Pre-Study protocol MagPEP: a multicentre randomized controlled trial of magnesium sulphate in the prevention of post-ERCP pancreatitis
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- 作者：Gabriele Fluhr (1)
Julia Mayerle (1)
Eckhard Weber (1)
Ali Aghdassi (1)
Peter Simon (1)
Thomas Gress (2)
Thomas Seufferlein (3)
Joachim M?ssner (4)
Andreas Stallmach (5)
Thomas R?sch (6)
Martina Müller (7)
Britta Siegmund (8)
Petra Büchner-Steudel (9)
Ina Zuber-Jerger (7)
Marcus Kantowski (5)
Albrecht Hoffmeister (4)
Jonas Rosendahl (4)
Thomas Linhart (2)
Jochen Maul (8)
László Czakó (10)
Péter Hegyi (10)
Matthias Kraft (1)
Georg Engel (11)
Thomas Kohlmann (12)
Anne Glitsch (13)
Tilman Pickartz (1)
Christoph Budde (1)
Claudia Nitsche (1)
Kirsten Storck (1)
Markus M Lerch (1) - 刊名：BMC Gastroenterology
- 出版年：2013
- 出版时间：December 2013
- 年：2013
- 卷：13
- 期：1
- 全文大小：304KB
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25. The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-230X/13/11/prepub - 作者单位：Gabriele Fluhr (1)
Julia Mayerle (1)
Eckhard Weber (1)
Ali Aghdassi (1)
Peter Simon (1)
Thomas Gress (2)
Thomas Seufferlein (3)
Joachim M?ssner (4)
Andreas Stallmach (5)
Thomas R?sch (6)
Martina Müller (7)
Britta Siegmund (8)
Petra Büchner-Steudel (9)
Ina Zuber-Jerger (7)
Marcus Kantowski (5)
Albrecht Hoffmeister (4)
Jonas Rosendahl (4)
Thomas Linhart (2)
Jochen Maul (8)
László Czakó (10)
Péter Hegyi (10)
Matthias Kraft (1)
Georg Engel (11)
Thomas Kohlmann (12)
Anne Glitsch (13)
Tilman Pickartz (1)
Christoph Budde (1)
Claudia Nitsche (1)
Kirsten Storck (1)
Markus M Lerch (1)
1. Central Endoscopy and Department of Medicine A, University Medicine Greifswald, Ferdinand-Sauerbruch-Stra?e, Greifswald, 17475, Germany
2. Division of Gastroenterology, Endocrinology and Metabolism, Department of Medicine, Philipps-Universit?t Marburg, Baldingerstra?e, Marburg, 35043, Germany
3. Department of Medicine I, University Hospital Ulm, Albert-Einstein-Allee 23, Ulm, 89070, Germany
4. Division of Gastroenterology and Rheumatology, Department of Medicine, Neurology and Dermatology, University Hospital Leipzig A?R, Liebigstr. 20, Leipzig, 04103, Germany
5. Division of Gastroenterology, Hepatology and Infectious Diseases, Department of Medicine II, University Hospital Jena, Erlanger Allee 101, Jena, 07743, Germany
6. Department of Interdisciplinary Endoscopy, University Hospital Eppendorf, Martinistr. 52, Hamburg, 20246, Germany
7. Department of Internal Medicine I, University Hospital Regensburg, Franz-Joseph-Strau?-Allee 11, Regensburg, 93042, Germany
8. Department for Gastroenterology, Infectious Diseases and Rheumatology, Charité -University Medicine, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany
9. Department of Medicine I, University Hospital Halle, Ernst-Grube-Str. 40, Halle, 06120, Germany
10. First Department of Medicine, University of Szeged, 6701 Szeged, P.O.Box: 427, Szeged, Hungary
11. University Pharmacy, University Medicine Greifswald, Friedrich-Ludwig-Jahn-Stra?e 20, Greifswald, 17475, Germany
12. Department of Methods in Community Medicinem Institute for Community Medicine, University Medicine Greifswald, Walther-Rathenau-Str, Greifswald, 4817475, Germany
13. Central Endoscopy and Department of Surgery, University Medicine Greifswald, Ferdinand-Sauerbruch-Stra?e, Greifswald, 17475, Germany
文摘
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