Statement

1. Endoscopy units that offer ERCP should have a dedicated written policy covering administrative processes and common clinical scenarios.

Preprocedure

Statement

2. 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.

Statements

3. 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.

Statements

6. 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.

Statements

10. 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.

Procedure

Statement

13. 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.

Statements

14. 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.

Statement

18. 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.

Statement

19. 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.

Postprocedure

Statement

20. 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.

Statement

21. 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.

Statement

22. 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.

Nursing

Successful therapeutic endoscopy is a consequence of teamwork.27 This is nowhere more relevant than in ERCP due to the wide range of equipment that is in use, sometimes lengthy procedures and the risk of complications. In the stakeholder interviews, ERCP nursing was seen as a complex skill to learn with a high level of knowledge required. Some reported the ERCP environment as challenging with a room culture governed by the endoscopist whereas valuing the skill of the ERCP nursing workforce garners a more positive working environment favouring better outcomes and encouraging nurses to advance their skills and undertake additional training to support ERCP.

For the procedure, the ERCP team includes the endoscopist, radiographer and nursing assistants who support with patient care and equipment preparation. However, the role of nursing in ERCP is far broader than this. In the room, an experienced ERCP nurse may anticipate next steps and assist with guidewire manipulation, stent delivery and can offer advice and support for the endoscopist and remainder of the team during the procedure.

ERCP nursing and leading an ERCP room requires a specific skillset that should be recognised as an integral part of the procedure and supported by the wider team. In the organisational survey, 47% of units required a formal assessment of ERCP-specific competency before they could lead a room whereas in 33% of units, ERCP competencies are not defined and there is no specific sign-off process. In view of the complexity of the procedures and the opportunity for error, competencies should be defined and demonstrated before a nurse can lead a room.

In addition, it is important that specialist ERCP nurses should demonstrate and, where necessary, receive training in leadership skills and ENTS as well as in indications for ERCP, pancreaticobiliary anatomy and physiology, equipment and ERCP complications.28 Nurses should be encouraged and empowered to offer opinions and advice and be part of shared decision-making in all aspects of the procedure including prominent roles in preprocedure and postprocedure briefings and procedure checklists.

Care of the ERCP patient is not limited to the procedure room and there are several key roles outside of the ERCP room that are vital to support positive outcomes. Senior nurses and supporting staff assist with stock management and list preparation to ensure essential equipment is available and patients are prioritised and listed appropriately. Preassessment is essential to ensure that patients are adequately prepared and informed prior to their procedure. Currently, this occurs in only 64% of units whereas this should be universal. Senior ERCP nurses and unit managers should ensure that there is appropriate training in postprocedural care, including early recognition of complications and deteriorating patients. Finally, senior ERCP nurses should have key roles in investigating adverse events and in clinical safety and governance, contribute to MDT discussions (both at a local and network level) as well as supporting training for other nurses within the unit and the wider network.

There is an increased role for advanced clinical practitioners (ACP) who can assist with patient assessment on the ward and counselling before and after the procedure. The latest BSG guidance on consent states ‘For high-risk urgent procedures patients should have access to an appropriately trained individual who can discuss the risks and alternatives to the patient on an individualised basis before they attend the endoscopy department for the procedure.’16 This role can be successfully fulfilled by an appropriately trained ACP with a specialist interest in gastroenterology or hepatology. Currently, a specialist nurse routinely reviews patients on the ward prior to the procedure in only 16% of units and expansion of this role should be encouraged.

As noted above, there is currently no recognised curriculum or framework for training in ERCP consent. Nonetheless, consent for ERCP should involve a collaborative approach such that all ERCP and endoscopy nursing staff should be encouraged to participate in providing information and contribute to the consent process to the level of their ability and training.

The organisational survey demonstrated that the vast majority of units use three (76%) or more nurses to support an ERCP list, but that 6% of units use only two nurses. However, stakeholder interviews reported that there was a shortage of trained ERCP nurses and sometimes lists were understaffed. While the number of nurses required to support an ERCP list will vary, in the absence of anaesthetic support, the minimum should include one for patient care (head end) and two for equipment preparation and endoscopist assistance. If the list is performed on a remote site the number may be greater whereas if the procedure is supported by an anaesthetist and operating department practitioner (ODP) the number may be reduced.

