Pre-study protocol MagPEP
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Pre-study protocol MagPEP : a multicentre randomized controlled trial of magnesium sulphate in the prevention of post-ERCP pancreatitis. / Fluhr, Gabriele; Mayerle, Julia; Weber, Eckhard; Aghdassi, Ali; Simon, Peter; Gress, Thomas; Seufferlein, Thomas; Mössner, Joachim; Stallmach, Andreas; Rösch, Thomas; Müller, Martina; Siegmund, Britta; Büchner-Steudel, Petra; Zuber-Jerger, Ina; Kantowski, Marcus; Hoffmeister, Albrecht; Rosendahl, Jonas; Linhart, Thomas; Maul, Jochen; Czakó, László; Hegyi, Péter; Kraft, Matthias; Engel, Georg; Kohlmann, Thomas; Glitsch, Anne; Pickartz, Tilman; Budde, Christoph; Nitsche, Claudia; Storck, Kirsten; Lerch, Markus M.
in: BMC GASTROENTEROL, Jahrgang 13, 01.01.2013, S. 11.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Pre-study protocol MagPEP
T2 - a multicentre randomized controlled trial of magnesium sulphate in the prevention of post-ERCP pancreatitis
AU - Fluhr, Gabriele
AU - Mayerle, Julia
AU - Weber, Eckhard
AU - Aghdassi, Ali
AU - Simon, Peter
AU - Gress, Thomas
AU - Seufferlein, Thomas
AU - Mössner, Joachim
AU - Stallmach, Andreas
AU - Rösch, Thomas
AU - Müller, Martina
AU - Siegmund, Britta
AU - Büchner-Steudel, Petra
AU - Zuber-Jerger, Ina
AU - Kantowski, Marcus
AU - Hoffmeister, Albrecht
AU - Rosendahl, Jonas
AU - Linhart, Thomas
AU - Maul, Jochen
AU - Czakó, László
AU - Hegyi, Péter
AU - Kraft, Matthias
AU - Engel, Georg
AU - Kohlmann, Thomas
AU - Glitsch, Anne
AU - Pickartz, Tilman
AU - Budde, Christoph
AU - Nitsche, Claudia
AU - Storck, Kirsten
AU - Lerch, Markus M
PY - 2013/1/1
Y1 - 2013/1/1
N2 - 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.
AB - 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.
KW - Acute Disease
KW - Administration, Intravenous
KW - Adult
KW - Calcium Signaling
KW - Cholangiopancreatography, Endoscopic Retrograde
KW - Double-Blind Method
KW - Humans
KW - Incidence
KW - Magnesium Sulfate
KW - Pancreatitis
KW - Severity of Illness Index
U2 - 10.1186/1471-230X-13-11
DO - 10.1186/1471-230X-13-11
M3 - SCORING: Journal article
C2 - 23320650
VL - 13
SP - 11
JO - BMC GASTROENTEROL
JF - BMC GASTROENTEROL
SN - 1471-230X
ER -
