Literature DB >> 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.

B Joseph Elmunzer1, 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.   

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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Year:  2013        PMID: 23295278      PMCID: PMC3947644          DOI: 10.1038/ajg.2012.442

Source DB:  PubMed          Journal:  Am J Gastroenterol        ISSN: 0002-9270            Impact factor:   10.864


  21 in total

1.  Magnetic resonance cholangiopancreatography: a meta-analysis of test performance in suspected biliary disease.

Authors:  Joseph Romagnuolo; Marc Bardou; Elham Rahme; Lawrence Joseph; Caroline Reinhold; Alan N Barkun
Journal:  Ann Intern Med       Date:  2003-10-07       Impact factor: 25.391

Review 2.  Endoscopic sphincterotomy complications and their management: an attempt at consensus.

Authors:  P B Cotton; G Lehman; J Vennes; J E Geenen; R C Russell; W C Meyers; C Liguory; N Nickl
Journal:  Gastrointest Endosc       Date:  1991 May-Jun       Impact factor: 9.427

3.  A survey of physician practices on prophylactic pancreatic stents.

Authors:  Stephen Brackbill; Scott Young; Philip Schoenfeld; Grace Elta
Journal:  Gastrointest Endosc       Date:  2006-07       Impact factor: 9.427

4.  Sphincter of Oddi manometry: decreased risk of clinical pancreatitis with use of a modified aspirating catheter.

Authors:  S Sherman; F P Troiano; R H Hawes; G A Lehman
Journal:  Gastrointest Endosc       Date:  1990 Sep-Oct       Impact factor: 9.427

5.  Pancreatic-stent placement for prevention of post-ERCP pancreatitis: a cost-effectiveness analysis.

Authors:  Ananya Das; Pankaj Singh; Michael V Sivak; Amitabh Chak
Journal:  Gastrointest Endosc       Date:  2007-02-28       Impact factor: 9.427

6.  Trends in the utilization of endoscopic retrograde cholangiopancreatography (ERCP) in the United States.

Authors:  M Mazen Jamal; Eugene J Yoon; Altaf Saadi; Theodore Y Sy; Mehrtash Hashemzadeh
Journal:  Am J Gastroenterol       Date:  2007-03-23       Impact factor: 10.864

Review 7.  Pancreatic stents for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis.

Authors:  Martin L Freeman
Journal:  Clin Gastroenterol Hepatol       Date:  2007-11       Impact factor: 11.382

8.  Pancreatic stenting prevents pancreatitis after biliary sphincterotomy in patients with sphincter of Oddi dysfunction.

Authors:  P R Tarnasky; Y Y Palesch; J T Cunningham; P D Mauldin; P B Cotton; R H Hawes
Journal:  Gastroenterology       Date:  1998-12       Impact factor: 22.682

9.  Pancreatic stent insertion: consequences of failure and results of a modified technique to maximize success.

Authors:  Martin L Freeman; Carol Overby; Dongfeng Qi
Journal:  Gastrointest Endosc       Date:  2004-01       Impact factor: 9.427

Review 10.  Role of pancreatic stents in prevention of post-ERCP pancreatitis.

Authors:  Martin L Freeman
Journal:  JOP       Date:  2004-09-10
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  20 in total

1.  Quality indicators for ERCP.

Authors:  Douglas G Adler; John G Lieb; Jonathan Cohen; Irving M Pike; Walter G Park; Maged K Rizk; Mandeep S Sawhney; James M Scheiman; Nicholas J Shaheen; Stuart Sherman; Sachin Wani
Journal:  Am J Gastroenterol       Date:  2014-12-02       Impact factor: 10.864

Review 2.  How to measure quality in endoscopic retrograde cholangiopancreatography (ERCP).

Authors:  Alexander Krumov Katzarov; Zdravko Ivanov Dunkov; Ivan Popadiin; Krum Sotirov Katzarov
Journal:  Ann Transl Med       Date:  2018-07

3.  Impact of pancreatic stent caliber on post-endoscopic retrograde cholangiopancreatogram pancreatitis rates in patients with confirmed sphincter of Oddi dysfunction.

Authors:  Jayapal Ramesh; Hwasoon Kim; Kartika Reddy; Shyam Varadarajulu; C Mel Wilcox
Journal:  J Gastroenterol Hepatol       Date:  2014       Impact factor: 4.029

4.  Consideration of Clinical Context and Alternative Therapies in Aggressive Resuscitation for Prevention of Post-ERCP Pancreatitis.

Authors:  Anna E Phillips; Georgios I Papachristou; Adam Slivka
Journal:  J Clin Gastroenterol       Date:  2019-07       Impact factor: 3.062

5.  Risk Factors for Post-ERCP Pancreatitis in High-Risk Patients Receiving Post-procedure Rectal Indomethacin.

Authors:  Xiaoyu Kang; Liyue Zheng; Wei Zeng; Shengye Yang; Hao Sun; Rongchun Zhang; Xiangping Wang; Biaoluo Wang; Qin Tao; Shaowei Yao; Jie Chen; Yanglin Pan; Xuegang Guo
Journal:  J Gastrointest Surg       Date:  2018-07-06       Impact factor: 3.452

6.  Preventive effect of tacrolimus on patients with post-endoscopic retrograde cholangiopancreatography pancreatitis.

Authors:  Harshavardhan Rao B; Paul K Vincent; Priya Nair; Anoop K Koshy; Rama P Venu
Journal:  Clin Endosc       Date:  2022-08-02

Review 7.  Prevention of post-ERCP pancreatitis.

Authors:  Jennifer Maranki; Paul Yeaton
Journal:  Curr Gastroenterol Rep       Date:  2013-11

8.  Rectal Indomethacin Does Not Prevent Post-ERCP Pancreatitis in Consecutive Patients.

Authors:  John M Levenick; Stuart R Gordon; Linda L Fadden; L Campbell Levy; Matthew J Rockacy; Sarah M Hyder; Brian E Lacy; Steven P Bensen; Douglas D Parr; Timothy B Gardner
Journal:  Gastroenterology       Date:  2016-01-09       Impact factor: 22.682

Review 9.  Update on the Prevention of Post-ERCP Pancreatitis.

Authors:  Han Zhang; Jaehoon Cho; James Buxbaum
Journal:  Curr Treat Options Gastroenterol       Date:  2018-12

10.  Controversies in ERCP: Indications and preparation.

Authors:  Christoph F Dietrich; Noor L Bekkali; Sean Burmeister; Yi Dong; Simon M Everett; Michael Hocke; Andre Ignee; Wei On; Srisha Hebbar; Kofi Oppong; Siyu Sun; Christian Jenssen; Barbara Braden
Journal:  Endosc Ultrasound       Date:  2022 May-Jun       Impact factor: 5.275

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