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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.

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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