Rectal Indomethacin Does Not Prevent Post-ERCP Pancreatitis in Consecutive Patients.

BACKGROUND & AIMS: Rectal indomethacin, a nonsteroidal anti-inflammatory drug, is given to prevent pancreatitis in high-risk patients undergoing endoscopic retrograde cholangiopancreatography (ERCP), based on findings from clinical trials. The European Society for Gastrointestinal Endoscopy guidelines recently recommended prophylactic rectal indomethacin for all patients undergoing ERCP, including those at average risk for pancreatitis. We performed a randomized controlled trail to investigate the efficacy of this approach. METHODS: We performed a prospective, double-blind, placebo-controlled trial of 449 consecutive patients undergoing ERCP at Dartmouth Hitchcock Medical Center, from March 2013 through December 2014. Approximately 70% of the cohort were at average risk for PEP. Subjects were assigned randomly to groups given either a single 100-mg dose of rectal indomethacin (n = 223) or a placebo suppository (n = 226) during the procedure. The primary outcome was the development of post-ERCP pancreatitis (PEP), defined by new upper-abdominal pain, a lipase level more than 3-fold the upper limit of normal, and hospitalization after ERCP for 2 consecutive nights. RESULTS: There were no differences between the groups in baseline clinical or procedural characteristics. Sixteen patients in the indomethacin group (7.2%) and 11 in the placebo group (4.9%) developed PEP (P = .33). Complications and the severity of PEP were similar between groups. Per a priori protocol guidelines, the study was stopped owing to futility. CONCLUSIONS: In a randomized controlled study of consecutive patients undergoing ERCP, rectal indomethacin did not prevent post-ERCP pancreatitis. ClincialTrials.gov no: NCT01774604.

A quality improvement project significantly increased the vaccination rate for immunosuppressed patients with IBD.

BACKGROUND: Immunosuppressed patients with inflammatory bowel disease (IBD) are at risk for vaccine preventable illnesses. Our aim was to develop a quality improvement intervention to measure and improve the proportion of immunosuppressed IBD patients receiving recommended vaccinations. METHODS: Using a Plan-Do-Study-Act quality improvement model, a process was developed to improve the proportion of patients with immunosuppressed IBD receiving recommended vaccinations. A 1-page vaccine questionnaire was developed and distributed to consecutive patients being seen in the IBD clinic during influenza season. If recommended vaccines were due, patients were offered and given vaccines by a nurse at that visit. After a period of observation, a second Plan-Do-Study-Act was performed and processes were improved. Data were collected and analyzed using simple descriptive statistics, Pearson's chi-square, and analysis of means. RESULTS: Over a 10-week period, 184 patients were included in the intervention. Eighty-four of these patients (46%) were receiving immunosuppressant medications. Of these 84 patients, 45 (54%) had received an influenza vaccination in the previous year and 26 (31%) had received a pneumococcal vaccination within the previous 5 years. After the quality improvement intervention, the rate increased to 81% for influenza (P < 0.001) and 54% for pneumococcal vaccination (P < 0.001). An analysis of means confirms a significant change from the overall mean before and after the intervention. CONCLUSIONS: The vaccination rate for a high-risk IBD population was significantly improved using a quality improvement intervention. A similar approach can be taken for other processes associated with improved quality of care.

Cecal insertion and withdrawal times with wide-angle versus standard colonoscopes: a randomized controlled trial.

