A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis.

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.).

The risk of post-ERCP pancreatitis and the protective effect of rectal indomethacin in cases of attempted but unsuccessful prophylactic pancreatic stent placement.

BACKGROUND: It is believed, based on limited observational data, that an unsuccessful attempt to place a prophylactic pancreatic stent substantially increases the risk of post-ERCP pancreatitis (PEP). OBJECTIVE: To better understand the risk of PEP in patients with failed pancreatic stent placement (FPS) and the impact of rectal indomethacin on this risk. DESIGN: Secondary analysis of randomized, controlled trial data. SETTING: University of Michigan and Indiana University. PATIENTS: A total of 577 clinical trial participants at elevated risk for PEP. INTERVENTIONS: Pancreatic stent placement. MAIN OUTCOME MEASUREMENTS: Within the placebo group, we compared PEP rates in patients with FPS, patients who underwent successful stent placement, and in those without a stent attempt. We also performed a regression analysis evaluating the association between FPS and PEP. To define the protective effect of indomethacin, we repeated these analyses in the indomethacin group and in the full study cohort. RESULTS: The incidence of PEP among patients in the placebo group who experienced FPS was 34.7%, significantly exceeding rates in patients who underwent successful stent placement (16.4%) and in those without a stent attempt (12.1%). After we adjusted for known PEP risk factors, FPS was found to be independently associated with PEP. Among the indomethacin group and in the full cohort, FPS was not associated with a higher risk of PEP. LIMITATIONS: Low event rate, FPS not prospectively captured. CONCLUSION: FPS appears to confer an increased risk of PEP, which is attenuated by rectal indomethacin administration. These findings highlight the importance of adequate training and proficiency before endoscopists attempt pancreatic stent placement and the routine use of rectal indomethacin in high-risk ERCP cases.

EUS Diagnostic Criteria for Chronic Pancreatitis: A Comparison of Conventional Versus Rosemont Criteria.

OBJECTIVE: To compare the Rosemont criteria, which are graded features chosen by experts in 2007, versus the conventional criteria, which require ≥ 3-5 of the 9 features that are "counted as equal," for the diagnosis of chronic pancreatitis by EUS. METHODS: This is a retrospective cohort study. EUS examinations were scored using both criteria, and the following categories compared: 3-CC versus "consistent with" chronic pancreatitis by RC; 3-CC versus "consistent with" and "suggestive of" chronic pancreatitis by RC; 5-CC versus "consistent with" chronic pancreatitis by RC; and 5-CC versus "consistent with" and "suggestive of" chronic pancreatitis by RC. RESULTS: There was a statistically significant difference between 3-CC and RC, either "consistent with" alone or both "consistent with" and "suggestive of" (p < 0.0001). Comparing 5-CC and "consistent with" showed a statistical difference (p = 0.0014), but no difference comparing 5-CC to "consistent with" and "suggestive of." CONCLUSION: CC diagnose more cases of chronic pancreatitis than RC when using 3-CC or when comparing 5-CC to "consistent with" chronic pancreatitis by Rosemont, indicating that the Rosemont criteria are more stringent.

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.

Do breaks in gastroenterology fellow endoscopy training result in a decrement in competency in colonoscopy?

BACKGROUND: Skills decay without practice, but the degree is task specific. Some experts believe that it is essential to teach endoscopy longitudinally to build and maintain endoscopic skills. OBJECTIVE: To determine whether breaks in gastroenterology fellow endoscopy training are associated with a decrement in competency in independent intubation of the cecum. DESIGN: Observational cohort of colonoscopies performed by gastroenterology fellows. SETTING: Academic fellowship program from July 2010 to March 2012. SUBJECTS: Twenty-four fellows. MAIN OUTCOME MEASUREMENTS: The adjusted change in the slope of cumulative summation learning curves for cecal intubation after breaks in training and the slope at the end of the subsequent endoscopy rotation. RESULTS: A total of 6485 colonoscopies were performed by 24 fellows with 87 breaks in training. The average break was 6 weeks (range 2-36 weeks). Seventy-five percent of the breaks were 8 weeks or less. For every additional 4 weeks, the slope after the break worsened by 0.022 (P = .06, maximum possible change = -1.0 to +1.0). By the end of the subsequent rotation, there was no association between the slope of the learning curve and the length of the break (P = .68). LIMITATIONS: This was an observational study of only 24 fellows with relatively few long breaks. Cecal intubation is only 1 component of overall competency in colonoscopy. CONCLUSIONS: There may be a very small decrement in fellows' abilities to intubate the cecum after a break in endoscopy training. Because these changes are so small, teaching endoscopy in blocks is probably adequate, if necessary to balance other clinical and research experience. However, further research is needed to determine whether a longitudinal endoscopy experience is superior for attaining and maintaining competency, to evaluate the effects of breaks longer than 8 weeks, and to determine whether the effects of breaks depend on the previous volume of experience with colonoscopy.

Jumbo forceps are superior to standard large-capacity forceps in obtaining diagnostically adequate inflammatory bowel disease surveillance biopsy specimens.

BACKGROUND: In inflammatory bowel disease (IBD) surveillance colonoscopy, an increased number of biopsy specimens correlates with a higher dysplasia detection rate. Larger biopsy specimens may also increase the diagnostic yield. OBJECTIVE: To compare a new jumbo forceps with a standard large-capacity forceps in obtaining diagnostically adequate IBD surveillance biopsy specimens. DESIGN: Prospective single-center study. PATIENTS AND METHODS: Twenty-four patients who were undergoing an IBD surveillance colonoscopy were enrolled. As part of standard IBD surveillance, 8 paired biopsy specimens were obtained from the rectosigmoid by using the jumbo forceps and a standard large-capacity forceps. OUTCOME MEASUREMENTS: Biopsy specimens were deemed adequate if they met all 3 of the following criteria: (1) length > or =3 mm, (2) penetration into the muscularis mucosa, and (3) < 20% crush artifact. RESULTS: The proportion of adequate biopsy specimens obtained with the jumbo forceps was significantly higher than that obtained with the large-capacity control forceps (67% vs 48%, P < .0001). The average length of the biopsy specimen obtained with the jumbo forceps was 4.00 mm (95% CI, 3.81-4.20 mm) compared with 3.19 mm (95% CI, 2.99-3.38 mm) with the large-capacity (control) forceps. LIMITATIONS: (1) No validated outcome measurement for the quality of GI biopsy specimens exists and (2) in this study, interobserver variability between pathologists was high. CONCLUSIONS: The jumbo forceps was superior to a standard large-capacity forceps in obtaining diagnostically adequate IBD surveillance biopsy specimens. Because biopsy specimens obtained with the jumbo forceps were larger, the use of this forceps for IBD surveillance will allow the endoscopist to sample a larger colonic mucosal surface area, potentially resulting in an increased dysplasia detection rate.