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1.  Does Rectal Indomethacin Eliminate the Need for Prophylactic Pancreatic Stent Placement in Patients Undergoing High-Risk ERCP? Post hoc Efficacy and Cost-Benefit Analyses Using Prospective Clinical Trial Data 
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.
doi:10.1038/ajg.2012.442
PMCID: PMC3947644  PMID: 23295278
2.  Multicenter Randomized Trial of 10-French versus 11.5-French Plastic Stents for Malignant Biliary Obstruction 
Background. There is little prospective data on whether bigger plastic stents are better for patients with malignant biliary obstruction with jaundice. Goals. Multicenter prospective study to compare technical success, clinical response, stent occlusion, and patient survival in patients with malignant biliary obstruction randomized to 10-French or 11.5-French plastic stent. Study. Patients with malignant biliary obstruction were randomized to 10-French or 11.5-French biliary stents. Patients were prospectively assessed for stent occlusion, stent-related interventions, hospital stay, and change in bilirubin. Main outcome measurements included technical success, clinical response, rates of stent occlusion, and survival. Results. 234 patients (47 hilar and 187 common bile duct strictures) were randomized. Outcomes were similar for the 10-French and 11.5-French groups (technical success 99.1% versus 97.4%, P = 0.37). Overall, median stent survival was 213 days, but there was no statistically significant difference in stent survival between 10-French and 11.5-French stents (149 versus 258 days, P = 0.16). Stent survival was significantly longer when placed for common bile duct versus hilar strictures (231 versus 115 days, P = 0.049). Conclusions. The theoretical advantage of improved bile flow for the 11.5-French stent does not translate into more prolonged patency, better clinical response, and longer patient survival than the 10-French stent.
doi:10.1155/2013/891915
PMCID: PMC3659511  PMID: 23737656
3.  A Randomized Trial of Rectal Indomethacin to Prevent Post-ERCP Pancreatitis 
The New England Journal of Medicine  2012;366(15):1414-1422.
Background
Preliminary research suggests that rectally administered nonsteroidal antiinflammatory drugs may reduce the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP).
Methods
In this multicenter, randomized, placebo-controlled, double-blind clinical trial, we assigned patients at elevated risk for post-ERCP pancreatitis to receive a single dose of rectal indomethacin or placebo immediately after ERCP. Patients were determined to be at high risk on the basis of validated patient- and procedure-related risk factors. The primary outcome was post-ERCP pancreatitis, which was defined as new upper abdominal pain, an elevation in pancreatic enzymes to at least three times the upper limit of the normal range 24 hours after the procedure, and hospitalization for at least 2 nights.
Results
A total of 602 patients were enrolled and completed follow-up. The majority of patients (82%) had a clinical suspicion of sphincter of Oddi dysfunction. Post-ERCP pancreatitis developed in 27 of 295 patients (9.2%) in the indomethacin group and in 52 of 307 patients (16.9%) in the placebo group (P = 0.005). Moderate-to-severe pancreatitis developed in 13 patients (4.4%) in the indomethacin group and in 27 patients (8.8%) in the placebo group (P = 0.03).
Conclusions
Among patients at high risk for post-ERCP pancreatitis, rectal indomethacin significantly reduced the incidence of the condition. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT00820612.)
doi:10.1056/NEJMoa1111103
PMCID: PMC3339271  PMID: 22494121
4.  Moderate and severe postendoscopic retrograde cholangiopancreatography pancreatitis despite prophylactic pancreatic stent placement: The effect of early prophylactic pancreatic stent dislodgement 
BACKGROUND:
Placement of prophylactic pancreatic stents (PPS) is a method proven to reduce the rate and severity of postendoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in high-risk patients; however, PPS do not eliminate the risk completely. Early PPS dislodgement may occur prematurely and contribute to more frequent or severe PEP.
OBJECTIVE:
To determine the effect of early dislodgement of PPS in patients with moderate or severe PEP.
METHOD:
A total of 27,176 ERCP procedures from January 1994 to September 2007 for PPS placement in high-risk patients were analyzed. Patient and procedure data were analyzed to assess risk factors for PEP, and to evaluate the severity of pancreatitis, length of hospitalization and subsequent complications. Timing of stent dislodgment was assessed radiographically.
