ERCP – Provision of Service and of

Training in the Future

Jonathan GreenJonathan Green

University Hospital of North StaffsUniversity Hospital of North Staffs

Background

How it looked at the MillenniumHow it looked at the Millennium

Background - Service

Due to NHS Plan (18/52 wait) and BCSP, big Due to NHS Plan (18/52 wait) and BCSP, big focus on focus on ColonoscopyColonoscopy

Loss of diagnostic role (MRCP) for ERCPLoss of diagnostic role (MRCP) for ERCP Patchy growth of EUSPatchy growth of EUS Uneven (random) spread of skillsUneven (random) spread of skills Service need unclearService need unclear Service safety even more unclearService safety even more unclear Lack of guiding standards and principlesLack of guiding standards and principles

Background - Training

Training? Yes - but focussed on Training? Yes - but focussed on ColonoscopyColonoscopy Beginning of move from time-based to Beginning of move from time-based to

competence-based trainingcompetence-based training ERCP no longer mandatory for CCTERCP no longer mandatory for CCT Few trainees capable of independent practice Few trainees capable of independent practice

at CCTat CCT Training standards loosely defined Training standards loosely defined

Then - Then -

- the - the ‘Killer Blow’‘Killer Blow’ - -

NCEPOD 2004 – Scoping Our PracticeNCEPOD 2004 – Scoping Our Practice – – Deaths after Therapeutic EndoscopyDeaths after Therapeutic Endoscopy

“ “ 68% of the ERCPs undertaken 68% of the ERCPs undertaken were futile”were futile”

How to tackle this ?

A 3 pronged attackA 3 pronged attack

AUDIT -AUDIT - Current ERCP ServiceCurrent ERCP Service

STANDARDS –STANDARDS – Clear standards for Clear standards for service as well as service as well as trainingtraining

STRATEGY – STRATEGY – Clear strategy for future Clear strategy for future of service and trainingof service and training

BSG ERCP AuditBSG ERCP Audit

BSG Endoscopy Comm-BSG Endoscopy Comm-ittee ERCP Standards – ittee ERCP Standards – adopted by the JAGadopted by the JAG

BSG Endoscopy BSG Endoscopy Committee ERCP Committee ERCP ‘Stakeholder’ Group‘Stakeholder’ Group

AUDIT

BSG ERCP Audit - 2004

ProspectiveProspective In and Outpatient ERCPIn and Outpatient ERCP All casesAll cases 5 Regions of England5 Regions of England Data on 5264 ERCP’s by 213 ERCPistsData on 5264 ERCP’s by 213 ERCPists

BSG ERCP Audit - 2004

94% scheduled as therapeutic94% scheduled as therapeutic 77% of Trained Endoscopists had a 77% of Trained Endoscopists had a

cannulation rate of >80%cannulation rate of >80% 70% Completion of intended therapeutic 70% Completion of intended therapeutic

procedureprocedure 5.1% Complication rate (pancreatitis 1.6%)5.1% Complication rate (pancreatitis 1.6%) Procedure-related mortality 0.4%Procedure-related mortality 0.4%

STANDARDS

Quality Indicators in an ERCP service

1)Structure1)Structure

A minimum of 2 ERCP-trained endoscopists per A minimum of 2 ERCP-trained endoscopists per centre centre

An agreed minimum workload (procedure An agreed minimum workload (procedure type/volume) per endoscopisttype/volume) per endoscopist

An Endoscopy Unit caseload of at least 150 An Endoscopy Unit caseload of at least 150 procedures per year procedures per year

A nominated radiologist to lead Imaging Department A nominated radiologist to lead Imaging Department quality issuesquality issues

Quality Indicators in an ERCP service

2) Process2) Process

Evidence of consultant involvement in every decision Evidence of consultant involvement in every decision to perform (c/f request) ERCP e.g. by case note auditto perform (c/f request) ERCP e.g. by case note audit

Pre-ERCP pre-assessment of in-patients by Pre-ERCP pre-assessment of in-patients by appropriately trained staff member(s) appropriately trained staff member(s)

Less than 5% of ERCP’s intended as purely Less than 5% of ERCP’s intended as purely diagnostic examinationsdiagnostic examinations

Formal recording of adverse events e.g. significant Formal recording of adverse events e.g. significant complications and mortalitycomplications and mortality

Quality Indicators in an ERCP service

3) Outcome3) Outcome

Completion of the intended therapeutic procedure in Completion of the intended therapeutic procedure in at least 80% of casesat least 80% of cases

