Preferred designs, outcomes, and analysis strategies for treatment trials in idiopathic recurrent acute pancreatitis

Joseph Romagnuolo, Nalini Guda, Martin Freeman, Valerie Durkalski

Research output: Contribution to journalArticle

16 Scopus citations

Abstract

IRAP is a complicated area to study, and, in part, this is the reason there is a paucity of IRAP clinical trials. However, in reviewing the literature and weighing methodologic and statistical concerns, a time-to-event analysis of any recurrence of pancreatitis appears to be the most sound and practical end point for a prospective study. The preferred design would be a stratified (eg, single vs recurrent [or other dichotomy of baseline attack frequency] and/or a prior cholecystectomy versus no prior cholecystectomy) randomized controlled (preferably blinded) trial, likely of at least 3 years' duration, with a stratified time-to-event primary analysis. A multicenter registry (as is currently being developed by the IRAP Interest Group) may be able to answer some questions and has the possible advantage of efficiency in using a single patient for the assessment of more than one intervention but has a more complicated analysis and is prone to confounding by unknown confounders (which randomization is best to balance).

Original languageEnglish (US)
Pages (from-to)966-974
Number of pages9
JournalGastrointestinal endoscopy
Volume68
Issue number5
DOIs
StatePublished - Nov 1 2008

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