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THE FUTURE OF
SERVICE AND TRAINING IN ERCP IN THE UK A STRATEGY
Authors: J.R.B. GREEN & THE UK ERCP STAKEHOLDERS WORKING
PARTY
August 2007
INTRODUCTION

The current place and the future of ERCP (endoscopic retrograde cholangiopancreatography) began to emerge as major issues at national level in 2005.
At that time, the British Society of Gastroenterology (BSG) Endoscopy
Committee considered that attention should be urgently directed towards
ERCP for the following reasons:-
-
the 2004 NCEPOD Report “Scoping our Practice” (1) had been highly
critical of certain aspects of ERCP in the UK, specifically concern
about sedation practice and case selection.
-
the lack of knowledge about the type and incidence of post-ERCP
complications in the UK had in 2005 led the BSG to fund a large
prospective audit into UK ERCP (2).
-
the place of ERCP in diagnosis (as opposed to therapy) , was being
challenged by the increasing availability of endoscopic ultrasound
(EUS) and magnetic resonance cholangiopancreatography (MRCP).
-
the training for ERCP was deemed suboptimal, providing large
numbers of trainees who had undertaken ERCP training with an
insufficient caseload exposure, with few emerging sufficiently
competent to undertake ERCP independently at the time of their
appointment as a consultant.
-
as ERCP had become largely therapeutic, the potential for harm was
greater requiring greater clarity and standards in ERCP training
-
the conversion of ERCP from mandatory to optional training in the
endoscopy curriculum by the Joint Advisory Group (JAG) left an
uncertain direction of travel for the future of ERCP training.

The BSG Endoscopy Committee was asked to address these problems by:-
(a) convening a Stakeholders Group under the chairmanship of Dr Jonathan
Green. The Group was intended to represent all those currently engaged in
performing ERCP in the UK in 2006.
(b) producing a consensus statement of guidance about future service and
training in ERCP in the UK.
(c) reviewing, as a further sub-task, the (then) Endoscopy Committee Quality
and Safety Standards in ERCP – subsequently adopted by the JAG as part
of their Quality and Safety Standards – reported separately to the JAG.
STAKEHOLDER GROUP
The constitution of the Group was as follows:

Jonathan Green
Chairman
Miles Allison
BSG Endoscopy Committee
Howard Smart
BSG Endoscopy Committee
Roland Valori
National Endoscopy Team
Martin Lombard
BSG ERCP Audit
Kel Palmer
Chairman of JAG (till 12/06)
Roger Barton
Chairman of JAG (from 12/06)
Derrick Martin
Royal College of Radiologists
Nick Hayes
AUGIS
Don Menzies
AUGIS
The full group met twice – February 2006 and March 2007 – with a sub-group
meeting in October 2006.

It was recognised that there are many other ‘Stakeholders’ in ERCP (ERCP
endoscopic assistants, interventional radiologists, radiographers, EUS
endoscopists, Healthcare Commissioners and patients) but these groups
were unlikely to influence the initial major strategy and technical decisions
that formed the brief of this Working Party.
EVIDENCE BASE
As with other areas of medicine, much of the evidence on which to base
decisions would be regarded as ‘soft’. Apart from the references quoted, very
little is evidence-based and we therefore rely on snapshot surveys of ERCP
practice, retrospective audits and expert opinion including the Stakeholder Group.
THE FUTURE OF ERCP
(A)
SERVICE
1.
Service Need and Place of ERCP in Service

Surveys and the recent BSG Audit suggest that about 48,000 ERCPs
are performed each year in the UK.

The vast majority of ERCPs are therapeutic and occur after primary
investigations
with
ultrasound,
MRCP
and/or
CT
scanning.
Increasingly, but patchily, pre- ERCP investigation includes EUS.

The Group recognised many other factors that could increase or
decrease the need for ERCP (ageing population, altering incidence of
diseases, alternative therapy techniques etc).

The Group agreed that the likely future incidence of ERCP will be 0.9
per 1,000 per year after balancing all these factors. This amounts of
54,000 ERCPs per year across the UK.

Importantly, the Group did not foresee a reduction in the numbers of
ERCPs performed over time.
2.
Service Provision of ERCP in the Future
Service Structure

Mirroring the JAG (Joint Advisory Group) Quality and Safety
Standards (vide infra), the Group consider that an ERCP service
should perform an absolute minimum of 150 procedures per year and
that there must be more than one trained service deliverer to ensure
continuity of service. This is based on the view that the ERCP team
need to average more than 2 procedures per week to maintain their
collective skills and experience at this unpredictable and demanding
technique.

