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.

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.