While it is the case that an ERCP list should have appropriately trained and qualified nursing presence, it is recognised that the technical and non-technical skills required to support an ERCP list can be acquired by other allied health practitioners, for example, ODPs, healthcare assistants, assistant practitioners and nursing assistants and such individuals can support or lead ERCP lists where they have acquired and demonstrated the appropriate competencies in line with local governance protocols.

The number of nurses that a unit needs to train will vary. A balance has to be accepted between ensuring that there are sufficient trained staff to support regular lists allowing for absences, breaks and avoiding all-day lists on the one hand, while on the other, ensuring that trained nurses spend sufficient time in ERCP rooms to maintain their skills. In doing so, lead nurses, units and networks should ensure that nurses adopting a specialist ERCP role are adequately trained and signed off in defined competencies. Cross-departmental training and experience across an ERCP network is encouraged to support high-level practice even in lower volume units and facilitate movement of staff between units if required. Training ERCP nurses in these specialist techniques requires that staff should be supported to attend training courses both in terms of time and finance and the creation of more specialist courses that support nurse training in ERCP should be a priority.

Statements

23. Each unit should have a list of nurses who have 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 one 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.

Management

Running an ERCP service is complex. Patients come from diverse sources, many are very acute and follow-up requirements are important. Services require support from other departments such as radiology and anaesthetics. Processes to ensure follow-up procedures and stent removals occur on time are essential but variable in the UK.3 Given the acuity of ERCP procedures,6 waiting times should be monitored and actioned and there should be notice when staffing levels mean list numbers fall below an accepted level, for example, due to annual leave, for which there should be a defined action plan. In this circumstance, options for movement of patients within a network to maximise capacity may need to be considered. The governance processes for ERCP are time-consuming but essential. Likewise, the acknowledged need for MDTs requires support at a managerial and clerical level. For these reasons, it is recommended that an ERCP service is supported by a triumvirate of lead endoscopist, nurse and manager who have dedicated time to enhance the service.

Statements

32. 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.

The patient

ERCP may be a daunting prospect for many patients. They are frequently unwell and may be on opioid or other medication that impairs cognition, which must be considered as part of the capacity assessment for consent. Ideally, as a result, family members or friends should be involved in these discussions.

A patient attending for ERCP may not be at their best due to illness, fear and cognitive overload. ERCP is often required urgently but time should still be made for detailed discussions and information provision. In the UK, most ERCP continues to be performed under conscious sedation, yet there are critical steps in an ERCP that require completion for a safe outcome. This could potentially lead to a prolonged procedure during which the effect of sedation diminishes. These factors may result in an uncomfortable, agitated or at worst a non-compliant patient. Such circumstances should prompt early abandonment of the procedure, as soon as it is safe to do so, with early access to DS/GA to support comfortable and safe completion of the procedure objectives. In order to meet the needs of such patients, networks will need to look to expand the availability of DS/GA lists.

Units and all members of the wider ERCP team must recognise and accommodate these patient factors. A fully informed and reassured patient will likely be more compliant with the procedure resulting in a better experience for both the patient and team alike and in all probability a better clinical outcome. In the context of the procedure, this will be achieved by considering the patient as part of the team.

Further benefits will be achieved through involving patients to review information platforms, which should consider and explain all steps of the procedure, particularly, the process and use of conscious sedation if it is to be used. Patient feedback should be sought for all elements of the service and this should be evaluated in departmental governance meetings. While there are validated Patient Reported Experience Measures for endoscopy generally, these should be developed and validated for ERCP specifically to facilitate this process.30

Statement

35. Feedback from patients who have had ERCP should be sought and fed back to unit and network governance meetings.

Supporting specialties

As a purely therapeutic procedure, high-quality ERCP is predicated on timely imaging and close collaboration with interested radiologists. A radiologist will be a key member of the ERCP MDT and radiology expertise should be readily available to review images and discuss cases within the MDT setting and on an ad hoc basis. The majority (87%) of respondents in the individual survey felt adequately supported by specialist GI radiologists. However, lack of trained specialist radiologists, access to image review and reporting and radiologists having job planned time to be available to support ERCP were among the top five most commonly suggested improvements to specialist radiology support. The most common suggested improvements were holding regular meetings with specialist radiology (16%) and the facility to perform combined procedures with IR (15%).

