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Pilot study of aprepitant for prevention of post-ERCP pancreatitis in high risk patients: a phase II randomized, double-blind placebo controlled trial.

ABSTRACT: Animal studies have demonstrated a role for substance P binding to neurokinin-1 receptor in the pathogenesis of acute pancreatitis.Our aim was to assess the efficacy of a neurokinin-1 receptor antagonist (aprepitant) at preventing post-ERCP pancreatitis in high risk patients.Randomized, double-blind, placebo controlled trial at a single academic medical center.Patients at high risk for post-ERCP pancreatitis received either placebo or oral aprepitant administered 4 hours prior to ERCP, 80 mg 24 hours after the first dose, and then 80 mg 24 hours after the second dose.Thirty-four patients received aprepitant and 39 patients received placebo.Fisher's exact test was used to compare incidence of post-ERCP pancreatitis in the two groups.Baseline characteristics were similar between the two groups. Incidence of acute pancreatitis was 7 in the aprepitant group and 7 in the placebo group. Hospitalization within 7 days post-procedure for abdominal pain that did not meet criteria for acute pancreatitis occurred in 6 and 9 patients in the aprepitant and placebo groups respectively (P=0.772).Aprepitant did not lower incidence of post-ERCP pancreatitis in this preliminary human study. Larger studies potentially using the recently available intravenous formulation are necessary to conclusively clarify the efficacy of aprepitant in this setting.

SUBMITTER: Shah TU

PROVIDER: S-EPMC3736573 | biostudies-literature | 2012 Sep

REPOSITORIES: biostudies-literature

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Pilot study of aprepitant for prevention of post-ERCP pancreatitis in high risk patients: a phase II randomized, double-blind placebo controlled trial.

Shah Tilak Upendra TU Liddle Rodger R Branch M Stanley MS Jowell Paul P Obando Jorge J Poleski Martin M

JOP : Journal of the pancreas 20120910 5

<h4>Context</h4>Animal studies have demonstrated a role for substance P binding to neurokinin-1 receptor in the pathogenesis of acute pancreatitis.<h4>Objective</h4>Our aim was to assess the efficacy of a neurokinin-1 receptor antagonist (aprepitant) at preventing post-ERCP pancreatitis in high risk patients.<h4>Design</h4>Randomized, double-blind, placebo controlled trial at a single academic medical center.<h4>Intervention</h4>Patients at high risk for post-ERCP pancreatitis received either pl ...[more]

PMID: 22964958

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Project description:Background/aimsRecently the European Society of Gastrointestinal Endoscopy delivered guidelines on the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) and on the papillary cannulation and sphincterotomy techniques at endoscopic retrograde cholangiopancreatography (ERCP). There are no data concerning current practices in Portugal. The aim of this study was to capture practice patterns of Portuguese pancreaticobiliary endoscopists with special interest in the prevention of PEP and cannulation techniques.MethodsA written survey was distributed to all pancreaticobiliary endoscopists attending the first Portuguese meeting dedicated to ERCP in November 2016. The main outcome measures were: technique used for standard biliary cannulation, use of nonsteroidal anti-inflammatory drugs (NSAIDs) in PEP, attempting prophylactic pancreatic stenting after using pancreatic guidewire (PGW)-assisted biliary cannulation in patients where biliary cannulation was difficult, and use of precut as the first rescue technique when biliary cannulation was difficult.ResultsCompleted surveys were collected from 28 of the 32 pancreatobiliary endoscopists attending the meeting (answer rate 87.5%). Biliary cannulation was performed using a guidewire access technique by the majority (77%), usually with a sphincterotome. When cannulation was unsuccessful, precut was the first choice for 70%. NSAIDs were administered routinely for PEP by only 54%; PGW-assisted biliary cannulation was the first choice after failed standard cannulation for a minority of them, and only 27% reported to routinely attempt insertion of a pancreatic stent. High-volume endoscopists (> 150/year) tended to use NSAIDs and to insert a stent in PGW-assisted cannulation less often than low-volume-endoscopists (50 vs. 83.3%, p < 0.01, and 40 vs. 100%, p < 0.01, respectively). Precut was started without prior formal training by more than half of the endoscopists.ConclusionsThere is a pronounced discrepancy between evidence-based guidelines and current clinical practice. This discrepancy is more pronounced in PEP prophylaxis, especially among high-volume endoscopists. Some advanced techniques in ERCP are initiated unsupervised, without any previous formal training.Key messageThere is a significant gap between guidelines and routine clinical practice.

Project description:Previous human studies have shown low activity of protein C (APC) in severe acute pancreatitis (SAP). This, together with the findings in animal models, suggests that activated protein C (APC) may protect against pancreatic injury and ameliorate the disease. We, therefore, evaluated its effect on multiple organ dysfunction (MOD) measured by the SOFA (Sequential Organ Failure Assessment) and on organ-failure-free days, and the safety of APC in SAP.A prospective double blind randomized pilot study was use. The study occurred in one university hospital tertiary intensive care unit (ICU) with eight beds. The patients were chosen according to the following inclusion criteria: 1) Those admitted to the hospital < 96 h from the onset of pain, 2) Those who had a three-fold increase in serum amylase over normal upper range or/and in whom computed tomography (CT) verification of SAP was noted, 3) Those who had one or more organ dysfunction (OD), and 4) Those in whom less than 48 hours had passed since their first OD. Of a total of 215 adult patients with SAP screened between June 2003 and August 2007, 158 fulfilled the study inclusion criteria. After exclusions 32 patients were randomized to the study. The intervention consisted of APC (N = 16) administered intravenously for 96 hours with a dose of 24 ?g/kg/hour or placebo (N = 16) with a similar infusion rate. The sample size for the study was calculated according to the primary end-point: the change in SOFA during study drug infusion (Days 0 and 5). Comparisons between the study groups were performed using patient-related changes and calculation of difference in means (DIM, 95% CIs) and regarding categorical variables with Fisher's exact test. For all comparisons P < 0.05 was considered significant.No serious bleeding was detected clinically or by CT scans in either group. No significant difference in SOFA score change between the APC and placebo groups was found (difference in means (DIM) +2.3, 95% CI -0.7 to +5.3). Treatment with APC was associated with an increase in serum levels of both total and conjugated bilirubin. No differences in ventilator-free days, in renal replacement therapy-free days, in vasopressor-free days, or in days alive outside the hospital were detected.No serious bleeding or differences in the evolution of MOD were detected between APC and the placebo. Instead we found an increase in serum bilirubin in the APC group compared to the placebo group in patients with SAP.ClinicalTrials.gov NCT01017107.

Dataset Information

Pilot study of aprepitant for prevention of post-ERCP pancreatitis in high risk patients: a phase II randomized, double-blind placebo controlled trial.

Publications

Pilot study of aprepitant for prevention of post-ERCP pancreatitis in high risk patients: a phase II randomized, double-blind placebo controlled trial.

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