCP endoscopists should perform a minimum of 100 procedures per annum and ERCP units should perform a minimum of 200 procedures per annum. Where a unit or individual does not meet the required numbers this should be reviewed by clinical or network leads and written plans developed to correct this.
Equipment and Facilities47. ERCP should be performed in dedicated fluoroscopy rooms with sufficient space to accommodate the endoscopy, radiology and, where required, anaesthetic teams and their equipment.
48. The ERCP room should be located in a space where there is prompt access to all of the equipment that may be needed during the procedure and which promotes efficient patient flow.
Ergonomics49. Appropriately sized lightweight leads should be available for all staff participating in ERCP.
50. Room design should allow sufficient space for equipment storage and preparation and should be optimised to minimise musculoskeletal strain on staff participating in ERCP.
Fluoroscopy and Radiation Protection51. Fluoroscopy equipment used for ERCP should be of sufficient standard that allows real-time analysis of images and visualisation of ductal anatomy to the level required for the procedure.
52. Radiation doses should be recorded for individual procedures, and radiation exposure to staff should be monitored using dosimeters. These should comply with local standards for radiation dosing and protection.
53. All units should provide a radiation safety or equivalent course with attendance mandated for all those working with ionising radiation.
54. Adequate PPE should be provided including eye protection glasses for all procedures.
X-Ray Acquisition55. Standard images at each ERCP should include a control image, a cholangiogram and a final full abdominal exposure at the completion of the procedure. In addition to this, for cases of stone disease, a further cholangiogram should be taken confirming duct clearance where it has occurred.
56. Further images should be taken to demonstrate pathology encountered and significant events during the procedure.
Duodenoscopes and Accessories57. There should be a sufficient number of duodenoscopes with adequate processing facilities to reduce the risk of duodenoscope-associated infections and support a full (4 cases) ERCP list without delays due to reprocessing.
58. Staff should be trained to use the available equipment in the unit, especially those items that are used less frequently.
59. Dedicated systems should be available for stock management to ensure continuous availability of all equipment based on the complexity of ERCP being performed in individual units.
Deep Sedation and General Anaesthesia (DS/GA)60. Access to adequate numbers of DS/GA lists should be available regularly across organisations or networks.
61. Patients should be prioritised for DS/GA based on patient tolerance, the complexity of the procedure and patient factors, including the need for emergency ERCP or in unwell patients. If DS or GA are required but not available in the local hospital, facilities should be available to transfer the patient to an organisation that can provide this.
Networks and MDT62. ERCP services should work collaboratively within a region, health board or integrated care board in a hub-and-spoke model with clear and formalised leadership and terms of reference.
63. Each network should develop and agree a pathway of care encompassing preprocedure, procedure and postprocedure care and data collection.
64. Each network should have a regular MDT to discuss complex or challenging cases, to which all units from the network should have access.
65. Each unit should participate in a network CPD/audit day at least annually. In addition, every unit performing ERCP should have regular M&M/audit meetings that include all members of the ERCP team.
66. Each network should agree formal protocols and pathways for the management of common pancreaticobiliary conditions.
67. Each network should develop and agree cover/backfill arrangements to maximise use of capacity to minimise patient waiting times and travel distance.
68. Each network should develop and agree measures to enable cross unit working of medical and nursing staff to enhance training.
69. Each network should develop and agree in collaboration with regional HPB service criteria a pathway for biliary drainage within 24 hours in urgent cases.
70. Each network should ensure that practitioner and unit annual volume are audited and the minimum numbers of 100 and 200 cases, respectively, is achieved as soon as feasible.
IntroductionEndoscopic Retrograde Cholangiopancreatography (ERCP) is one of the highest-risk procedures performed routinely by endoscopists. ERCP services in England were last subject to national audit and survey in 2007.1 In 2014, the British Society of Gastroenterology (BSG) published a Standards Framework outlining key performance indicators (KPIs) for ERCP practitioners, for service provision and for training programmes.2 This was followed by a repeat Census in 2016 from 234 ERCP units via the Joint Advisory Group (JAG) Global Rating Scale (GRS) that highlighted significant shortfalls in comparison to the Standards Framework.
ERCP practice has evolved in response to recognition of an ageing population and technical advances. ERCP should almost always be performed with therapeutic intent with safer diagnostic options such as MR cholangiopancreatography (MRCP) or endoscopic ultrasound (EUS) being routinely available, whereas new developments such as intraductal cholangioscopy and therapeutic EUS have expanded the range of available therapeutic options.
