Pre-study protocol MagPEP: a multicentre randomized controlled trial of magnesium sulphate in the prevention of post-ERCP pancreatitis.

BACKGROUND: Acute pancreatitis is the most common complication of diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (ERCP). In spite of continuing research, no pharmacologic agent capable of effectively reducing the incidence of ERCP-induced pancreatitis has found its way into clinical practise. A number of experimental studies suggest that intrapancreatic calcium concentrations play an important role in the initiation of intracellular protease activation, an initiating step in the course of acute pancreatitis. Magnesium can act as a calcium-antagonist and counteracts effects in calcium signalling. It can thereby attenuate the intracellular activation of proteolytic digestive enzymes in the pancreas and reduces the severity of experimental pancreatitis when administered either intravenously or as a food supplement. METHODS: We designed a randomized, double-blind, placebo-controlled phase III study to test whether the administration of intravenous magnesium sulphate before and after ERCP reduces the incidence and the severity of post-ERCP pancreatitis. A total of 502 adult patients with a medical indication for ERCP are to be randomized to receive either 4930 mg magnesium sulphate (= 20 mmol magnesium) or placebo 60 min before and 6 hours after ERCP. The incidence of clinical post-ERCP pancreatitis, hyperlipasemia, pain levels, use of analgetics and length of hospital stay will be evaluated. CONCLUSIONS: If magnesium sulphate is found to be effective in preventing post-ERCP pancreatitis, this inexpensive agent with limited adverse effects could be used as a routine pharmacological prophylaxis. TRIAL REGISTRATION: Current Controlled Trials ISRCTN46556454.

Appropriateness of colonoscopy in the era of colorectal cancer screening: a prospective, multicenter study in a private-practice setting (Berlin Colonoscopy Project 1, BECOP 1).

PURPOSE: The introduction of reimbursement for screening colonoscopy in Germany more than one year ago raised concerns that the consequent workload might lead to underuse of diagnostic colonoscopy for symptomatic patients. Available appropriateness criteria for diagnostic colonoscopy have been rarely tested in a realistic outpatient setting. This study was designed to test current appropriateness criteria for diagnostic colonoscopy to better select patients and potentially provide more capacity for screening cases. Secondary goals were yield and quality control in both the diagnostic and screening cases. METHODS: A prospective study was initiated in 39 private-practice offices to collect data on consecutive colonoscopies conducted during a 6-day study period. A detailed questionnaire was developed to define indications and symptoms, and all findings at colonoscopy were recorded. Colonoscopies were further analyzed and stratified into a screening and a diagnostic group. In the diagnostic group, indications were assessed according to the current guidelines for appropriateness (American Society for Gastrointestinal Endoscopy, European Panel for the Appropriateness of Gastrointestinal Endoscopy), and the results were correlated with the percentage of relevant findings (tumors, inflammatory conditions). RESULTS: During the study period, 1,397 colonoscopies (57 percent screening, 43 percent diagnostic) were analyzed (male/female ratio = 39/61 percent; mean age, 61 years). Fourteen percent and 37 percent, respectively, of the 605 diagnostic colonoscopies were regarded as inappropriate relative to the criteria of the American Society for Gastrointestinal Endoscopy and the European Panel for the Appropriateness of Gastrointestinal Endoscopy. However, the percentage of relevant inflammatory and neoplastic findings (polyps, cancer, inflammatory bowel disease, benign strictures) was only 5 to 10 percent higher in the appropriate group than in the inappropriate group. On the basis of these data, a hypothetical model for selecting appropriate indications was developed: if patients older than aged 50 years with pain, bleeding, and diarrhea, but not constipation, are regarded as having an appropriate indication, such an approach would save 20 percent of colonoscopies in these main indication groups (bleeding, pain, diarrhea, constipation), with a hypothetical miss rate for relevant findings (as defined above) of 5 percent. CONCLUSIONS: Currently used appropriateness criteria for diagnostic colonoscopy increase the yield of relevant findings but lead to a miss rate for relevant findings in the range of 10 to 15 percent. Simple selection criteria based on age and symptoms could be more suitable and should be tested in a larger group of patients.