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

Fluhr, Gabriele and Mayerle, Julia and Weber, Eckhard and Aghdassi, Ali and Simon, Peter and Gress, Thomas and Seufferlein, Thomas and Moessner, Joachim and Stallmach, Andreas and Roesch, Thomas and Mueller, Martina and Siegmund, Britta and Buechner-Steudel, Petra and Zuber-Jerger, Ina and Kantowski, Marcus and Hoffmeister, Albrecht and Rosendahl, Jonas and Linhart, Thomas and Maul, Jochen and Czako, Laszlo and Hegyi, Peter and Kraft, Matthias and Engel, Georg and Kohlmann, Thomas and Glitsch, Anne and Pickartz, Tilman and Budde, Christoph and Nitsche, Claudia and Storck, Kirsten and Lerch, Markus M. (2013) Pre-Study protocol MagPEP: a multicentre randomized controlled trial of magnesium sulphate in the prevention of post-ERCP pancreatitis. BMC GASTROENTEROLOGY, 13: 11. ISSN 1471-230X,

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Abstract

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

Item Type: Article
Uncontrolled Keywords: RETROGRADE CHOLANGIOPANCREATOGRAPHY PANCREATITIS; METAANALYSIS; SOMATOSTATIN; ALLOPURINOL; MANAGEMENT; GABEXATE; ONSET;
Subjects: 600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Lehrstuhl für Innere Medizin I
Depositing User: Dr. Gernot Deinzer
Date Deposited: 28 Apr 2020 07:21
Last Modified: 28 Apr 2020 07:21
URI: https://pred.uni-regensburg.de/id/eprint/17284

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