The Getting it Right First Time (GIRFT) gastroenterology review identified variations in case selection, access to multidisciplinary teams (MDTs), systems for tracking biliary stent removal and variation in outcomes related to stone disease and mortality in different Trusts.3 The document highlighted the need for ERCP MDTs and to consider consolidation of services across centres. Furthermore, a recent draft white paper from National Health Service (NHS) England (NHSE) has stressed the need to enhance quality and organisation of ERCP practice into regional networks and MDT work.
Over the last decade, a number of clinical guidelines and standards have been published by the BSG, National Institute for Health and Care Excellence (NICE) and European Society of Gastrointestinal Endoscopy (ESGE) that have produced a range of recommendations and KPIs related to ERCP, adverse events, safety and common bile duct (CBD) stones.4–10 These recommendations have not been subject to rigorous implementation and the process by which clinical outcomes and complications data should be collated by Trusts and individuals has not been described.
The most common clinical indication for ERCP remains CBD stones yet duct clearance is variable, with residual stones common and repeat procedures performed more frequently than is recommended. There is also currently no clear guidance on the performance of sphincterotomy and verification of duct clearance.11–13
ERCP services, in common with other areas of endoscopy, are under pressure. ERCP is about far more than just the technical skills of the practitioner, requiring referral pathways for complex cases, preassessment of patients, thorough consent, complex clinical decision-making, team-based preprocedural, periprocedural and postprocedural management, systems for managing complications and input from other specialists including interventional radiology (IR). Errors leading to harm can occur at any point in the complex patient pathway.14 ERCP endoscopists are required to fulfil many roles within gastroenterology, general surgery or radiology and may not have sufficient time devoted to ERCP-specific continuing professional development (CPD) and governance. Patient outcomes may be compromised by outdated equipment and facilities and inadequate access to anaesthetic supported lists.15 Updated General Medical Council (GMC) and BSG guidance on consent and a recent coroner’s inquest into post-ERCP deaths have highlighted the need for robust systems within hospitals to ensure appropriate patient selection and individualised consent.16–18 It is in response to these multiple drivers that we have set out to describe the components of a high-quality and safe ERCP service.
MethodsFollowing a recommendation from the BSG Endoscopy (BSGE) committee and endorsed by the BSG Executive, an ERCP Project Group was established in 2021 within the BSGE Endoscopy Quality Improvement Programme (EQIP). Following this, a group of stakeholders were invited to form an advisory group (AG). Members of the AG were selected to meet requirements of equality, diversity, geographical variation, surgical, medical and nursing groups and referral/non-referral centres. Patients who had participated in a series of stakeholder interviews were approached and volunteered to participate in the AG.
We took a multimethod approach to understanding ERCP delivery in the UK, involving collecting survey data and conducting discussion groups with, nurses, endoscopists and patients.
Two national surveys of ERCP practice were disseminated by the BSG. These surveys audited current clinical practice and sought to understand variation in practice, process, facilities, resources and adherence to guidelines across ERCP nationally. One survey was targeted at ERCP practitioners (individual) and the other at endoscopy units (organisational) to gain a complete understanding of practice at an individual and unit level. There were nine open-ended response questions related to priorities for service improvement and barriers to change. Descriptive statistics of fixed characteristics were calculated for both surveys. Free-text responses were categorised, and the frequency of different reported issues was calculated. Response rates from each survey were high indicating that the data used here are a fair reflection of current practice. All 170 UK endoscopy units identified responded to the survey (100%) and a 74% response rate to the individual ERCP practitioner survey was achieved (389/526 respondents). Selected data from these surveys are reported here to support the statements. Full details of the surveys and comprehensive analysis of the findings will be the subject of further publications in the near future.
In order to understand the factors underpinning the variations identified in the surveys and any concerns stakeholders might have with approaches to standardisation of practice and quality improvement processes, a series of discussion groups were held in summer 2023, in which the key areas examined in the survey were considered by a range of stakeholders with varying experience, specialisms and perspectives. Discussion groups were arranged by specialism (endoscopists, endoscopy nurses and public/patient) and provided a forum to understand the experiences of these individuals; to integrate their perspectives into the EQIP; understand underlying issues which may contribute to some of the survey findings and consider potential strategies to improve practice. As for the surveys, selected results from these discussion groups are presented here while detailed analysis will be subject to future publication.
