Author: Wadsworth C.A.; Dwyer L.K.; Paranandi B.; Mahmood S.; Johnson G.J.; Chapman M.; Pereira S.P.; Stern N.; Singhal A.; Webster G.; Sturgess R.
Abstract: Background: Choledocholithiasis is the commonest indication for endoscopic retrograde cholangiopancreatography (ERCP). ERCP carries substantial risk of complication when compared to other endoscopic modalities. The identification of key performance indicators (KPIs) in colonoscopy practice and implementation of related standards has driven quality assurance in the UK and elsewhere. The failure to establish similar contemporary, meaningful and measurable KPIs in ERCP has hampered the development
of national standards. Aim: To quantify current performance in a potential new endoscopic KPI: the complete clearance of CBD stones at first ERCP. Method: Three centres participated in the study-one secondary and two tertiary HPB units. All patients undergoing first ERCP for confirmed or suspected choledocholithiasis over a twelve month period were included, data were analysed on an intention to treat basis. The primary endpoint was complete clearance of bile duct stones. Failure to clear stones was
defined as i) persisting stones reported ii) placement of biliary endoprosthesis, even if considered precautionary. Secondary endpoints were CBD cannulation, successful biliary decompression and complications. Outcomes were analysed by unit and by consultant clinician performing or supervising the procedure. A range of patient and endoscopist factors were recorded. Results: 592 patients were included in the study. 10 consultant endoscopists carried out or supervised the procedures. Overall, deep biliary cannulation was achieved in 536/592 (91%, range for three units 82-95%, p<0.05). Complete bile duct
clearance at first ERCP was achieved in 447/592 (76%, 66-81%, p<0.05). Endoscopist factors associated with success included larger annual ERCP caseload. Patient factors included low stone burden and normal ampullary anatomy. Clopidogrel use and acute pancreatitis were associated with lower chance of success. Discussion: We investigated the outcome of nearly 600 ERCP procedures, representing real-life practice in UK centres. Duct clearance was possible at first ERCP in three quarters of patients. There were significant differences in performance between units, and between individual clinicians. The reasons for this are not fully elucidated, but there is an association between larger ERCP caseload and success. The primary endpoint of this study has strengths as a potential KPI. It is clearly defined, measurable on an intention to treat basis and is strongly focussed on patient outcome. In addition, it quantifies performance in the commonest indication for ERCP, stone extraction, which is undertaken in all ERCP units. Although an acceptable success rate cannot be extrapolated from this data, it appears that a rate of O65% should be achievable. A larger study, including further centres, is underway.
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