Title: prospective, randomized, placebo controlled, phase III trial to evaluate the efficacy of magnesium sulfate for the prevention of post-ERCP pancreatitis~Study drug: Magnesium sulfate~Indication: post-ERCP pancreatitis~Study design: multi-centre, randomized, phase III, double blind, placebo controlled, parallel group~Patient population: adult patients with a medical indication for ERCP~Number of patients: 1376 randomized to two equal groups~Treatment: patients receive 2 infusions of 500 ml NaCl 0,9%: the first one 60 min before ERCP and the second one 6 hours after ERCP. To the infusions 10 ml of either magnesium sulfate or placebo (NaCl 0,9%) will be added.
MagPEP is a multi-centre, randomized, phase III, double blind, placebo controlled, parallel group trial. It evaluates magnesium sulfate for the prevention of post-ERCP pancreatitis. Adult patients with a medical indication for ERCP are to be randomized (1:1 ratio) to receive either magnesium sulfate or placebo (NaCl 0,9%) 60 min before and 6 hours after ERCP.