Following the survey and stakeholder interviews, priorities for a high-quality and safe ERCP service were identified and collated into a draft manuscript and series of statements by the project group. A first draft was shared with the AG in February 2024. Initial feedback was sought via a structured online questionnaire and used to inform a face-to-face meeting, held in London in February 2024. A combination of nominal group techniques and facilitated small group work were employed to determine areas of agreement or disagreement. Where there was disagreement, the statement was amended prior to repeat discussion and ratification at an online meeting with the AG in April 2024 in which all statements were confirmed. Only statements for which there was 100% agreement are included here.
Due to the paucity of high-quality evidence, this is not a guideline; in accordance with limitations to the Grading of Recommendations Assessment, Development and Evaluation approach in this circumstance, we have provided good practice statements rather than recommendations, written from the perspective of what a patient would wish when entering an ERCP service.19
Key components of a high-quality ERCP serviceDocuments and policiesThe survey demonstrated that 75% of organisations have written policies and guidelines covering clinical pathways, 68% have processes covering administrative pathways for ERCP, 23% have written policies on requesting removal of temporary stents, 44% have written guidance that eligible patients undergoing ERCP receive rectal non-steroidal anti-inflammatory drugs (NSAIDs) and 3% have written policies on the insertion of pancreatic duct stents for prophylaxis.
There is, therefore, significant variation and while standard operating policies (SOPs) do not guarantee optimum practice, they should reduce variation in clinical practice, provide clarity of process and transparent assurance to external reviewers of a standard approach within the unit. Lack of SOPs was identified as a key contributing factor in non-procedural patient safety incidents in England and Wales.14
While this document outlines the general principles of a high-quality and safe ERCP service, it is recognised that individual units will find their own solutions to each statement. Thus, all units performing ERCP should have a dedicated written policy covering common clinical scenarios and processes. This should include, but not be limited to, vetting for appropriateness, preassessment, consent, safety policies including use of safer surgical checklists and implant time-outs, booking policies, adherence to published ERCP guidelines, prophylaxis against post-ERCP pancreatitis, arrangements for follow-up procedures and stent removal tracking processes. This can be part of the overarching endoscopy policy or separate but should be clearly identified as relating to ERCP practice. Table 1 outlines the recommended components of a unit ERCP SOP.
Table 1Key components of an ERCP unit SOP
Statement1. Endoscopy units that offer ERCP should have a dedicated written policy covering administrative processes and common clinical scenarios.
Patient journeyPreprocedureCase selection
Referral mechanismsBooking procedures at the appropriate time and on the correct list is essential to maximise timeliness and efficiency. Delays and errors will occur where the information on the referral is incomplete or illegible.
58% of units receive all referrals on electronic booking forms while the remainder use either paper-based request forms or a combination of the two. There are numerous advantages to electronic request forms including the requirement to complete certain sections, legibility, speed, the presence of an audit trail and moving towards a paperless work environment. There are several applications that can be used for electronic referrals and we recommend that all units move towards one of these.
37% of organisations receive referrals from neighbouring hospitals. This may provide greater challenges in incorporating electronic referrals across different IT networks. Nonetheless, we recommend that networks collaborate to provide digital solutions in the near future.
Where institution of electronic referrals is not immediately possible, requests should be made on standardised ERCP request forms that include all relevant information that permits vetting for appropriateness (see below) such as comorbidities, relevant anticoagulation drugs, American Society of Anaesthesiologists classification, relevant blood results and capacity to consent. Referrals should be rejected if incomplete or illegible and patient demographics should be typed (or patient sticker) to avoid transcription errors. The components of an ERCP request form, which contains what may be considered a minimum dataset to facilitate vetting, can be found in table 2.
Table 2Minimum elements of a standardised patient referral form for ERCP
Statement2. ERCP units should use dedicated ERCP request forms that contain a minimum dataset to determine suitability for the procedure. Units should use standardised electronic request forms, but where that is not possible in the immediate future, paper forms should be legible, complete and patient demographics typed.
