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

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 Lehman, Evan Fogel

Research output: Contribution to journalArticle

62 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)410-415
Number of pages6
JournalAmerican Journal of Gastroenterology
Volume108
Issue number3
DOIs
StatePublished - Mar 2013

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Indomethacin
Cost-Benefit Analysis
Stents
Clinical Trials
Randomized Controlled Trials
Endoscopic Retrograde Cholangiopancreatography
Logistic Models
Economics
Rectal Administration
Costs and Cost Analysis
Cost Savings
Pancreatitis
Health Care Costs
Peptamen

ASJC Scopus subject areas

  • Gastroenterology

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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. / Elmunzer, B. Joseph; Higgins, Peter D R; Saini, Sameer D.; Scheiman, James M.; Parker, Robert A.; Chak, Amitabh; Romagnuolo, Joseph; Mosler, Patrick; Hayward, Rodney A.; Elta, Grace H.; Korsnes, Sheryl J.; Schmidt, Suzette E.; Sherman, Stuart; Lehman, Glen; Fogel, Evan.

In: American Journal of Gastroenterology, Vol. 108, No. 3, 03.2013, p. 410-415.

Research output: Contribution to journalArticle

Elmunzer, B. Joseph ; Higgins, Peter D R ; Saini, Sameer D. ; Scheiman, James M. ; Parker, Robert A. ; Chak, Amitabh ; Romagnuolo, Joseph ; Mosler, Patrick ; Hayward, Rodney A. ; Elta, Grace H. ; Korsnes, Sheryl J. ; Schmidt, Suzette E. ; Sherman, Stuart ; Lehman, Glen ; Fogel, Evan. / 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. In: American Journal of Gastroenterology. 2013 ; Vol. 108, No. 3. pp. 410-415.
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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.",
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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

AU - Fogel, Evan

PY - 2013/3

Y1 - 2013/3

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.

AB - 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.

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