Clinically symptomatic pancreatitis in less than 5%Clinically symptomatic pancreatitis in less than 5% Post- sphincterotomy significant bleeding <2%Post- sphincterotomy significant bleeding <2% Sedation reversal agents used in <1%Sedation reversal agents used in <1% Evidence of patient acceptability/satisfaction e.g. from Evidence of patient acceptability/satisfaction e.g. from

audits, complaints (formal and informal)audits, complaints (formal and informal)

QUALITY INDICATORS IN ENDOSCOPY

QUALITYQUALITY SAFETYSAFETY

StructureStructure Min.Unit CaseloadMin.Unit Caseload Full Range of Full Range of AccessoriesAccessories

ProcessProcess Pre-assessment Pre-assessment of in-patientsof in-patients

Adverse incidents Adverse incidents recordrecord

Qual. IndicatorsQual. Indicators 80% Completion80% Completion Panc. <5%Panc. <5%

StaffingStaffing Min. 2 ERCPistsMin. 2 ERCPists Min. 3 nurse asst.Min. 3 nurse asst.

STRATEGY

The ‘Stakeholder Group’The ‘Stakeholder Group’

STAKEHOLDER GROUPThe constitution of the Group was as follows:-

Jonathan Green ChairmanMiles Allison BSG Endoscopy CommitteeHoward Smart BSG Endoscopy CommitteeRoland Valori National Endoscopy TeamMartin Lombard BSG ERCP AuditKel Palmer Chairman of JAG (till 12/06)Roger Barton Chairman of JAG (from 12/06)Derrick Martin Royal College of Radiologists

Nick Hayes AUGISDon Menzies AUGIS

The full group met twice –

February 2006 and March 2007 –

Sub-group meeting - October 2006.

Stakeholder Group

Summary of Summary of recommendations and recommendations and

conclusionsconclusions

Question 1

Is there a future for ERCP?Is there a future for ERCP?

Future Need for ERCPLikely future incidence of ERCP

0.9 per 1,000 per year

equating to 54,000 ERCP’s per year across

the UK.Importantly, the Group did not foresee

a reduction in the numbers of ERCP’s performed

over time.

Question 2

What specific standards should What specific standards should define an ERCP service and an define an ERCP service and an individual ERCP endoscopist?individual ERCP endoscopist?

ERCP Service

An ERCP Service should perform a minimum of

150 procedures per year

and

there must be more than one trained service deliverer to ensure continuity of service.

When an endoscopic service performs less procedures than this,

The Group recommends

a network with nearby hospitals -

to allow these minimum standards to be achieved.

ERCP Endoscopists

ERCP is currently performed by:- Medical Gastroenterologists (75%) Upper GI surgeons (13%) Others (12%) - including radiologists

ERCP Endoscopists

The Group felt that the only criteriafor performing ERCP were:-

Medical (c/f non-medical) backgroundProper (JAG defined) training Certified competence Adequate continued experience

ERCP Endoscopists

• ERCP endoscopists who wish to continue to partake in the ERCP service should currently aim to achieve a minimum of 75 cases per year.

This minimum standard will within a timeframe to be decided likely increase

• Those not currently 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)

Question 3

What is the future of training What is the future of training for ERCP?for ERCP?

TRAINING

Standards - Standards - for training and for training and accreditation to be determined by accreditation to be determined by competence –based assessmentscompetence –based assessments

NumberNumber - of trainees to be trained is - of trainees to be trained is determined by determined by FUTURE SERVICE FUTURE SERVICE NEEDNEED

Definition of Competence at CCT - 1

The Stakeholder Group would wish that at CCT an ERCP trainee would be competent to perform independent Level 1 ERCP .

Level 1 includes selective deep cannulation, biliary sphincterotomy and clearance of bile duct stones <10mm diameter and placement of stents for low pancreatic tumours

Definition of Competence at CCT - 2

80% successful completion of the intended procedure of Level 1 difficulty.

Required minimum performance of 200 procedures

Post-ERCP complication rate of < 5%. Complications defined as pancreatitis, significant haemorrhage, perforation or infection.

Probationary period

Trainee Numbers

• UK incidence of ERCP is expected to be 54,000

•Future expectation that a trained ERCP endo-scopist will perform at least 100 ERCP’s per year,

•National requirement for maximum of 540 trained ERCPists to deliver the service.