Vetting for appropriateness and preassessmentAfter receipt of the referral, procedures are vetted for appropriateness by an ERCP consultant in 85% of units. However, in the remaining 15%, a variety of solutions are employed, including trainees and nurses. The need to avoid assessment of the appropriateness on the day of the procedure is essential to prevent late cancellations, or, worse, proceeding with an unnecessary procedure. This is reflected in recent BSG guidance on consent and a Coroner’s inquest in 2021 into post-ERCP deaths criticised a lack of robust auditable vetting pathways.16 18
Thus, there must be a system in place that ensures that all patient factors relevant to the clinical indication for, and safety of, ERCP are identified in advance of the procedure and capture what information has been considered as part of this process. Such considerations should include whether the procedure is indicated on clinical grounds, likelihood of success (eg, the presence of altered anatomy) and patient factors such as fitness to undergo the procedure, prior procedures, capacity to consent or the requirement for anaesthetic. Vetting for appropriateness should be performed by someone from the ERCP team who is adequately trained in ERCP and its indications before a procedure is booked. Although this process can be delegated, final responsibility for any vetting decision is with a nominated ERCP consultant. Where this process is delegated, this should be described in the unit ERCP SOP.
A specific situation in which ERCP can be avoided is where bile duct stones have passed. Recent large case series have demonstrated that where ERCP is delayed 2–7 days after imaging detected stones, these stones will have migrated on up to 22% of occasions, particularly where stones are single and small (<5–6 mm).20–22 Where there is a reasonable possibility that this may have occurred, or where there is uncertainty on imaging, this should be identified at the time of vetting. Options include performing a check EUS immediately prior to ERCP, although only 37% of units offer this on some or all lists. Lack of available EUS should not, however, deter endoscopists from delaying an elective procedure, for example, to repeat an MRCP or refer to a centre where EUS can be performed.
Some indications for ERCP are uncertain, depend on local expertise or may require referral to a specialist centre. Examples may include hilar strictures, primary sclerosing cholangitis, postsurgical anatomy and large or difficult CBD stones. Wherever the indication is uncertain or may require a referral, the case should be discussed in a local or regional MDT setting. Lack of MDTs for ERCP procedures was identified in the GIRFT report and it is essential that all units have access to a local and/or regional referral MDT.3
Many patients requiring ERCP are in hospital. These patients are often under the care of teams who may not be familiar with the demands and risks of ERCP. These patients are frequently sick, frail, have significant comorbidities and are more likely to lack capacity than outpatients. In 29% of units, a consultant routinely reviews inpatients on the ward, whereas in 20% of units, there is no routine process for reviewing patients prior to the procedure. Assessment of fitness for the procedure prior to the patient attending the unit is essential. Thus, it is important that all units institute a system whereby inpatients are reviewed by a member of the ERCP team on the ward prior to attending the department for the procedure.
Patients being transferred from other units pose significant challenges in this respect and units must satisfy themselves that they have sufficient information relating to the patient’s indication and fitness for the procedure before transfer. While not commonplace now, the institution of video assessment and consultation of patients in remote units should be considered prior to transfer.
For outpatients, nursing preassessment is important to troubleshoot any problems on the day of the procedure and to make arrangements for the management of coexisting medical conditions such as anticoagulation therapy or diabetes. Preassessment allows the opportunity to ensure that the necessary blood tests (eg, coagulation and renal function) have been checked prior to the procedure. This is currently available in 64% of units whereas this should be universally instituted.
Statements3. Before an ERCP procedure is booked, the referral should be vetted for appropriateness by a member of the ERCP team, with final responsibility for this by an ERCP consultant. Where the information on the request is insufficient to determine appropriateness, further information should be sought from the referrer or the medical records before the procedure is booked.
4. Where the indication for ERCP is uncertain, this should be discussed in a local and/or regional MDT. If a patient attends for ERCP and the indication for the procedure is unclear or may have changed, the procedure should be deferred pending further discussion or investigation.
5. All patients should be assessed for fitness for the procedure and to ensure that the correct blood tests and adjustments to medication have been made. For outpatients, this can be via a nurse-led preassessment team. For inpatients, this should be by a ward visit by a member of the ERCP team.
Timeliness, list booking and waiting list managementBooking of ERCP lists often involves a combination of procedures from both inpatient and outpatient sources, sometimes with transfers from other units and a variety of urgency ranging from planned elective procedures to very urgent (<24 hours) acute inpatients. Added to this, procedure complexity can vary substantially and an increasing number are referred for deep sedation or general anaesthetic (DS/GA) lists. Booking an ERCP list and managing the waiting list is, therefore, more complex than for many other endoscopy procedures.
The GIRFT report identified that there was a significant variation in the percentage of day-case ERCP procedures performed per unit, with some centres having very low rates.3 Owing to the extended time to recover and monitor patients after the procedure, some units may struggle to offer same-day discharge to outpatients booked beyond a certain time in the day. Where this is the case, units should prioritise booking outpatients earlier in the day to ensure that the patient can be recovered and discharged the same day and there should be a written policy for this in the SOP.