A significant proportion of patients undergoing ERCP are on surgical pathways leading to cholecystectomy or pancreaticobiliary surgery though alternative surgical management strategies such as laparoscopic CBD exploration may be appropriate for some patients under consideration of ERCP who have an in situ gallbladder. Optimum management of complex cases occurs at an intersection between surgical, interventional radiological and endoscopic techniques, which are under continuous development and refinement. The best patient management requires close collaboration between diagnostic radiology, endoscopy, surgery and IR to ensure a personalised approach with the selection of the best management strategy for that individual. Thus, radiological and surgical input into the ERCP MDT is required.

Adverse events due to ERCP may uncommonly require surgery or IR and urgent or failed procedures may require percutaneous biliary drainage (PTBD). A clear pathway to access 7-day PTBD either on-site or within the network is an essential attribute of an ERCP service. In the survey 55% of units had 7-day access to PTBD either in their own hospital or via a formal network arrangement, 12% relied on informal arrangements and 33% of units reported not having access to PTBD 7 days a week. Therefore, a close and collaborative relationship between the ERCP, surgical and radiological teams is crucial to the delivery of a high-quality safe ERCP service. Onsite access to acute surgical or IR expertise in the event of adverse events is preferable but where this is not consistently available, it should be noted in the departmental SOP and a clearly defined pathway to acute surgical and radiological expertise within the network should be described.

Anaesthetic engagement and support are important for the development and delivery of elective DS/GA lists and also in emergency or clinically unstable cases. While not every unit will have access to GA/DS there should still be access to anaesthetic support for acute or unstable cases. The latter may often be carried out in theatre as patients will usually be very unwell and unstable. Although rare events, all units should have clear and agreed pathways for these circumstances.

Statements

36. 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 development

CPD is central to providing high-quality, safe patient care. The GMC’s updated guidance on Good Medical Practice states that: ‘You must take steps to monitor, maintain, develop, and improve your performance and the quality of your work, including taking part in systems of quality assurance and quality improvement to promote patient safety across the whole scope of your practice’ ‘and, regarding CPD (Domain 1, point 13c), this includes ‘regularly taking part in training and/or continuing professional development.’ 31

From the BSG survey, it is clear that some clinicians struggle to achieve regular or adequate CPD specifically related to ERCP: 38% last undertook online CPD related to ERCP more than 12 months previously while over half of respondents (58%) had not attended any face-to-face ERCP CPD activities in the last 12 months. Half of respondents (53%) had no job-planned time for ERCP-related CPD and a similar percentage felt they had inadequate time allocated to this activity in their job plan. 79% of endoscopists surveyed felt they would like 1–2 hours per week of ERCP-related CPD and many suggestions for improving access to CPD were put forward, including dedicated CPD time which was supported by managers (suggested by 28%), more online training courses (22%) and more in-person training courses (20%). Other possibilities included peer-to-peer support, visits to tertiary centres and specific ERCP-related conferences or courses.

One-third of respondents suggested formalised governance and audit review would be helpful and, in the related stakeholder interviews, this was also highlighted as central to practitioner development, particularly for more junior endoscopists, as it provided opportunities to reflect, learn and improve.

Statement

40. 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.

Clinical governance and patient safety

Clinical governance in the NHS can be described as ‘system through which NHS organisations are accountable for continuously improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish’. The GMC ‘Good Medical Practice Guide 2024’ also mandates that all registered medical practitioners participate in quality improvement to promote patient safety.31

ERCP is a high-risk endoscopic procedure. It is, therefore, crucial that individual clinicians, departments and the wider organisation ensure that appropriate clinical governance arrangements are in place to oversee and monitor safety, quality and patient experience. Individuals and teams should be confident that their ERCP practice is safe and of high quality and compares well when benchmarked against other practitioners, other units and published KPI or auditable outcomes for ERCP. The 2014 BSG document ‘The Way Forward’ outlined a number of clinical KPIs relevant to individual practitioners and units that are relevant today and should remain the minimum standard of clinical practice.2

The organisational survey showed that in many units good clinical governance arrangements are in place. 90% of units, for example, reported collation of routine quality assurance information. However, this means that 10% of units do not collate this information. It also showed that only 60% of units carry out planned patient record reviews to assess M&M. The main barriers to learning from clinical practice were identified as digital records not supporting easy audit reporting, lack of administrative support, lack of clinician time to carry out or oversee the work and lack of formal governance processes. Audit was particularly difficult for referral centres, where subsequent admissions happen in other units. 20% of units do not carry out any M&M reviews for patients referred from other units.

