title: Pre-study protocol MagPEP: a multicentre randomized controlled trial of magnesium sulphate in the prevention of post-ERCP pancreatitis.
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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN46556454.
authors: Central Endoscopy and Department of Medicine A, University Medicine Greifswald, Ferdinand-Sauerbruch-Straße, Greifswald, 17475, Germany.
authors: Gabriele
authors: G
authors: Fluhr
authors: Julia
authors: J
authors: Mayerle
authors: Eckhard
authors: E
authors: Weber
authors: Ali
authors: A
authors: Aghdassi
authors: Peter
authors: P
authors: Simon
authors: Thomas
authors: T
authors: Gress
authors: Thomas
authors: T
authors: Seufferlein
authors: Joachim
authors: J
authors: Mössner
authors: Andreas
authors: A
authors: Stallmach
authors: Thomas
authors: T
authors: Rösch
authors: Martina
authors: M
authors: Müller
authors: Britta
authors: B
authors: Siegmund
authors: Petra
authors: P
authors: Büchner-Steudel
authors: Ina
authors: I
authors: Zuber-Jerger
authors: Marcus
authors: M
authors: Kantowski
authors: Albrecht
authors: A
authors: Hoffmeister
authors: Jonas
authors: J
authors: Rosendahl
authors: Thomas
authors: T
authors: Linhart
authors: Jochen
authors: J
authors: Maul
authors: László
authors: L
authors: Czakó
authors: Péter
authors: P
authors: Hegyi
authors: Matthias
authors: M
authors: Kraft
authors: Georg
authors: G
authors: Engel
authors: Thomas
authors: T
authors: Kohlmann
authors: Anne
authors: A
authors: Glitsch
authors: Tilman
authors: T
authors: Pickartz
authors: Christoph
authors: C
authors: Budde
authors: Claudia
authors: C
authors: Nitsche
authors: Kirsten
authors: K
authors: Storck
authors: Markus M
authors: MM
authors: Lerch
mesh_terms: D000208:Acute Disease; D061605:Administration, Intravenous; D000328:Adult; D020013:Calcium Signaling / Q000187:drug effects; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects*; D004311:Double-Blind Method; D006801:Humans; D015994:Incidence; D008278:Magnesium Sulfate / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D010195:Pancreatitis / Q000453:epidemiology / Q000209:etiology* / Q000517:prevention & control*; D012720:Severity of Illness Index
chemical_list: D008278:Magnesium Sulfate