Abstract
BackgroundAcute 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.MethodsWe 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.ConclusionsIf 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 registrationCurrent Controlled Trials ISRCTN46556454
Highlights
Acute pancreatitis is the most common complication of diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (ERCP)
The trial is sponsored by the University Hospital Greifswald, represented by the CEO, and the Deutsche Forschungsgemeinschaft (DFG), neither of which is involved in the database management or has access to the randomisation code
We report the protocol of a prospective randomized controlled trial to study the effectiveness of magnesium sulphate in the prevention of post-ERCP pancreatitis, the most important complication of diagnostic and therapeutic ERCP
Summary
Acute pancreatitis is the most common complication of diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (ERCP). 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. Endoscopic retrograde cholangiopancreatography (ERCP) is a common procedure employed to treat disorders of the biliary tract or the pancreas. In Germany around 124.000 ERCP’s (OPS 1–64, diagnostic ERC, ERP or ERCP) are performed annually (German federal statistics bureau for 2009). When an average rate of 5% is assumed, 6200 pancreatitis cases in Germany would be triggered by prior ERCP and 12% of the total 53.338 in-hospital pancreatitis cases in the country (German federal statistics bureau for 2009). The national in-hospital mortality for acute pancreatitis is 2.9% in Germany and ERCPinduced pancreatitis would account for at least 180 deaths
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