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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.
Am J Gastroenterol. 2013 Mar; 108(3):410-5.AJ

Abstract

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.

Authors+Show Affiliations

Division of Gastroenterology, University of Michigan Medical Center, Ann Arbor, Michigan 48109, USA. badihe@umich.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

23295278

Citation

Elmunzer, B Joseph, et al. "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." The American Journal of Gastroenterology, vol. 108, no. 3, 2013, pp. 410-5.
Elmunzer BJ, Higgins PD, Saini SD, et al. 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. Am J Gastroenterol. 2013;108(3):410-5.
Elmunzer, B. J., Higgins, P. D., Saini, S. D., Scheiman, J. M., Parker, R. A., Chak, A., Romagnuolo, J., Mosler, P., Hayward, R. A., Elta, G. H., Korsnes, S. J., Schmidt, S. E., Sherman, S., Lehman, G. A., & Fogel, E. L. (2013). 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. The American Journal of Gastroenterology, 108(3), 410-5. https://doi.org/10.1038/ajg.2012.442
Elmunzer BJ, et al. 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. Am J Gastroenterol. 2013;108(3):410-5. PubMed PMID: 23295278.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Elmunzer,B Joseph, AU - Higgins,Peter D R, AU - Saini,Sameer D, AU - Scheiman,James M, AU - Parker,Robert A, AU - Chak,Amitabh, AU - Romagnuolo,Joseph, AU - Mosler,Patrick, AU - Hayward,Rodney A, AU - Elta,Grace H, AU - Korsnes,Sheryl J, AU - Schmidt,Suzette E, AU - Sherman,Stuart, AU - Lehman,Glen A, AU - Fogel,Evan L, AU - ,, Y1 - 2013/01/08/ PY - 2013/1/9/entrez PY - 2013/1/9/pubmed PY - 2013/5/22/medline SP - 410 EP - 5 JF - The American journal of gastroenterology JO - Am J Gastroenterol VL - 108 IS - 3 N2 - 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. SN - 1572-0241 UR - https://www.unboundmedicine.com/medline/citation/23295278/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_ L2 - https://Insights.ovid.com/pubmed?pmid=23295278 DB - PRIME DP - Unbound Medicine ER -