BACKGROUND & AIMS: The aim of this study was to see if a 170 degrees angle of view (wide angle [WA]) colonoscope allowed faster withdrawal without decreasing adenoma detection. METHODS: Eight colonoscopists at 2 institutions participated in the study. Patients were randomized so that each colonoscopist performed 50% of the exams with a 160 series (140 degrees angle of view; standard [ST]) colonoscope and 50% with a prototype 160 series colonoscope with a 170 degrees angle of view (WA instrument). Insertion and withdrawal times and number of polyps detected were recorded. Endoscopists were asked to withdraw as quickly as they could carefully complete the exams. Analysis of variance was done to compare insertion and withdrawal times and number of polyps detected. Time to perform biopsy, polypectomy, and cleaning was subtracted using a stopwatch. RESULTS: A total of 710 procedures were performed, 355 with ST and 355 with WA colonoscope. The mean insertion time was similar. The mean withdrawal time (absent time for suctioning, washing, etc.) with the WA colonoscope was 4.9 min which was shorter (4.9 vs 5.4 min; P = .0001) overall and for three individual endoscopists (P = .0001, P = .01, and P = .03). There was no difference in the mean number of adenomas detected per colonoscopy with ST (0.6) compared to WA (0.5) (P = .12). Two of the three endoscopists with shorter withdrawal times with WA had numerically higher detection rates with WA. CONCLUSIONS: The WA colonoscope is associated with a reduction in withdrawal time without compromising adenoma detection. However, this effect is operator dependent and the overall impact of wide-angle optics in this study was minor.

Risk of early surgery for Crohn's disease: implications for early treatment strategies.

OBJECTIVES: In this study we aimed to define the rate of early surgery for Crohn's disease and to identify risk factors associated with early surgery as a basis for subsequent studies of early intervention in Crohn's disease. METHODS: We assembled a retrospective cohort of patients with Crohn's disease diagnosed between 1991 and 1997 and followed for at least 3 yr, who were identified in 16 community and referral-based practices in New England. Chart review was performed for each patient. Details of baseline demographic and disease features were recorded. Surgical history including date of surgery, indication, and procedure were also noted. Risk factors for early surgery (defined as major surgery for Crohn's disease within 3 yr of diagnosis, exclusive of major surgery at time of diagnosis) were identified by univariate analysis. Multiple logistic regression was used to identify independent risk factors. RESULTS: Of 345 eligible patients, 69 (20.1%) required surgery within 3 yr of diagnosis, excluding the 14 patients (4.1%) who had major surgery at the time of diagnosis. Overall, the interval between diagnosis and surgery was short; one half of all patients who required surgery underwent operation within 6 months of diagnosis. Risk factors identified by univariate analysis as significantly associated with early surgery included the following: smoking; disease of small bowel without colonic involvement; nausea and vomiting or abdominal pain on presentation; neutrophil count; and steroid use in the first 6 months. Disease localized to the colon only, blood in the stool, use of 5-aminosalicylate, and lymphocyte count were inversely associated with risk of early surgery. Logistic regression confirmed independent associations with smoking as a positive risk factor and involvement of colon without small bowel as a negative risk factor for early surgery. CONCLUSIONS: The rate of surgery is high in the first 3 yr after diagnosis of Crohn's disease, particularly in the first 6 months. These results suggest that improved risk stratification and potent therapies with rapid onset of action are needed to modify the natural history of Crohn's disease.

Lansoprazole-associated microscopic colitis: a case series.

Lansoprazole is a potent proton pump inhibitor that has been well tolerated with minimal serious adverse events. One of the most commonly reported side effects is diarrhea in 3-8% of study patients. During 1997, approximately 850 veterans at our institution had their proton pump inhibitor converted from omeprazole to lansoprazole because of a formulary change. A number of patients subsequently developed chronic watery diarrhea. While evaluating six of these patients, we discovered microscopic colitis that resolved with discontinuation of lansoprazole. The diarrhea was described as three to 10 loose, nonbloody bowel movements per day with some abdominal cramping. Colonoscopy in five patients and flexible sigmoidoscopy in one patient revealed normal colonic mucosa, but random biopsies all supported microscopic colitis (five cases of lymphocytic colitis and one case of collagenous colitis). Complete symptom resolution occurred in all patients within 4 to 10 days of discontinuing lansoprazole. In all patients, follow-up biopsies demonstrated normalization of the colonic histology. This is the first published case series of patients with microscopic colitis that correlated clinically and histologically with the initiation and discontinuation of lansoprazole.