While the time taken to complete an ERCP can vary considerably, a standard approach to time allocation per procedure should be adopted by units to allow optimum use of list capacity without frequently overrunning. However, where it can be anticipated that a procedure will take significantly longer (eg, a large bile duct stone requiring advanced therapeutics) this should be identified at the time of vetting for appropriateness to allow the correct time allocation at booking.
NICE 2015 Quality Standard 104 states that ‘adults with CBD stones who need emergency ERCP should have it within 24 hours’. Currently, very few units or networks are able to provide 7 days per week access to ERCP. Nonetheless, a solution to this Standard should be an objective in the planning of networks in the near future.
The Standard also states that ‘adults with CBD stones causing jaundice should have ERCP within 72 hours of diagnosis’.5 The majority of units (85%) are compliant with this most of the time (>50%) but only 35% report being compliant almost all of the time (>90%). Furthermore, only 42% of units audit their compliance with this Standard. Given the significance in relation to patient outcomes, it is essential that units find ways to achieve this. In smaller units, this may be through the use of networks to improve timeliness. All units should audit their compliance with this and examine the components of the pathway if there are delays (eg, from diagnosis to referral and from referral to procedure).
There are a number of circumstances where stents may be left in situ for a defined period of time before removal or replacement. Delaying such procedures can lead to significant and potentially lethal clinical consequences due to sepsis from blocked stents or buried irretrievable stents. The GIRFT report identified that there is variation in effective surveillance for patients with biliary stents and only 62% of Trusts were running a database system to track patients with removable biliary stents.3 In the organisational survey, 23% of units have written policies on requesting removal of temporary stents and a variety of processes are followed. Tracking to ensure stents are removed or replaced when necessary is essential to reduce the risk of biliary sepsis. Thus, departments must have a reliable means to track the booking of these procedures. Where planned procedures are delayed beyond their expected booking date this should be identified and escalated.
Lack of anaesthetic provision may also lead to delays in these procedures potentially with significant consequences. Units offering anaesthetist-supported procedures should monitor and declare the waiting times specifically for these procedures.
Statements6. Outpatients should be booked sufficiently early in the day to facilitate same-day discharge.
7. All patients with CBD stones and jaundice should be treated within 72 hours of diagnosis and units should audit their compliance with this.
8. Units should identify the specific waiting times for patients requiring anaesthetic procedures and there should be a process for tracking planned stent removal/exchange procedures with an escalation policy if there are delays.
9. Booking policies should be stated in the unit SOP.
ConsentFrom the organisational survey and the stakeholder interviews, it is evident that consent processes vary substantially among units, with examples where the required standards as laid out in the latest BSG and ESGE guidance and stipulated clearly in the recent Coroner’s inquest are not met.16 18 23 24
19% of units report that the consent form for ERCP may be completed by a nurse. While this is commonplace for simpler procedures, the latest BSG guideline update recommends that ‘The person completing the consent form …. will depend on the specific procedure but for high-risk procedures will require either considerable personal experience in the procedure or dedicated training that should be formally approved through local governance procedures’.16
For outpatients, preprocedure information is provided in a clinic by 57%, whereas postal information is provided in 81% and online resources in 9%, with some units combining approaches. The form is signed in clinic in only 5% whereas the majority complete the form in the endoscopy unit on the day. The BSG Consent guideline update states that ‘The location in which consent is confirmed on the day of the procedure should be confidential, in a different location to the endoscopy treatment room and offer sufficient privacy and dignity to allow the patient to consider their decision’.16 By contrast, the survey demonstrated that for outpatients the form is signed in a shared space by 26% of patients. For inpatients, a preprocedure visit to offer information with a doctor, nurse or fellow is provided in 54% whereas the remainder relies on information provided to the patient on the ward by the referring team. The consent form is signed on the ward in 40% whereas 29% use a shared space in the endoscopy unit to complete the consent discussion with either an ERCP doctor or specialist nurse.
In our stakeholder groups, patients reported disappointment with the level of communication and lack of opportunity to ask questions about ERCP and its associated risks prior to their procedure. Patients reported that a combination of a face-to-face consultation and leaflet to take away was felt to be ideal as this gave people information to reflect on. Patients who underwent emergency ERCPs often felt that there was minimal explanation of risk and complications. However, these patients also noted that the urgency of their condition meant that it was not possible to take time for decision-making and consider risks. Also, being in considerable pain, or on strong painkillers, meant that they felt they could not have taken in, and reflected on, detailed information at that time.
