153

Endoscopy III Quality in endoscopy

Sun

da

y, O

ctO

bEr

23

08:

30 –

10:3

0

ErcP: MInIMal StandardS and traInIng rEquIrEMEntS

Olivier le MoineBelgium

lEarnIng ObjEctIvES

To understand 1. That quality in ercp is not only related to the procedure itself 2. That ercp has definitely moved to therapeutic interventions 3. That standards and guidelines are currently available 4. That adequate training will be dependent on Units credential-

ing, adaptation of the number of trainees, development of pre-clinical training methods, quality indicators and life-time com-petence assessment

middle-aged in expert hands [1, 2]. Also in pregnant women fears about fetus radiation (accepted threshold of less than 50 mGray) can be dramatically decreased by adequate shielding, collimation, use of pulsed fluoroscopy, limiting beam exposition & image ac-quisition and adapting patient position [3]. Balancing risks and benefits for a given indication is better evaluated in a multidiscipli-nary team and allows a therapeutic planning in case of ercp failure. Involving the patient and his family in the consent process with adequate information and communication on a good indication for ercp is the basis to reduce lawsuits in case of complications [4, 5]. During ercp, as far as prevention of complications is concerned, we have to deal with infections, pancreatitis, bleeding and perfora-tion. Recent international guidelines are available which can help reducing the occurrence of those complications [6-9]. Basic thera-peutic ercp (Schutz Grade 1, see Table 2) includes selective deep canulation of the bile duct, sphincterotomy or sphincteroplasty for access, tissue sampling for pathology, stone extraction and stenting in normal anatomy. Again technical guidelines are availa-ble to achieve the best current care in this settings [10-12]. Ade-quate staffing of the Unit, availability of therapeutic scopes and a basic set of ancillary devices (including mechanical lithotriptor) and availability of anesthesia and recovery facilities are essential for quality provision [13, 14]. Radiation protection for both staff members and patients is an important issue which is not always taken into account. Repeated non protected exposure to Xrays

ERCP is already a 40 years old procedure. At the beginning it was a pure diagnostic procedure evolving during the seventies and eighties to therapeutic interventions as biliary sphincterotomy, stenting, pancreatic sphincterotomy and cyst-gastrostomy. Tech-nical improvements have exploded thanks to pioneers and compa-nies involved in the field. The nineties have seen the development of magnetic resonance cholangio-pancreatography (MRCP) as a non-invasive challenger of ercp for diagnostic purposes. From that time and up to now, ercp became primarily therapeutic and MRCP (when available) the first choice for diagnosis and multidisciplina-ry therapeutic planning. With the widening range of interven-tions, increasing number of procedures and extension of ercp pro-cedures outside of expert centers, questions raised during the last decade about how to assess the service provided to patients and how to adequately train the trainers and trainees and maintain their competences. a. Pre-, per- and post-ercp quality provision: Many fellows and trainees consider that ercp training is only inside of the ercp room. The reality is much more wider and includes many points before and after the procedure that must be integra-ted in the curriculum (see Table 1 for a non exhaustive list).

Before ercp, patient’s condition and age often lead to discussion facing a good indication (ie stones disease). It is more and more established that children and very old patients might benefit from therapeutic ercp with the same success and complication rates as

