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

Gabriele Fluhr, Julia Mayerle, Eckhard Weber, Ali Aghdassi, Peter Simon, Thomas Gress, Thomas Seufferlein, Joachim Mössner, Andreas Stallmach, Thomas Rösch, Martina Müller, Britta Siegmund, Petra Büchner-Steudel, Ina Zuber-Jerger, Marcus Kantowski, Albrecht Hoffmeister, Jonas Rosendahl, Thomas Linhart, Jochen Maul, László Czakó, Péter Hegyi, Matthias Kraft, Georg Engel, Thomas Kohlmann, Anne Glitsch, Tilman Pickartz, Christoph Budde, Claudia Nitsche, Kirsten Storck, Markus M Lerch, Gabriele Fluhr, Julia Mayerle, Eckhard Weber, Ali Aghdassi, Peter Simon, Thomas Gress, Thomas Seufferlein, Joachim Mössner, Andreas Stallmach, Thomas Rösch, Martina Müller, Britta Siegmund, Petra Büchner-Steudel, Ina Zuber-Jerger, Marcus Kantowski, Albrecht Hoffmeister, Jonas Rosendahl, Thomas Linhart, Jochen Maul, László Czakó, Péter Hegyi, Matthias Kraft, Georg Engel, Thomas Kohlmann, Anne Glitsch, Tilman Pickartz, Christoph Budde, Claudia Nitsche, Kirsten Storck, Markus M Lerch

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.

Figures

Figure 1
Figure 1
Randomization and treatment flow chart of the study.

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