Acute pancreatitis is the most frequent (5-10%) and severe complication after endoscopic retrograde cholangiopancreatography (ERCP), that could require of surgical intervention and lead to death. A double- blind study designed to evaluate if the treatment with somatostatin in intravenous bolus before starting the ERCP procedure followed by a continuous infusion for 4 hours after endoscopic proof could prevent acute post-ERCP pancreatitis. Patients submitted to ERCP will be randomized in two groups of treatment, one will receive somatostatin and another placebo. The main aim of this study will be the incidence of acute post-ERCP pancreatitis and secondary objectives will be identify sub-groups of patient with high risk to develop post-ERCP pancreatitis, who could benefit of pharmacologic prophylaxis before the exploration. The study will include 510 patients submitted to an ERCP during a period of 3 years.
A double- blind study designed to evaluate if the treatment with somatostatin in intravenous bolus before starting the ERCP procedure followed by a continuous infusion for 4 hours after endoscopic proof could prevent acute post-ERCP pancreatitis. Patients submitted to ERCP will be randomized in two groups of treatment, one will receive somatostatin and another placebo. The main aim of this study will be the incidence of acute post-ERCP pancreatitis and secondary objectives will be identify sub-groups of patient with high risk to develop post-ERCP pancreatitis, who could benefit of pharmacologic prophylaxis before the exploration. The study will include 510 patients submitted to an ERCP during a period of 3 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
510
250 microgramos bolus intravenous during 3 minutes and continuous infusion for 4 hours after endoscopic procedure
250 microgramos bolus intravenous in 3 minutes and continuous infusion for 4 hours after endoscopic
Intravenous bolus 250 micrograms
Endoscopy Unit Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
RECRUITINGHospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
RECRUITINGThe incidence of acute post-ERCP pancreatitis
Time frame: One week
Identify sub-groups of patients with high risk to develop post-ERCP pancreatitis
Time frame: One week
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