154

Endoscopy III Quality in endoscopy

Sun

da

y, Oc

tOb

Er 23

08:30

– 10:30

Olivier Le Moine | ErcP: MInIMal StandardS and traInIng rEquIrEMEntS

may lead to cancer, blindness, skin lesions, gonadal mutations and many others. European Union funded projects are ongoing to coll-ect data on exposure ( http://www.eman-network.eu ) and provi-de information and education on this matter ( http://www.medra-pet.eu ). Guidelines on endoscopes disinfection are also available and should be followed and adapted according to national rules [15]. After ercp: recording of the findings and treatment should better be electronic and structured with a terminology that allows to extract data easily for research or benchmarking (see later). The latest version of Minimal Standard Terminology for Digestive En-doscopy is available on the net ( http://www.worldendo.org/mst.html ). Short term and long term complications should also be re-corded. Finally, in case of complication, patient and family infor-mation and continuous communication is the best way to avoid misunderstandings. b. Credentialing of Units and continuing as-sessment: It is already known that case volume for an endoscopist is mandatory to achieve successful procedures and decrease the complications rate [17-19]. More data are now available about na-tionwide frequency of low volume ercp practitioners and the im-pact on outcomes. In North America 75% of practitioners perform < 100 ercps /yr [20] and 38% less than 50/yr [21], in Canada, UK, Sweden and Austria: 40%, 61%, 75% and 76% perform < 50 ercps /yr, respectively [22-25]. High volume practitioners and centers have lower hospital stay, less failure rate and less complications [20, 25] which might be important in terms of healthcare resources al-location and fulfillment of training programs. Therefore, some na-tional societies tried to define the best indicators which could help setting up benchmarking for credentialing ercp units in terms of quality provision. In the US, these indicators were associated with a grade of recommendation according to EBM [26], in UK, a Glo-bal Rating Scale (GRS) was developed and implemented for accre-ditation of Units and re-inspection follow-up [27] ( http://www.grs.nhs.uk ). As far as follow-up accreditation is considered, Units must show > 200 ercps/yr and individual trainers > 75 with a the-rapeutic success rate of > 90% and a complication rate < 5%. As such, a lot of work is ongoing for benchmarking and improving ercp services, hence providing a better breeding ground for trai-nees. c. Training in ercp: With the widespread use of MRCP as a diagnostic tool, the overall number of ercp’s decreased and most (>95%) have now a therapeutic intent. This means that the wor-kload of diagnostic cholangiography with native papilla has dra-matically decreased for training purposes. Moreover, the total number of ercp’s currently remains stable in the range of 0,7 to 1,2 / 1000 inhabitants in North America and Europe. With the state-ment that most endoscopy units perform < 50 ercp/yr (see above) and that 150-200 procedures are required for basic ercp compe-tences at the end of GI fellowship in most national programs (Ta-ble 3), one can ask how it might be possible. A recent study from UK highlighted this problem suggesting that there are too many trainees in too many low-volume centers for a fixed national wor-kload [27]. The suggestion is to adapt the number of trainees and concentrate ercp resources in approved units for intensive one year training [28].

rEfErEncES1. Bang, J.Y.V., S., ERCP in Children. Nat. Rev. Gastroenterol.

Hepatol., 2011. 8: p. 254-55. 2. Katsinelos, P., et al., Efficacy and safety of therapeutic ERCP

in patients 90 years of age and older. Gastrointestinal endos-copy, 2006. 63(3): p. 417-23.

3. Baron, T.H. and B.A. Schueler, Pregnancy and radiation ex-posure during therapeutic ERCP: time to put the baby to bed? Gastrointestinal endoscopy, 2009. 69(4): p. 832-4.

4. Cotton, P.B., Analysis of 59 ERCP lawsuits; mainly about in-dications. Gastrointestinal endoscopy, 2006. 63(3): p. 378-82; quiz 464.

5. Cotton, P.B., Twenty more ERCP lawsuits: why? Poor indica-tions and communications. Gastrointestinal endoscopy, 2010. 72: p. 904.

6. Anderson, M.A., et al., Management of antithrombotic agents for endoscopic procedures. Gastrointestinal endoscopy, 2009. 70(6): p. 1060-70.

7. Banerjee, S., et al., Antibiotic prophylaxis for GI endoscopy. Gastrointestinal endoscopy, 2008. 67(6): p. 791-8.

8. Boustiere, C., et al., Endoscopy and antiplatelet agents. Euro-pean Society of Gastrointestinal Endoscopy (ESGE) Guide-line. Endoscopy, 2011. 43(5): p. 445-61.

9. Dumonceau, J.M., et al., European Society of Gastrointestinal Endoscopy (ESGE) Guideline: prophylaxis of post-ERCP pancreatitis. Endoscopy, 2010. 42(6): p. 503-15.

10. Rey, J.F., et al., European Society of Gastrointestinal Endos-copy (ESGE) guideline: the use of electrosurgical units. En-doscopy, 2010. 42(9): p. 764-72.

11. Verma, D., A. Kapadia, and D.G. Adler, Pure versus mixed electrosurgical current for endoscopic biliary sphincterotomy: a meta-analysis of adverse outcomes. Gastrointestinal endos-copy, 2007. 66(2): p. 283-90.

12. Dumonceau, J.M., et al., Biliary stents: models and methods for endoscopic stenting. Endoscopy, 2011. 43(7): p. 617-26.

13. Jain, R., et al., Minimum staffing requirements for the perfor-mance of GI endoscopy. Gastrointestinal endoscopy, 2010. 72(3): p. 469-70.

14. Mazanikov, M., et al., Patient-controlled sedation with propo-fol and remifentanil for ERCP: a randomized, controlled study. Gastrointestinal endoscopy, 2011. 73(2): p. 260-6.

15. Beilenhoff, U., et al., ESGE-ESGENA Guideline: cleaning and disinfection in gastrointestinal endoscopy. Endoscopy, 2008. 40(11): p. 939-57.

16. Chutkan, R.K., et al., ERCP core curriculum. Gastrointesti-nal endoscopy, 2006. 63(3): p. 361-76.

17. Freeman, M.L., et al., Complications of endoscopic biliary sphincterotomy. The New England journal of medicine, 1996. 335(13): p. 909-18.

