| Does Rectal Indomethacin Eliminate the Need for Prophylactic Pancreatic Stent Placement in Patients Undergoing High-Risk ERCP? Post hoc Efficacy and Cost-Benefit Analyses Using Prospective Clinical Trial Data. | |
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MedLine Citation:
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PMID: 23295278 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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OBJECTIVES:A recent large-scale randomized controlled trial (RCT) demonstrated that rectal indomethacin administration is effective in addition to pancreatic stent placement (PSP) for preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in high-risk cases. We performed a post hoc analysis of this RCT to explore whether rectal indomethacin can replace PSP in the prevention of PEP and to estimate the potential cost savings of such an approach.METHODS:We retrospectively classified RCT subjects into four prevention groups: (1) no prophylaxis, (2) PSP alone, (3) rectal indomethacin alone, and (4) the combination of PSP and indomethacin. Multivariable logistic regression was used to adjust for imbalances in the prevalence of risk factors for PEP between the groups. Based on these adjusted PEP rates, we conducted an economic analysis comparing the costs associated with PEP prevention strategies employing rectal indomethacin alone, PSP alone, or the combination of both.RESULTS:After adjusting for risk using two different logistic regression models, rectal indomethacin alone appeared to be more effective for preventing PEP than no prophylaxis, PSP alone, and the combination of indomethacin and PSP. Economic analysis revealed that indomethacin alone was a cost-saving strategy in 96% of Monte Carlo trials. A prevention strategy employing rectal indomethacin alone could save approximately $150 million annually in the United States compared with a strategy of PSP alone, and $85 million compared with a strategy of indomethacin and PSP.CONCLUSIONS:This hypothesis-generating study suggests that prophylactic rectal indomethacin could replace PSP in patients undergoing high-risk ERCP, potentially improving clinical outcomes and reducing healthcare costs. A RCT comparing rectal indomethacin alone vs. indomethacin plus PSP is needed.Am J Gastroenterol advance online publication, 8 January 2013; doi:10.1038/ajg.2012.442. |
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Authors:
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B Joseph Elmunzer; Peter D R Higgins; Sameer D Saini; James M Scheiman; Robert A Parker; Amitabh Chak; Joseph Romagnuolo; Patrick Mosler; Rodney A Hayward; Grace H Elta; Sheryl J Korsnes; Suzette E Schmidt; Stuart Sherman; Glen A Lehman; Evan L Fogel |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2013-1-08 |
Journal Detail:
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Title: The American journal of gastroenterology Volume: - ISSN: 1572-0241 ISO Abbreviation: Am. J. Gastroenterol. Publication Date: 2013 Jan |
Date Detail:
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Created Date: 2013-1-8 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0421030 Medline TA: Am J Gastroenterol Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
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Division of Gastroenterology, University of Michigan Medical Center, Ann Arbor, Michigan, USA. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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