It is evident that, despite clear guidance from BSG, ESGE, legal precedent and clear preferences from patients, many units struggle to meet the demands of informed consent for this particularly high-risk procedure.
All outpatients having ERCP should, at a minimum, have access to discuss the procedure face to face or over the phone with an ERCP endoscopist or an individual from the ERCP team who has received dedicated training in individualised ERCP consent in advance of attending for the procedure, supplemented by written or online material. This gives the opportunity to discuss the procedure with the patient and review the indication, which may lead to altered treatment plans. The choice of face to face or over the phone will depend on patient preferences and practicality based on distance from the hospital and urgency of the procedure. Ideally, the patient would sign the consent form before attending the unit for the procedure. However, where this is not practical, this should occur in a private space in the unit, as outlined in the BSG guidelines.
All inpatients should receive a visit from a similarly trained individual from the ERCP team prior to attending the unit. This will also allow adequate preassessment and consideration of fitness for the procedure. While the emergency nature of ERCP may make it difficult to meet these standards in some patients, this should be the exception and not the rule. Many inpatients attendingfor ERCP will do so on a trolley and often await the procedure in busy recovery units. If this is the case it is essential that the patient has the opportunity to read and sign the consent form before attending the unit, with the exception of rare emergencies.
Units receiving patients transferred from other hospitals should ensure the principles of informed consent are adhered to and that the patient receives appropriate information and discussion from the host team, supplemented by remote consultation as required.
At present, there is no clearly defined curriculum or framework to describe training in ERCP consent for non-ERCP endoscopists. This should be a priority going forward but, in the meantime, consent discussions with clinicians who are not ERCP endoscopists should be confirmed and countersigned by an independent consultant ERCP endoscopist prior to the patient entering the procedure room.
Statements10. All outpatients having ERCP should have access to discuss the procedure face to face or over the phone with a member of the ERCP team in advance of attending for the procedure. This should be supplemented by written or online material. All inpatients should receive a visit from a member of the ERCP team prior to attending the unit.
11. Despite the often urgent nature of ERCP, units should take steps to adhere to the requirements of unrushed and private consent conversations as outlined in the BSG guidelines on consent.
12. ERCP-trained nurses and other members of the ERCP team can contribute to patient information, assessment and the consent process throughout the patient journey but the final confirmation of consent should be by an ERCP endoscopist.
ProcedureCase preparationPatients attendingfor ERCP frequently have significant comorbidities and may be sick from jaundice or cholangitis. It is essential that the patient is as well as possible in order to tolerate the demands of the procedure along with sedation or anaesthesia. In selected cases at risk of decompensation, or those in critical care units, preprocedure anaesthetic review should be available. Careful attention to the patient’s medication is required to ensure that they fulfil the requirements of the BSG guidelines on antiplatelet and anticoagulant medication.25 Patients isolated for infection control issues should be identified so that the necessary arrangements can be made in the department.
Frequently patients will be at risk of dehydration from prolonged fasting prior to the procedure so measures to ensure that patients receive intravenous fluids before attending the unit will minimise this risk and is strongly encouraged. Up-to-date blood test results should be made available and checked including where relevant, coagulation screen, renal and liver function. Pacemaker and cardiac devices should be identified in advance and the necessary checks made before the patient attends the unit.
Relevant scanning should be available and reviewed as required by the endoscopist supported, if necessary, by a specialist radiologist. In the individual survey, 16% of ERCP endoscopists felt that they were not adequately supported by specialist gastro-intestinal (GI) radiologist. It is important that there is access to specialist radiology when considering interventions such as biliary stenting and where this is not available measures must be put in place to rectify this, perhaps looking at a networked solution. When a patient is transferred from another unit it is essential that the imaging is made available to the receiving unit. In circumstances of specialist (eg, paediatric) procedures the required on-site support from allied specialties should be alerted that the case is going ahead.
Statement13. Careful attention to preprocedure preparation should include reviewing radiology, checking blood results, medication, cardiac devices, ensuring the patient is hydrated with intravenous fluids and that the necessary support specialties are notified in advance of the procedure. Specialist radiological support should be available to review imaging where required.