When an endoscopic service performs less procedures than this the
Group recommends that a network be established with nearby
hospitals to allow these minimum standards to be achieved.

The Group confirm that the management of patients with hepatobiliary
problems involves different specialists with differing skills and many
different techniques. The management of an individual patient should
always be determined by those techniques that best suit the patient’s
clinical problems and not just by either “ownership” by a particular
consultant or by the availability (or otherwise) of an individual
technique in a clinical setting.
Service Delivery – Endoscopists who perform ERCP

From a survey done in 1998 ERCP is performed by medical
Gastroenterologists (75%), upper GI surgeons (13%) and others
(12%) including radiologists (4).

The Group felt that the only criteria for performing ERCP were proper
training, competence and adequate continued experience. All ERCP
endoscopists should have a medical (as opposed to non-medical)
background which would mainly but not exclusively be medical or
surgical gastroenterology or interventional radiology.

Continuing ERCP experience:
-
this is a highly contentious topic but one in which standards do
need to be set.
-
there is as yet no unequivocal evidence relating numbers of
procedures performed per year to surrogates of competence
(cannulation rate, completion rate, etc), except one US study
showing a higher incidence of complication after ERCP by
endoscopists performing less than one sphincterotomy per
week. (2) The Group accept this as evidence that a technique
as complex as ERCP requires an endoscopist to average more
than one procedure per week,
-
a recent BSG survey (unpublished) suggests that 84% of UK
ERCP endoscopists currently perform 75 or more procedures
per year.
-
From the above, the Group recommends that:
(i)
ERCP endoscopists who wish to continue to partake in
the ERCP service should currently aim to achieve a minimum
of 75 cases per year. In future, this minimum standard may be
adjusted with the explicit agreement of all stakeholders.
(ii)
those with less opportunity for achieving these
aspirational numbers should not stop ERCP immediately but
should consider how they might reconfigure their work and job
plans to achieve this in future.

Revalidation / recertification
-
The Group recognises that ERCP endoscopists will in future require
specialist recertification in ERCP.
-
The main tools of recertification in ERCP are unlikely to involve DOPS
(direct observation) as this is potentially difficult to achieve in a timely
and cost effective way in ERCP.
-
Performance measures are therefore likely to dominate the practical
side of recertification in ERCP. These would include continuous audit
of cannulation rate, bile duct drainage rate, major complications,
adverse incidents etc.
ERCP TRAINING
TRAINEES
Aims of Training

At present a CCT in gastroenterology does not include ERCP experience
as a mandatory competency. Due to trainees’ variable exposure to ERCP
experience, CCT currently gives no indication of either exposure to or
level of competence at ERCP.

The Stakeholder Group would wish that at CCT an ERCP trainee would
be competent to perform independent Level 1 ERCP (5). Level 1 includes
selective deep cannulation, biliary sphincterotomy and clearance of bile
duct stones <10mm diameter and placement of stents to relieve common
bile duct obstruction

It is recognised that he / she will usually require a period of additional
clinical supervision / mentoring from an ERCP trainer for a variable period
after CCT to gain further experience at the more difficult (level 2/3)
techniques.
Definition of Training

There is no agreed international definition of competency in ERCP with
specified minimal criteria.

A satisfactory definition of training will inevitably include the clinical triad of
knowledge, skills and attitudes / behaviours amounting to a competency.

The Group therefore suggest the following to be essential elements of training
in ERCP:-
(i)
Knowledge
(a) To include working clinical knowledge of the underlying diseases, the
clinical indications for ERCP and the contra-indications to ERCP.
(b) Knowledge of safe sedation and informed consent. Full knowledge of
the
guidelines
for
managing
specific
risks
e.g.
antibiotics,
anticoagulation etc and identifying high risk patients.
(c) Passing a knowledge assessment e.g the endoscopic section of the
“MRCP Gastro” exit examination
(ii)
Skills
(a) > 80% successful completion of the intended procedure of Level 1
difficulty (5). This will likely require the performance of a minimum of
200 procedures (6)
(b) Post-ERCP complication rate of < 5% (complications defined as
pancreatitis, significant haemorrhage requiring transfusion, perforation
or infection requiring a new prescription of antibiotics).
(c) Assessment of skills will be by:-
formative DOPS records of at least 100 cases during training
-
summative DOPS assessment as per JAG criteria
-
evidence of continued practice with mentoring and recording of
subsequent 100 cases post summative DOPS.
(iii)
Attitudes / Behaviours

In general these will be similar for other types of endoscopy

Assessment will be by multi-source feedback (360’ appraisal)
reports and individual reports from trainers
NUMBERS OF TRAINEES IN ERCP

The UK incidence of ERCP is expected to be 54,000 as outlined in Section 1

Given the forthcoming minimal requirement for a trained ERCP endoscopist
to perform at least 100 ERCP’s per year, this equates to a requirement of 540
trained ERCPists at any one time in the UK to deliver the service.

