1. PIER ALBERTO TESTONI, MD, ALBERTO MARIANI, MD, ANTONELLA GIUSSANI, MD, CRISTIAN VAILATI, MD, ENZO MASCI, MD, GIAMPIERO MACARRI, MD, LUIGI GHEZZO, MD, LUIGI FAMILIARI, MD, NICOLA GIARDULLO, MD, MASSIMILIANO MUTIGNANI, MD, GIOVANNI LOMBARDI, MD, GIORGIO TALAMINI, MD, ANTONIO SPADACCINI, MD, ROMOLO BRIGLIA, MD, LUCIA PIAZZI, MD AND THE SEIFRED GROUP AM J GASTROENTEROL, 6 APRIL 2010 Risk Factors for Post-ERCP Pancreatitis In High- and Low-Volume Centers and Among Expert and Non-Expert Operators: A Prospective Multicenter Study

2. INTRODUCTION Pancreatitis  Still one of the most feared and frequent complication asso/w endoscopic procedures involving the Vater’s papilla  Incidence range : <2% up to 40%  Causes of differences in the reported rates  Criteria used for definition  Data collection methods  Case mix : Factor with most influence  Levels of endoscopic expertise

3. INTRODUCTION Risk factors for Post-ERCP pancreatitis  Patient- and Procedure-related risk factors  In four prospective studies, standard- vs high-risk patients 1.6% and 7.8% (Gastroenterology 1991 ; 101 : 1068 – 75) 3.4% and 29.2% (Gastrointest Endosc 1994 ; 40 : 422 – 7) 3.6% and 19.1% (N Engl J Med 1996 ; 335 : 909 – 18) 0.4% and 18.8% (Am J Gastroenterol 2001 ; 96 : 417 – 23)  Endoscopist’s expertise  Center’s volume

4. INTRODUCTION Purpose - To Identify risk factor of post-ERCP pancreatitis - Patient-, Procedure- related risk factors - Endoscopist’s experience & Center’s case volume

5. METHODS – Study protocol Prospective Multicenter study  21 Study centers in Italy  By the University Vita-Salute San Raffaele GI Endoscopy Division  10(47.6 %) in the north, 5(23.8 %) in the center, and 6(28.6 %) in the south  11 high- and 10 low-volume centers  Period : 6 months (February – July 2007) Data  All consecutive ERCPs attempted during the study  Prospectively recorded data at the time of the ERCP  Data collection sheet  Patient ’ s main details and risk factors  Indication for the procedure  Technical details of the procedures  Final diagnosis  Procedure-related complications  Post-procedure clinical and enzymatic 24-h or 48-h course  Antibiotic and analgesic treatments

6. METHODS – Study protocol Exclusion criteria  Age < 18 years  Pregnancy or Mental disability  Active pancreatitis at the time of the procedure  Contrast allergy  Need for urgent ERCP within 12 hrs Biochemical tests  At the baseline : liver function, amylase, and CBC  Repeated 6 h and 24 h after : Amylase and CBC  Persistently high 24-h amylase : reassessed at 48 h Prophylaxis of post-ERCP pancreatitis  Pharmacological prophylaxis : avoided during the study period  Post-procedure pancreatic stenting in high-risk cases  High-volume centers : 3 / 11  Low-volume centers : 1 / 10

7. MATERIALS AND METHODS Patient variables  1) History of acute pancreatitis  2) Earlier ERCP-related pancreatitis  3) Acute recurrent pancreatitis  4) Female sex  5) Young age  6) Biliary pain  7 & 8) Diameter of common bile duct < 10 mm with the gallbladder and < 12 mm without  9) No bile duct stones  10) Normal serum transaminases and ALP  11) Bilirubin < 2 mg/dl

8. MATERIALS AND METHODS Technical variables 1) No. of attempts to cannulate the papilla (up to, or >10) 2) Cannulation of the MPD 3) Failed cannulation 4) Contrast injection into the pancreatic ductal system 5) Pancreatic acinarization after contrast injection 6) Needle knife pre-cut technique 7) Pancreatic sphincterotomy 8) Pneumatic dilatation of the biliary sphincter Operator variables 1) Total < 200 procedures and / or the current number < 40/year

9. MATERIALS AND METHODS Definition & Grade of Post-ERCP pancreatitis  1) Definition  Post-procedure, new-onset  Increased abdominal pain lasting more than 24 h  Amylase >3 times more than upper normal value  2) Grade  Mild : No local or systemic Cx. & uneventful recovery  Severe : Organ failure or local Cx. (Necrosis, Abscess etc) Statistics  SAS software  Χ 2 or Fisher’ s exact test for categorical variables  Univariate analysis and forward stepwise multiple logistic regression for risk factors for post-ERCP pancreatitis

10. RESULTS

11. High volume151~302 (mean: 257) Low volume9~75 (mean : 45) Expertise3331 Non-expertise304

14. Univariate analysis With variableWithout variableP Low-volume25 / 797 (3.1 % )112 / 2,838 (3.9 % )0.38 Low-experience9 / 163 (5.5 % )125 / 3,331 (3.8 % )0.34

15. Multiivariate analysis

16. CONCLUSION Post-ERCP pancreatitis was 1/3 higher among non-expert operators than experts but not significant. Mean pancreatitis rate did not significantly differ between high & low-volume centers. - limitation - 1) 25 % more patients with high risk for PEP 2) Significantly larger No. of procedures at the highest degree of difficulty.