In stakeholder interviews, ERCP MDT meetings taking place prior to the procedure were seen as a useful tool for governance and discussion of complex cases, as well as best practice in patient selection. Provision for an ERCP MDT is, however, often lacking. Barriers to this were cited as lack of scheduled time in job plans and isolation of endoscopists performing ERCP from other ERCP colleagues locally or in wider networks.

In order to implement these changes and ensure compliance with KPIs and clinical governance standards, units should have a nominated clinical lead for their ERCP service, with adequate job planned time to facilitate this work. In most cases, it is likely this will be an ERCP endoscopist, though in smaller units this could be the endoscopy lead or another appropriate clinician who takes overall responsibility for the ERCP service.

All units should contribute data to the National Endoscopy Database (NED), which in turn will provide some clinical audit data. However, NED is unable to provide outcomes, complications or mortality data, which currently need to be collated manually. Linkage to Hospital Episode Statistics (HES) is desirable but not routinely available. Currently, such data are collated by clinicians or fellows. The ability to routinely collate such outcomes data for audit and governance should be developed and job planned within units, ideally with administrative team support. Networks and units should describe how and who collects these data within their SOP.

Further consideration for the safety and governance arrangements should be given to units in private or independent hospitals where different challenges may be met. The survey identified 8 (5%) private hospitals providing ERCP. For endoscopists working in private hospitals, whole practice data can be considered if they also work in the NHS, but there may be significant difficulties in terms of ensuring adequate patient numbers, obtaining/maintaining nursing skills and providing similar access to benign/malignant MDTs. It is essential in this respect that the entire ERCP team have regular access to procedures and that any shortfalls in procedure numbers, training and MDT access are addressed by the hospital with compelling evidence available that this has been achieved.32

Key performance indicators

Those KPIs adopted from the 2014 Standards Framework document that have not been repeated elsewhere in this document are listed in tables 4 and 5. Units and networks should have a process for monitoring individual KPIs as listed in the tables. The priority is high-quality safe practice evidenced by clinical outcomes. If individual performance levels are not achieved, or if performance or safety concerns are raised in other ways, there should be an agreed process for managing this in accordance with national guidance.33 34

10 years have elapsed since the standards framework was published. It is now expected that, with respect to caseload numbers, individuals and units should meet the ‘achievable’ levels of 100 and 200 cases per annum, respectively, and that these should now be the auditable standard. While there is a lack of a clear-cut evidence base to support these precise thresholds, higher individual and unit procedure numbers have been associated with better patient-related outcomes both in malignant and benign disease, reduced adverse events and greater adherence to clinical guidelines.35–40 The priority in stressing these numbers is in promoting equal access for all patients to high standards of care.

Mandating higher numbers encourages the allocation of a sufficient number of lists and job planned time for ERCP and may encourage individuals into subspecialisation with a greater focus on ERCP-specific governance and commitment to CPD. Further, helping individuals and units to achieve higher numbers through shared network working will avoid isolated practice, enhance training and improve the working environment for clinicians. These factors will inevitably benefit patient outcomes.

Although it is recognised that for some individuals these higher numbers may represent a challenge to achieve, the priority remains the clinical outcome for the patient and not the wishes of the clinician. Currently, audit tools are too insensitive to allow detailed analysis of a clinician’s performance so annual numbers remain an essential, though not the only, factor to consider.

Where an individual’s annual number of 100 cases is not being met, and a clinician wishes to continue to provide ERCP this should be recognised and discussed with clinical managers and/or network leads. The discussion should take into consideration other factors including a clinician’s auditable clinical outcomes, transferable skills from other therapeutic work, lifetime experience and the overarching needs of the service. The output from the discussion should describe in writing a process, with achievable timelines, to support that clinician to meet the standards and (rarely) any exemptions that may be appropriate. This should include, where required, additional training, mentoring and facilitating additional lists either in the clinician’s own unit or within the wider network. The priority is a demonstrably safe clinical practice underpinned by adequate procedure numbers.

In stressing higher procedure numbers for units and individuals, there is a strong need to avoid the unintended consequences of driving experienced clinicians away or closing small units serving the needs of remote geographical areas. Networks will need to examine the needs of their population and consider solutions including movement of staff and/or patients between centres. Where exceptions occur, they should be recognised and noted within the network documentation with plans to mitigate the consequences of reduced numbers clearly described.

It should also be stressed that higher annual numbers should not occur at the cost of unnecessary procedures. A high-quality service will have low (and reducing) numbers of repeat procedures and very low numbers of negative cases where anticipated pathology (eg, CBD stones) is not present at the time of the procedure. These two elements of a service should be carefully audited and reported to the network clinical governance meeting.