Given a 20 year span of each trained ERCP endoscopist, approximately 30
new trained ERCPists are needed to enter the service each year to balance
retirements. To generate a minimum of 30 trained ERCP endoscopists per
year, the Group’s views varied as to exactly how many trainees should enter
ERCP training each year but clearly no less than 30 for the whole of the UK
with possibly 10-30% more depending on technological developments, clinical
demand and uneven retirement patterns.
SELECTION OF TRAINEES

If career opportunities within ERCP are to be limited with entry level selection,
it is critical to avoid wastage of both trainees and of training opportunities. As
yet, there is no evidence-based method for reliably selecting those with the
greatest potential of developing ERCP-related skills.

An additional important factor may be that, in future, ERCP training could be
“bundled” with that of other specialised endoscopic techniques such as EUS,
more advanced therapeutic endoscopy such as EMR, ESD etc. The makeup
of the “bundle” would depend on the trainee’s individual training needs. In
these cases, selection would need to include aptitude testing for these
additional skills as well as a clear commitment to a career in which specialist
endoscopy formed a permanent part of their final career trajectory.

Trainee selection can be either by (a) restricting access to and provision of
training – the ‘top down’ regulated / restrictive model or (b) by allowing
trainees to acquire training on their own decision taking their chances at
finding adequate training opportunities and ultimately a permanent post in
which to practise these skills – the free market model.

It is not yet possible to determine which model will predominate. Current
selection methods include –
(a) allocation by Regional Endoscopy Training Directors into a
restricted number of ERCP Training slots.
This requires full co-
operation from all the Regional trainers to be effective
(b) minimum entry standards for would-be such as the Mersey Person
Specification for aspirant ERCP trainees.
This defines minimum
requirements including year of training, courses attended and
competences acquired along with support from trainers and referees
before training can be begun.

None of these selection criteria yet have any compulsion and it may yet be
that trainees will self select and compete for a defined and limited number of
ERCP training slots within each Deanery
MODE OF TRAINING

Current SpR training in ERCP is haphazard and occurs with variable
frequency and reliability.
Training potential is subject to the vagaries of
rotation and to the parallel demands of General (acute) Medicine or Surgery.

The Stakeholders Group recognise that this is both an unsatisfactory and
inadequate way to achieve the aims of training.

An alternative model is suggested, as widely used in some other healthcare
systems.

This involves the concept of a ‘fellowship’ in specialised endoscopy training.
In this, the trainee undertakes a period of either six or twelve months of
intensive training with up to seven or eight sessions of specialist endoscopy
each week. These sessions can of course be in different types of specialist
endoscopy and in different units in a network.

These training periods should be part of conventional postgraduate specialist
training. However, they will not be universal but only applied to those trainees
who propose to undertake specialist endoscopy in their future career.

The Group therefore urge the SAC’s and Training Committees (JRCPTB,
JRCSTB etc) to recommend to PMETB that such intensive periods of training
in specialist endoscopy be integrated into the latter years of specialist training
for suitable trainees.
TRAINERS
Criteria for training ERCP endoscopists to act as trainers were suggested as follows:

Personal experience of and participation in an average of 75 procedures per
year as per non-trainers

Continuous audit certifying complication rates of < 5%; > 90% completion of
intended therapy on level 1 patients.

Attendance as Faculty or Observer at ERCP Training Events outside their
own network as a minimum once every 5 years.

Working in a network with a workload averaging over 150 procedures per
year in order to provide sufficient breadth of experience for trainees.
TRAINING UNITS – within Training Networks
In addition to the minimum standards for service units as defined above, a Training
Network must provide trainees with experience training in units which provide:
Higher caseload > 200 procedures per year to guarantee case mix

Guaranteed experience of cases above level 1 degree of difficulty to ensure
adequate experience of more difficult procedures to trainees of all levels of
experience and competence
NEXT STEPS

This report will be submitted to the JAG. In parallel, it will be submitted to all
the stakeholder organisations.