RESULTS:
PPS were placed in 7661 patients. Of these, 580 patients (7.5%) developed PEP, which was graded as mild in 460 (6.0%), moderate in 87 (1.1%) and severe in 33 (0.4%). Risk factors for developing PEP were not different in patients who developed moderate PEP compared with those with severe PEP. PPS dislodged before 72 h in seven of 59 (11.9%) patients with moderate PEP and five of 27 (18.5%) patients with severe PEP (P=0.505). The mean (± SD) length of hospitalization in patients with moderate PEP with stent dislodgement before and after 72 h were 7.43±1.46 days and 8.37±1.16 days, respectively (P=0.20). The mean length of hospitalization in patients with severe PEP whose stent dislodged before and after 72 h were 21.6±6.11 and 22.23±3.13 days, respectively (P=0.96).
CONCLUSION:
Early PPS dislodgement was associated with moderate and severe PEP in less than 20% of cases and was not associated with a more severe course. Factors other than ductal obstruction contribute to PEP in high-risk patients undergoing ERCP and PPS placement.
PMCID: PMC3088697  PMID: 21523263
Complications; ERCP; Pancreatic stent; Post-ERCP pancreatitis
5.  Update on Endoscopic Management of Main Pancreatic Duct Stones in Chronic Calcific Pancreatitis 
Pancreatic duct stones are a common complication during the natural course of chronic pancreatitis and often contribute to additional pain and pancreatitis. Abdominal pain, one of the major symptoms of chronic pancreatitis, is believed to be caused in part by obstruction of the pancreatic duct system (by stones or strictures) resulting in increasing intraductal pressure and parenchymal ischemia. Pancreatic stones can be managed by surgery, endoscopy, or extracorporeal shock wave lithotripsy. In this review, updated management of pancreatic duct stones is discussed.
doi:10.3904/kjim.2012.27.1.20
PMCID: PMC3295984  PMID: 22403495
Pancreatitis, chronic; Calculi; Endoscopy; Lithotripsy; Surgery
6.  Update on Endoscopic Treatment of Chronic Pancreatitis 
Endoscopic therapy has been increasingly recognized as the effective therapy in selected patients with chronic pancreatitis. Utility of endotherapy in various conditions occurring in chronic pancreatitis is discussed. Its efficacy, limitations, and alternatives are addressed. For the best management of these complex entities, a multidisciplinary approach involving expertise in all pancreatic specialties is essential to achieve the goal.
doi:10.3904/kjim.2009.24.3.169
PMCID: PMC2732774  PMID: 19721851
Chronic pancreatitis; Endoscopic treatment
7.  The effect of biliary sphincterotomy on serum cholesterol levels in postcholecystectomy patients: A pilot study 
BACKGROUND:
Cholesterol, in the form of bile salts, is reabsorbed from the small intestine via the enterohepatic circulation. Biliary sphincterotomy increases the delivery of bile to the terminal ileum. If the absorptive capacity is exceeded, cholesterol excretion may increase, resulting in a decrease in serum cholesterol levels and improvement in serum lipid profiles.
AIM:
To determine the effect of biliary sphincterotomy on serum cholesterol levels in patients without biliary obstruction.
PATIENTS AND METHODS:
Postcholecystectomy patients with type III biliary sphincter of Oddi dysfunction (disabling pancreatobiliary-type pain with normal liver function tests and bile duct diameter) who underwent biliary sphincterotomy were identified retrospectively from the endoscopic retrograde cholangiopancreatography database. Baseline (pre-endoscopic retrograde cholangiopancreatography) laboratory investigations (including cholesterol) were obtained for all patients. The effect of sphincterotomy on total cholesterol levels was noted in all patients who returned for subsequent procedures (temporary pancreatic stent removal or evaluation of recurrent symptoms), and also in the subgroup of patients with baseline hypercholesterolemia (higher than 5.18 mmol/L).
RESULTS:
In the present pilot study, the performance of biliary sphincterotomy was associated with a reduction in total serum cholesterol levels in postcholecystectomy patients without biliary obstruction. This was statistically significant in patients with a baseline cholesterol level higher than 5.18 mmol/L. A possible effect on low-and high-density lipoprotein concentrations was not evaluated. The influence of dietary changes and exercise were not accounted for.
CONCLUSION:
A prospective, controlled study involving a larger series of patients is required to determine whether biliary sphincterotomy lowers cholesterol levels and improves lipid profiles.
PMCID: PMC2657665  PMID: 17299610
Biliary sphincterotomy; Cholesterol levels; Postcholecystectomy

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