Safer surgical checklistsFollowing the implementation of the WHO Safe Surgical Checklist in 2009, National Safety Standards for Invasive Procedures (NatSSIPs) were introduced across the NHS 2015 and updated in 2023 (NatSSIPs2).26 These latest standards document 8 steps that should be taken for invasive procedures, though steps can be amended and procedures that are performed in a dedicated area are suited to a specialty-specific checklist that is proportionate to the risks and processes in that area. The standards state that, based on the risk within that specialty, the type of anaesthesia and procedure (major vs minor procedure), particular checks may be more or less applicable. Nonetheless, certain steps such as team brief, sign-in, time-out, implant checks and sign-out must always occur though in some cases sign-in and time-out can occur together and debrief may not always be required.
In the UK survey, a team brief involving all members of the team always occurred in 74% of units but only sometimes or never in 22% and 4%, respectively. Regarding the sign-in/time-out, most units combine this but 59% use a standard endoscopy checklist that may miss elements that are specifically relevant to ERCP such as pregnancy and blood test checks. 38% use an adapted preprocedure list while 3% either only sometimes or never perform a preprocedure checklist.
In the ESGE position statement on performance measures for the team-centred approach to advanced endoscopic procedures, it is recommended that a WHO abbreviated/adapted checklist should be documented prior to the procedure.27 They argue that most generic endoscopy checklists would not adequately address the idiosyncrasies of advanced procedures, and checklists need to be nuanced or individualised to the clinical circumstance, for example, to check anticoagulation, requirement for antibiotic prophylaxis or antiplatelet medication and advanced equipment checks.
ERCP is a service in which implants (stents) are frequently used. The correct choice (length, covered, uncovered) and ensuring it is in date is paramount and errors occur where this is not checked.
Furthermore, ERCP is an environment in which complications occur, which, as well as being harmful for patients, can be stressful for staff. Postprocedural debriefs should be encouraged, particularly in the event of a significant adverse event but can have positive impacts on team morale if used after successful procedures too.27 A summary of key components of safer surgical checklists relevant to ERCP is included in table 3.
Table 3Safer surgical checklist components relevant to an ERCP list
Statements14. Before any ERCP list, a full team briefing should occur. This should involve all members of the team (endoscopist(s), nursing team, radiographer and anaesthetist) in which cases are reviewed, potential difficulties highlighted and potential equipment (including endoscope) requirements reviewed.
15. Before each ERCP procedure, a minimum of a sign-in and time-out should occur that should include all of the basic endoscopy requirements (eg, identification, consent) but also components specific to ERCP (eg, clotting, pregnancy checks).
16. Whenever a stent is to be used, there should be a further time-out in which it is checked that the correct stent is being used and is in date.
17. Debriefs should occur at the end of lists and should focus on good practice and discussion about adverse events.
Staff well-being and teamworkIn the individual survey, 97% of ERCP endoscopists reported that they felt confident performing ERCP most of the time and 95% enjoyed their lists most of the time, with only a small number reporting dissatisfaction or lack of confidence. However, ERCP can be a tiring and stressful environment to work in. In the stakeholder group interviews, nurses described the environment as ‘challenging’, ‘complex’, ‘intense’ and ‘difficult’ and the culture of the room was often described as not being either inclusive, calm or supportive.
Fatigue is a significant element of ERCP practice given the need to concentrate for extended periods of time, standing upright and wearing lead gowns. Lists should be booked taking into consideration skill mix and complexity such that late finishes should be the exception, not the rule. Late finishes should be monitored and if they are frequent, the reasons behind this should be investigated and rectified. Steps must be taken to minimise fatigue, including the provision of lightweight lead gowns. Breaks should be taken, particularly after a lengthy case. There should be easy access by an accessible phone to support staff if a procedure is proving lengthy or difficult. Drinks to maintain hydration should be available. Staff changes should be minimised during a list but should be encouraged between morning and afternoon sessions. Where staff changes do occur during a list, a repeat briefing may be necessary.
Communication and teamwork, situation awareness and leadership are all key elements of endoscopic non-technical skills (ENTS) that will lead to better outcomes from procedures.28 There is an acknowledged shortfall of nurses who are keen to enter the ERCP environment. Attempts to enhance this environment should be encouraged to ensure that ERCP lists can be staffed by well-trained and enthusiastic nursing staff. A focus on teamwork in ERCP is particularly relevant and should be encouraged through training processes that include all members of the ERCP service team.29 An acceptance of the risks of ERCP enshrined in a learning culture accompanied by well-constructed team briefs and debriefs will also benefit the well-being of the team and procedure outcomes.27
Statement18. A focus on teamwork to foster a welcoming, just and learning culture in the ERCP room should be developed in all ERCP teams. Lists should be booked to avoid fatigue, with the provision of breaks and access to support staff.