It is anticipated that as time passes, with improved data acquisition, workforce contraction and the training of pancreaticobiliary-focused specialists the problem related to procedure numbers will diminish, but nonetheless, network and unit leads should not wait for this to occur and need to address these issues as a priority.

Statements

41. 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:

a. 30-day complication and mortality rates.

b. Incidents.

c. Complaints and compliments.

d. Risk management.

e. 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 underperformance 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.

The ERCP unit and procedure room

The responses to the ERCP survey demonstrated that the facilities for ERCP delivery have areas needing improvement, with 50% of individual responders finding them mostly adequate with minor areas of improvement and 14% somewhat inadequate with some key limitations or problems. In addition to this, lack of space in the ERCP room was seen as a barrier to increasing the number of anaesthetist-supported lists for 34% of responders, and lack of space in the recovery room was seen as a barrier to providing facilities for safe recovery and discharge of the patient for 27% of responders.

This was reflected in the stakeholder interviews where there was felt to be a trade-off between the location of the room and the equipment depending on the room being in a dedicated endoscopy unit where patient flow is managed by the endoscopy team as opposed to the radiology department or theatres which have alternative systems of patient management.

Rooms in which ERCP procedures are performed need to be dedicated for use with ionising radiation including the doors and windows with warning lights for when radiation is in use. They also require additional dedicated equipment, storage facilities and dedicated staff for stock management. While this is possible in endoscopy units with a dedicated fluoroscopy room, ERCP is provided in the radiology department in 44% of units and in the operating theatre in 3%. This presents greater challenges as it results in equipment needing to be taken to and from the fluoroscopy rooms in other departments, potentially leading to equipment being unavailable and/or disruptions in patient flow. Furthermore, units built in other departments may not have the appropriate room layout and ergonomics for endoscopic procedures, leading to risks to staff and patients. It should be noted that it is JAG policy that ERCP occurring outside of the endoscopy department should be subject to the same training and governance standards as if it had occurred within the endoscopy department and reports should be recorded on the Endoscopy Reporting Software.33

Recovering patients postprocedure should occur in an area with adequate access to trained staff who can carry out the regular postprocedural checks and are aware of postprocedural complications that may occur after ERCP or associated with sedation.31 There may be a need for more intense monitoring of post-high-risk or anaesthetic procedures, and patients may need one-to-one nursing, which needs to be factored into workforce planning. In addition, a private room should be available for discussions between patients, supported by a friend, relative or caregiver if desired, and a member of the ERCP team to advise on the outcome of the procedure and provide safety netting advice.

Statements

47. 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.

Ergonomics

The use of lead gowns was highlighted as a concern in the stakeholder interviews, with staff reporting musculoskeletal pain associated with prolonged wear. The weight of the lead aprons was seen as a barrier for nurses training to assist in ERCP procedures.

Musculoskeletal injuries are common among ERCP endoscopists.41 Lead aprons used in ERCP can weigh up to 9.1 kg and confer a high static load on the neck, shoulders and back whereas a two-piece apron has a load distribution advantage between the spine and pelvis.42 Lead aprons and neck coverings suitable for the user’s size should be available. They should be lightweight and ideally should be a separate skirt and top. If this is not available, supportive belts to be worn with the aprons should be made available. Removal of lead aprons between procedures should be encouraged, and simple interventions such as a convenient area to hang them should be made available.

Prolonged awkward postures are a risk factor for work-related strain injury, and neutral posture allows optimisation of energy expenditure while reducing force production.42 Thus, the position of the monitor, fluoroscopy screen and procedure table height should be flexible and allow optimisation to the needs of individual endoscopists and nursing staff. The screens should also allow adequate views by the ERCP nurses and radiographers. Nurses should be provided with height adjustable stools with sufficient space to allow them to focus on the patient as well as be able to access monitoring equipment and their paperwork. In addition to this, there needs to be space in the room for trolleys, equipment preparation and to allow easy access to commonly used equipment and intraprocedural medication such as sedation, reversal agents and antispasmodics. Consideration of ergonomic principles may have a benefit in reducing the risk of work-related strain and radiation exposure.43 Furthermore, trip hazards including trailing cables should be well covered and marked out.