18. Loperfido, S., et al., Major early complications from diagnos-tic and therapeutic ERCP: a prospective multicenter study. Gastrointestinal endoscopy, 1998. 48(1): p. 1-10.

155

Endoscopy III Quality in endoscopy

Sun

da

y, O

ctO

bEr

23

08:

30 –

10:3

0

ErcP: MInIMal StandardS and traInIng rEquIrEMEntS | Olivier Le Moine

19. Rabenstein, T., et al., Impact of skill and experience of the en-doscopist on the outcome of endoscopic sphincterotomy techniques. Gastrointestinal endoscopy, 1999. 50(5): p. 628-36.

20. Varadarajulu, S., et al., Relationship among hospital ERCP volume, length of stay, and technical outcomes. Gastrointesti-nal endoscopy, 2006. 64(3): p. 338-47.

21. Cote, G.A., et al., Individual and practice differences among physicians who perform ERCP at varying frequency: a na-tional survey. Gastrointestinal endoscopy, 2011. 74(1): p. 65-73 e12.

22. Hilsden, R.J., J. Romagnuolo, and G.R. May, Patterns of use of endoscopic retrograde cholangiopancreatography in a Cana-dian province. Canadian journal of gastroenterology = Jour-nal canadien de gastroenterologie, 2004. 18(10): p. 619-24.

23. Williams, E.J., et al., Are we meeting the standards set for en-doscopy? Results of a large-scale prospective survey of endo-scopic retrograde cholangio-pancreatograph practice. Gut, 2007. 56(6): p. 821-9.

24. Enochsson, L., et al., Nationwide, population-based data from 11,074 ERCP procedures from the Swedish Registry for Gall-stone Surgery and ERCP. Gastrointestinal endoscopy, 2010. 72(6): p. 1175-84, 1184 e1-3.

25. Kapral, C., et al., Case volume and outcome of endoscopic ret-rograde cholangiopancreatography: results of a nationwide Austrian benchmarking project. Endoscopy, 2008. 40(8): p. 625-30.

26. Baron, T.H., et al., Quality indicators for endoscopic retro-grade cholangiopancreatography. Gastrointestinal endoscopy, 2006. 63(4 Suppl): p. S29-34.

27. Isaacs, P., Endoscopic retrograde cholangiopancreatography training in the United Kingdom: A critical review. World journal of gastrointestinal endoscopy, 2011. 3(2): p. 30-3.

28. Rosenthal, L.S., Is a fourth year of training necessary to be-come competent in EUS and ERCP? Notes from the 2008 class of advanced endoscopy fellows. Gastrointestinal endos-copy, 2008. 68(6): p. 1150-2.

29. Faigel, D.O. and P.B. Cotton, The London OMED position statement for credentialing and quality assurance in digestive endoscopy. Endoscopy, 2009. 41(12): p. 1069-74.

POlIcy Of full dISclOSurENone declared

Table 1:Before erCP Accurate tentative diagnosis

Correct indicationPatient conditionPatient agePatient & family informationTherapeutic plan

Clin, Lab, US, MrCP, Ct scan,…

ASA, coag disorders, pregnancy …Child, adult, older personsConsent communicationMultidisciplinary team

Per ProCedUre

Antibiotic Prophylaxis Procedure

disinfection, singleusereportingPlan in case of failure

Human resources (staff)endoscopes and devicesradioprotection (staff and patient)TraceabilityStructured terminologydelay to alternative treatment

PoST ProCedUre

Short term complicationsPatient & family informationfollow-upLong term complications

reportingcommunicationreportingreporting

Table 2: Schutz erCP grading of difficulty (adapted from [16])biliary procedure Pancreatic procedure

GrAde 1 diagnostic CholangiogramBiliary brush cytologyStandard biliary Sphincterotomyremoval of stones <10mmsdilatation/stent/NBd for extra hepatic stricture or leak

diagnostic pancreatogramPancreatic brush cytology

GrAde 2 diagnostic Cholangiogram in BII anatomyremoval of CBd stones >10mmsdilatation/stent/NBd for hilar or intrahepatic strictures

diagnostic pancreatogram in BII anatomyMinor papilla cannulation

GrAde 3 Sphincter manometryCholangioscopyAny therapy with BII anatomy

removal of intrahepatic stones or any stones with lithotripsy

Sphincer manometryPancreatoscopyAll pancreatic therapy, including cyst drainage

Table 3: threshold numer of endoscopic procedure before competency can be assessed by direct observation or other objective measures, as required in different countries or regions. (adapted from [29])

USA Australia Canada Poland India europeColonoscopyeGderCPeUS

140130200150

100200200200

150150200

500500200

120140190

150150200150