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OBJECTIVES:A recent large-scale randomized controlled trial (RCT) demonstrated that rectal indomethacin administration is effective in addition to pancreatic stent placement (PSP) for preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in high-risk cases. We performed a post hoc analysis of this RCT to explore whether rectal indomethacin can replace PSP in the prevention of PEP and to estimate the potential cost savings of such an approach.METHODS:We retrospectively classified RCT subjects into four prevention groups: (1) no prophylaxis, (2) PSP alone, (3) rectal indomethacin alone, and (4) the combination of PSP and indomethacin. Multivariable logistic regression was used to adjust for imbalances in the prevalence of risk factors for PEP between the groups. Based on these adjusted PEP rates, we conducted an economic analysis comparing the costs associated with PEP prevention strategies employing rectal indomethacin alone, PSP alone, or the combination of both.RESULTS:After adjusting for risk using two different logistic regression models, rectal indomethacin alone appeared to be more effective for preventing PEP than no prophylaxis, PSP alone, and the combination of indomethacin and PSP. Economic analysis revealed that indomethacin alone was a cost-saving strategy in 96% of Monte Carlo trials. A prevention strategy employing rectal indomethacin alone could save approximately $150 million annually in the United States compared with a strategy of PSP alone, and $85 million compared with a strategy of indomethacin and PSP.CONCLUSIONS:This hypothesis-generating study suggests that prophylactic rectal indomethacin could replace PSP in patients undergoing high-risk ERCP, potentially improving clinical outcomes and reducing healthcare costs. A RCT comparing rectal indomethacin alone vs. indomethacin plus PSP is needed. [ABSTRACT FROM AUTHOR]

OBJECTIVES: Pancreatitis is the most common and serious complication of diagnostic and therapeutic ERCP. The aim of this study is to examine the potential patient- and procedure-related risk factors for post-ERCP pancreatitis in a prospective multicenter study. METHODS: A 160-variable database was prospectively collected by a defined protocol on patients undergoing diagnostic or therapeutic ERCP at 15 centers in the Midwest Pancreaticobiliary Group and participating in a randomized controlled study evaluating whether prophylactic corticosteroids will reduce the incidence of post-ERCP pancreatitis. Data were collected prior to the procedure, at the time of procedure, and 24–72 h after discharge. Post-ERCP pancreatitis was diagnosed and its severity graded according to consensus criteria. RESULTS: Of the 1,115 patients enrolled, diagnostic ERCP with or without sphincter of Oddi manometry (SOM) was performed in 536 (48.1%) and therapeutic ERCP in 579 (51.9%). Suspected sphincter of Oddi dysfunction (SOD) was the indication for the ERCP in 378 patients (33.9%). Pancreatitis developed in 168 patients (15.1%) and was graded mild in 112 (10%), moderate in 45 (4%), and severe in 11(1%). There was no difference in the incidence of pancreatitis or the frequency of investigated potential pancreatitis risk factors between the corticosteroid and placebo groups. By univariate analysis, the incidence of post-ERCP pancreatitis was significantly higher in 19 of 30 investigated variables. In the multivariate risk model, significant risk factors with adjusted odds ratios (OR) were: minor papilla sphincterotomy (OR: 3.8), suspected SOD (OR: 2.6), history of post-ERCP pancreatitis (OR: 2.0), age <60 yr (OR: 1.6), ≥2 contrast injections into the pancreatic duct (OR: 1.5), and trainee involvement (OR: 1.5). Female gender, history of recurrent idiopathic pancreatitis, pancreas divisum, SOM, difficult cannulation, and major papilla sphincterotomy (either biliary or pancreatic) were not multivariate risk factors for post-ERCP pancreatitis. CONCLUSION: This study emphasizes the role of patient factors (age, SOD, prior history of post-ERCP pancreatitis) and technical factors (number of PD injections, minor papilla sphincterotomy, and operator experience) as the determining high-risk predictors for post-ERCP pancreatitis. [ABSTRACT FROM AUTHOR]

: ObjectiveERCP is frequently the technique of choice for the diagnosis and palliative treatment of pancreaticobiliary neoplasms. The sensitivity of tissue sampling techniques has been disappointing. Two small series have reported a high diagnostic yield from cytological examination of cellular debris from removed biliary stents. The aim of this study was to determine the clinical utility of stent cytology for the diagnosis of biliary and pancreatic neoplasia.: MethodsPatients who had biliary or pancreatic stents removed at ERCP and evaluated cytologically were the subjects of this study. Stents were scraped and washed, and the cellular debris was examined cytologically and recorded as positive, atypical, or negative. Patient demographics, ductal stricture, and stent characteristics were recorded.: ResultsBetween January, 1994 and January, 2001 a total of 126 biliary stents from 101 patients (61 male, 40 female, mean age 62 yr) and 29 pancreatic stents from 19 patients (seven male, 12 female, mean age 58 yr) were examined. The sensitivity, specificity, positive predictive value, and negative predictive value of biliary and pancreatic stents for the diagnosis of neoplasia were: 11%, 100%, 100%, 53%, and 25%, 100%, 100%, 77.8%, respectively. The sensitivity improved slightly if all degrees of atypia were considered positive for neoplasia. The mean duration of stent placement was 93.6 days for biliary stents and 43.5 days for pancreatic stents.: ConclusionsBiliary and pancreatic stent cytology has limited clinical utility in the diagnosis of pancreaticobiliary neoplasia, owing to poor sensitivity. In addition, the time lag between stent placement and removal for cytologic examination further limits its contribution to patient management. [Copyright &y& Elsevier]