Statements

49. 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 equipment and radiation protection

The provision of fluoroscopy among organisations was equally divided between units that use a mobile C-arm and a static fluoroscopy unit. The fluoroscopy units were rated as mostly adequate with minor areas for improvement by 42% of respondents and as somewhat inadequate with some key limitations or problems by 19%. The stakeholders interviewed felt that mobile C-arms were more likely to be encountered in the endoscopy department screening rooms rather than static fluoroscopy units (fixed C-arms), which were more commonly seen in the radiology department. Concerns were raised about potentially poorer imaging quality with mobile C-arms.

Mobile C-arms give out less energy and are designed to be used in rooms that may not necessarily be lead-lined and thus have lower imaging quality. Wherever possible, ERCP should be carried out in a dedicated fluoroscopy room with a fixed C-arm. This is especially important in centres that perform Schutz grades 3 and 4, which will likely require a higher imaging definition to allow for the adequate assessment and management of more complex pancreaticobiliary pathology. Complex (grades 3 and 4) ERCP should be avoided where imaging quality is inadequate with a mobile C-arm.

Radiation doses were not recorded for individual procedures in 26% of organisations, and 17% did not monitor radiation exposure to ERCP endoscopists and nursing staff. Dosimeters are a mandatory legal requirement for all staff, including temporary staff within the department and their use should be implemented and monitored.

Almost half of organisations do not provide a radiation safety course. These are not in line with Ionising Radiation Medical Exposure Regulations (IRMER) regulations, where the onus of monitoring radiation exposure to staff falls on organisations with a recommendation to provide a regulation safety course to all staff who work with ionising radiation. IRMER courses are available for non-radiologists and are a mandatory safety requirement for staff working with ionising radiation.44 45 Educating staff on ionising radiation not only improves their adherence to safety measures but also increases their understanding of how they can minimise radiation exposure in the room by simple measures such as where they stand in relation to the fluoroscopy unit and reducing fluoroscopy time and should, therefore, be mandatory for all ERCP endoscopists on a regular basis.46

PPE (personal protective equipment) for staff working with ionising radiation shielding measures include lead aprons, thyroid shields and eye protection with lead glasses.42 47 Ocular exposure is similar to thyroid exposure during ERCP and can lead to cataracts and other ocular diseases such as macular degeneration. However, lead glasses are often not available in ERCP rooms or advocated as part of routine radiation shielding.48 In addition, units should be able to provide acrylic and protective lead shields to reduce exposure to scattered radiation.46 49 The PPE provided should meet the requirements of the user, and if required, personal assessments should be carried out to ensure that the legal requirements for protection against radiation-related illness are met.

There is a gender discrepancy in the ERCP workforce, with only 4% of ERCP endoscopists in the UK being female. Additional concerns were raised in the stakeholder interviews, specifically in relation to female staff. These include adequate cover of breast tissue and continued working with radiation while pregnant. Axillary covers should be considered to decrease radiation exposure in breast tissue.50 Consideration should be made for more frequent dosimeter checks for pregnant women. Pregnant staff should have risk assessments performed if they will be participating in ERCP, with reassurance that the actual dose of radiation to the pregnant woman and fetus would be well below the recommended limits.51

Statements

51. 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 acquisitions

There is no guidance covering standard image acquisition for ERCP, which is reflected in the variation in responses within the survey. In regard to X-ray acquisitions in cases for stone extraction, control films (with no contrast injected) were taken by 55% of respondents, an underfilled contrast cholangiogram by 71% and a cholangiogram with full opacification of the CBD/common hepatic duct/intrahepatic ducts in 49%. After stone extraction, 92% of respondents performed an X-ray acquisition with the extraction balloon inflated at the papilla with contrast above, 27% following the removal of all accessories with duodenoscope in situ and 45% following the removal of the duodenoscope.

The fluoroscopy images captured during ERCP should narrate the events that occurred during the ERCP with the ability to allow a detailed retrospective review of each case. This is essential to facilitate further clinical decision-making, especially if there is a complication from the procedure or it is incomplete. Furthermore, in the event of a medicolegal claim, stored images provide an essential reference point for reviewing the procedure.

Thus, standard images in every ERCP should include, at a minimum, a control image (no contrast or accessories), a cholangiogram and a final full abdominal exposure at the completion of the procedure. Further images should be taken that demonstrate any pathology that is encountered and significant steps taken during the procedure (including inadvertent events such as pancreatic duct cannulation). In the case of stone disease, a high-quality cholangiogram should be taken at the end of the procedure demonstrating, as far as possible, duct clearance where it has occurred. In addition, if the fluoroscopy machine is capable of capturing screening cine loops, then these should also be saved as they minimise the need for additional radiation.

