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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. TRIAL REGISTRATION:Current Controlled Trials ISRCTN46556454.

journal_name

BMC Gastroenterol

journal_title

BMC gastroenterology

authors

Fluhr G,Mayerle J,Weber E,Aghdassi A,Simon P,Gress T,Seufferlein T,Mössner J,Stallmach A,Rösch T,Müller M,Siegmund B,Büchner-Steudel P,Zuber-Jerger I,Kantowski M,Hoffmeister A,Rosendahl J,Linhart T,Maul J,Czakó L,

doi

10.1186/1471-230X-13-11

subject

Has Abstract

pub_date

2013-01-15 00:00:00

pages

issn

1471-230X

pii

1471-230X-13-11

journal_volume

pub_type

杂志文章,多中心研究,随机对照试验

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