Trainee Numbers

•If each trained ERCP endoscopist has a 20 year service span

• Need for a minimum of 30 new trained ERCPists

to enter the service each year to balance retirement.

The suggested number of entrants ranged from 20-40 with a consensus of around 30.

Trainee Numbers

30 new entrants each year in the whole UK 30 new entrants each year in the whole UK means:-means:-

Training places restrictedTraining places restricted

Regional allocation – 1-2 places per regionRegional allocation – 1-2 places per region

How selected?How selected?

Trainee Selection No evidence-based method for reliably No evidence-based method for reliably

selecting those with the greatest potential of selecting those with the greatest potential of developing ERCP-related skills developing ERCP-related skills

Can be Top Down – regulated – restricted slotsCan be Top Down – regulated – restricted slots

or Bottom Up – free marketor Bottom Up – free market

It is not yet possible to determine which model will It is not yet possible to determine which model will predominate predominate

Mode of Training

Current ERCP training is Current ERCP training is haphazard haphazard CCT currently gives no indication of either CCT currently gives no indication of either

exposure to or level of competence at ERCP exposure to or level of competence at ERCP

An alternative model is suggested An alternative model is suggested Concept of Concept of ‘fellowship’ in specialised ‘fellowship’ in specialised

endoscopyendoscopy training – 6-12 months of 6-7 training – 6-12 months of 6-7 weekly sessions of specialist endoscopy – weekly sessions of specialist endoscopy – across the network – integral part of STacross the network – integral part of ST

Trainer Requirements

Criteria for ERCP trainer endoscopists :Criteria for ERCP trainer endoscopists : Participation in at least 75 procedures per yearParticipation in at least 75 procedures per year Working in a network with a workload of Working in a network with a workload of

averaging over 150 procedures per year averaging over 150 procedures per year Continuous audit Continuous audit complication rates of < 5% complication rates of < 5% >>90%90% completion of intended therapy @ level 1 completion of intended therapy @ level 1 Faculty or Observer at ERCP Training Events Faculty or Observer at ERCP Training Events

outside own network at least once every 5 yrs. outside own network at least once every 5 yrs.

Progress and Status of Recommendations

PROGRESS

Full document now Full document now approvedapproved by:- by:-

Endoscopy CommitteeEndoscopy Committee

BSG CouncilBSG Council

Royal College of RadiologistsRoyal College of Radiologists

AUGISAUGIS

So now So now endorsedendorsed by by the JAGthe JAG

Will shortly appear on BSG and JAG Will shortly appear on BSG and JAG websiteswebsites

Next StepsTRAININGTRAINING

*Strategy document now submitted now to *Strategy document now submitted now to SACsSACs in Gastro., Surgery and Radiologyin Gastro., Surgery and Radiology

*SACs – to report back:- *SACs – to report back:- ‘‘upwards’upwards’ - to Joint Training Boards (eg JRCPTB)- to Joint Training Boards (eg JRCPTB)

‘‘downwards’ downwards’ - to the JAG (‘sideways’ actually!)- to the JAG (‘sideways’ actually!)

*Recommendations to be forwarded to PMETB. *Recommendations to be forwarded to PMETB. In particular, the 6 In particular, the 6 or 12 month ‘fellowship’ training periods need to be included or 12 month ‘fellowship’ training periods need to be included (and thus funded by PMETB) as a standard option in the later (and thus funded by PMETB) as a standard option in the later years of Higher Specialist Training for appropriate traineesyears of Higher Specialist Training for appropriate trainees

Next Steps

SERVICESERVICE

The JAG:-The JAG:- Now incorporatesNow incorporates all the service standards all the service standards

into into its accreditation criteria of Endoscopy Unitsits accreditation criteria of Endoscopy Units NotesNotes that the methodology used in a that the methodology used in a

complex complex area of specialist endoscopy can area of specialist endoscopy can equally be equally be applied to other areas of specialist applied to other areas of specialist endoscopy endoscopy in need of similar reviewin need of similar review

SUMMARY

Considerable progress achieved in the last 2-3 Considerable progress achieved in the last 2-3 years:-years:-

We now know what goes on in ERCPWe now know what goes on in ERCP We have set credible standards both for service We have set credible standards both for service

and trainingand training We have set a framework for the future of bothWe have set a framework for the future of both

But this is just the first few steps – But this is just the first few steps – more needed!more needed!

ERCP – A vision of the future?

SpRRep

Bored nurses

Ageing Stressed consultant

TEAMWORK