Where there are choices, the JAG will make the final decision.

After all agreed amendments, this report will be adopted by the JAG.

This report will then appear on the JAG website and will be the JAG guidance
for the future direction of ERCP in the UK.

Any recommendations within the direct remit of the JAG will be implemented
as stated

The s.a.c’s. in gastroenterology, surgery and radiology will be asked to
recommend the conclusions to the Training Boards (JRCPTB, JRCSTB etc)
and through these bodies to PMETB.

As the recommendations of the final report will have the imprimatur of the
JAG, they will commend the report to PMETB directly. In particular, they will
recommend that the 6 or 12 month ‘fellowship’ training periods be included
(and thus funded) as a standard option in SpR (ST) training posts in the later
years of Specialist Training for appropriate trainees.

The JAG will need to recognise that the particular problems and concerns of
training and service provision of all specialist endoscopy (ERCP, EUS,
EMR/ESD and other advanced therapies) differ significantly from those of
‘volume’ endoscopy. Because of this, the considerations specific to specialist
endoscopy need to continue to be represented and monitored at the highest
level within the JAG – and mechanisms to achieve this will need to be
devised.
JAG QUALITY AND SAFETY STANDARDS FOR ERCP – August 2007
ERCP
Structure


Process




Staffing


Quality
standards



Auditable
outcomes


Quality
An Endoscopy Unit caseload of at
least 150 procedures per year
Sufficient accessories to perform
all standard therapeutic
manoeuvres at the time of the
procedure


Safety
Haemostasis equipment to control
unexpected bleeding
Availability of emergency lithotriptor
Pre-ERCP assessment of all
patients by appropriately trained
staff
Indications for ERCP and place of
ERCP in the management
pathway to be agreed locally
Evidence of consultant
involvement in every decision to
perform (c/f request) ERCP
Contemporaneous report in notes
of all patients
An agreed minimum workload
(procedure type/volume) per
endoscopist
A minimum of 2 ERCP-trained
endoscopists within a centre or
local network, to enable
continuous service provision


For each case, a minimum of 3
endoscopy assistants with appropriate
competences
>90% of ERCPs intended as
therapeutic
Completion of the intended
therapeutic procedure (eg
decompression of dilated and/or
obstructed biliary system) at
initial ERCP in at least 80% of
cases
Following failed initial ERCP,
decompression of obstructed
biliary systems within 5 working
days in a stable patient, or within
24hr in an unstable patient (e.g.
severe cholangitis)
Number of procedures performed
by each operator
Success in cannulating desired
duct and in performance of
intended therapeutic procedure

Sphincterotomy bleeding requiring
transfusion < 2%
Perforation rate <2%
Clinically symptomatic pancreatitis
< 5%
Procedure related mortality <1%
Continued appropriate antibiotic
treatment when obstruction unrelieved
by ERCP in 100% of cases








Formal record of adverse incidents e.g.
significant complications and mortality
Compliance with local radiological
protection guidelines
Prophylactic antibiotics given according
to local guidelines
Frequency of post-procedure clinical
pancreatitis
Please refer back to “General quality
and safety indicators”
References
1) Scoping our Practice - NCEPOD Report 2004
2) Are we meeting the standards set for endoscopy? Results of a large scale
prospective survey of endoscopic retrograde cholangio-pancreatography.
Williams EJ, Taylor S, Fairclough P, Hamlyn A, Logan RF, Martin D, Riley SA,
Veitch P, Wilkinson M, Lombard M. Gut 2007; 56: 821-9
3) Freeman ML, Nelson DB, Sherman S, Haber G, Herman ME, Dorsher PJ,
Moore JP, Fennerty MB, Ryan ME, Shaw MJ, Lande JD, Pheley AM.
Complications of endoscopic biliary sphincterotomy. N Engl J Med 1996;
335(13): 909-16
4) Allison MC, Ramanaden DN, Fouweather MG, Davis DK, Colin-Jones DG.
Provision of ERCP services and training in the United Kingdom. Endoscopy
2000; 32(9): 693-9
5) Schutz SM, Abbott RM. Grading of ERCP’s by degree of difficulty; a new
concept to produce more meaningful outcome data. Gastrointest Endosc
2000; 51: 535-9
6)
Jowell PS,
Baillie J, Branch S, Affronti J, Browning CL, Bute BP.
Quantitative assessment of procedural competence: a prospective study of
training in endoscopic retrograde cholangio-pancreatography. Ann Intern Med
1996; 125: 983-9
JRBG/Draft 3/Aug07