Avoidance and management of complicationsPancreatitis is the most common complication of ERCP. Risk factors for pancreatitis and other complications have been identified in many studies and should be evaluated for all patients.7 Such risk factors should be taken into consideration in the process of case selection and the consent discussion, as identified in the recent Coroner’s inquest.18
Measures to reduce pancreatitis include use of rectal NSAIDs, placement of pancreatic ductal stents and aggressive intravenous fluid regimes. In the Individual survey, 25% of endoscopists always and 51% usually follow standard ESGE guidance on placement of pancreatic stents in the circumstance of inadvertent guidewire insertion into the pancreatic duct and only 3% of units have a written policy in this respect.7 44% of units have a written policy regarding rectal NSAID use whereas the remainder rely on individual practice. Adherence to international guidelines in relation to reducing the risk of pancreatitis should be mandatory and enshrined in written unit standard policies.
Early recognition and management of complications such as perforation or haemorrhage will lead to better outcomes. Endoscopists should be observant for the features of perforation during a procedure including worsening patient discomfort and be alert to free air on the X-ray image. While the absence of free gas does not exclude a perforation, its presence confirms it. While the acquisition of ERCP images varies significantly between practitioners, endoscopists should always scrutinise the final image to ensure that there is no evidence of a complication.
Pathways for managing suspected adverse events should be clearly identified and documented, including measures to access on-call teams, support for the deteriorating patient and emergency CT scans or IR.27 A culture of early recognition and escalation of complications to the endoscopist from recovery nurses should be encouraged and a process of notification of complications established so they can be reviewed in morbidity and mortality (M&M) meetings. Duty of Candour policies should be followed in relation to ERCP complications and enshrined in the written unit SOP.
Statement19. Unit policies for prevention and recognition of complications from ERCP should be enshrined in the written unit SOP. A culture of early recognition of complications during and after the procedure should be encouraged and enhanced through team-based training.
PostprocedureRecoveryThe purpose of the immediate postprocedure period is to ensure safe and timely recovery from administered sedation or anaesthetic, early detection and management of adverse events should they occur and the provision of information after the procedure before discharge.
Recovery from sedation or anaesthesia is the same for ERCP as any endoscopic procedure, though patients are often more comorbid and may have had a longer procedure requiring higher doses of sedation so require careful monitoring in recovery.
In 44% of units, ERCPs are performed in radiology. In circumstances where procedures are being performed away from the main endoscopy unit patients should have access to the same minimum standard recovery facilities and monitoring as all patients who have had an ERCP before discharge or return to the ward. It is also important that patient recovery should occur outside of the endoscopy room to allow satisfactory patient flow during the list.
ERCP recovery should be sufficiently staffed by nurses trained and experienced in monitoring and managing patients for cardiovascular complications following sedation and they should have access to appropriate medical support if adverse events occur.
Units should adopt a policy of monitoring patients carefully in the post-ERCP period with nurses trained in recognising the symptoms of pancreatitis or other ERCP-related adverse events such as perforation. Development of pain that does not settle with simple analgesia should prompt urgent review by a clinician experienced in managing patients post-ERCP and usually admission into hospital. Although ESGE suggests testing serum amylase and/or lipase as a means of triaging safe discharge, in practice this is difficult to implement and is, therefore, not encouraged.7 Patients should have access to blood tests or urgent imaging with CT scanning where there is a suspicion of perforation.
There is no universally accepted time duration for monitoring patients before discharge. Extended monitoring will result in inappropriate delays to discharge and a reduction in the proportion of cases being performed as day cases, whereas short monitoring periods will result in delayed diagnosis for patients discharged before the symptoms of an adverse event have developed. Most patients with pancreatitis will develop symptoms within a few hours so patients should be monitored for a minimum of 4 hours after the procedure. It may be clinically appropriate in selected low-risk patients to be discharged sooner, but not less than 2 hours after a procedure. Such patients should receive adequate safety netting advice and be reviewed by an ERCP endoscopist before discharge. Circumstances in which this is expected to occur should be noted in the unit SOP. However, units should monitor and audit all readmissions after ERCP.
Statement
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