Statements

55. 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 accessories

Two-thirds of the duodenoscopes being used by organisations are less than 5 years old. The endoscopists rated the duodenoscopes as mostly adequate with minor areas for improvement at 54% and somewhat inadequate with some key limitations at 7%. Perceived advantages of newer endoscopes include disposable caps which can potentially reduce duodenoscope-associated infections.52 Despite these advances, reducing human error in reprocessing remains a key factor in reducing contamination.53 Newer duodenoscopes with disposable caps or single-use duodenoscopes may be associated with additional device-associated adverse events.54 The role of single use duodenoscopes is yet to be clearly defined in clinical practice and needs to take into consideration the handling characteristics, costs and environmental impact.55 56

There is a complexity involved in the standard equipment used in any ERCP. It is important to ensure that stock levels are sufficient to meet the demands of frequent lists and that there are systems to facilitate prompt replacement of equipment to ensure that key items are always available on demand. Dedicated systems for stock management are thus required. A standard ERCP uses a minimum of a guidewire, cannulation device and contrast and the number of additional equipment consumables increases with procedure complexity. Focusing on biliary strictures the length, diameter and type of stents can be vastly different between cases with a similar underlying disease process. In addition to this a full armament of equipment is required to allow management of unexpected findings or intraprocedural complications.

There needs to be an understanding of how to set up and operate the equipment and the ability to troubleshoot when needed by the endoscopists and nursing staff. Although some equipment is used more frequently, others such as baskets or lithotripters may be used less frequently so there is an onus for continued training and refreshing the skills of the nursing workforce.

Statements

57. There should be a sufficient number of duodenoscopes with adequate processing facilities to reduce the risk of duodenoscope-associated infections and to 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

The surveys indicated a desire for more DS/GA availability with 84% of responders feeling that their unit required more access to DS/GA lists and 62% having a preference to perform all ERCP under DS/GA. The main barrier to increasing DS/GA availability was a lack of anaesthetist availability for 86%. Other barriers included cost, monitoring and unavailability of ODPs to support anaesthetists.

Across organisations, there exists a provision of a DS/GA endoscopy service with 26% having regular lists each week, and 58% having access on an ad hoc basis. 16% of organisations have access to two or more regular DS/GA lists per week; of these, 34% are exclusively for hepato–pancreatico–biliary (HPB) endoscopy. Criteria for patient allocation to a DS/GA list include previous patient intolerance (93%), anticipated sedation risk to the patient (57%) and anticipated complexity of the procedure (53%).

The BSG sedation guidelines state that the sedation dose should be tailored to the procedural complexity, patient factors, procedure type and duration. Specifically regarding ERCP, the use of DS/GA is suggested for complex ERCP (Schutz grades 3 and 4) and combined EUS and ERCP procedures.57

Younger patients may have reduced tolerance to ERCP under conscious sedation, resulting in more unsuccessful or incomplete procedures, so consideration may need to be given to increasing access to DS/GA for these patients.58 59 Patients who are critically ill and need emergency ERCP should have an anaesthetic review and be performed on an anaesthetic-supported list.

Some patients who underwent ERCP under conscious sedation who were interviewed as part of the stakeholder groups found the experience of ERCP traumatic even when they had a positive outcome from the procedure and most would have preferred to have received a GA. This is clearly an area where more work is needed to improve the patient experience.

Although DS/GA can reduce list capacity, a quality service would meet the minimum standards laid out in the BSG sedation guidelines through increased local or network access to DS/GA lists. It is recognised that lack of availability of DS/GA can result in failed procedures. The joint position statement from the BSG, JAG and Royal College of Anaesthetists in 2019 indicated that the availability of anaesthetist-led DS/GA needed to be expanded in the UK, a situation that has not improved significantly since then.15 This unmet demand will continue to increase as procedure complexity, interventional EUS and combined EUS and ERCP procedures become more common. Work is required by unit and network leaders to improve access to anaesthetist-supported lists in all hospitals to meet this demand, supported by collation of audit data. This should be augmented by national bodies (including the BSG) and patient groups to campaign for greater anaesthetic input to ERCP services.

Statements

60. Access to adequate numbers of DS/GA lists should be improved and made 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.

Statements

62. 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.