Abstract
Considerable effort and resources have been expended in the last 3 decades on the study of pharmacoprevention for post–endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP), with limited success, in part because of inadequate sample sizes in randomized controlled trials (RCTs). For reference, an adequately powered RCT aiming to detect a 50% reduction in PEP from 10% to 5% requires approximately 950 subjects. 1 Elmunzer B.J. et al. N Engl J Med. 2012; 366: 1414-1422 Crossref PubMed Scopus (460) Google Scholar ,2 Fogel E.L. et al. Lancet Gastroenterol Hepatol. 2020; 5: 132-141 Abstract Full Text Full Text PDF PubMed Scopus (0) Google Scholar Because sample sizes of this magnitude for every potentially effective medication are impractical, a cogent framework for proof-of-concept (POC) studies to screen candidate agents is critical for drug development and repurposing.
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