Does prophylactic administration of corticosteroid reduce the risk and severity of post-ERCP pancreatitis: A randomized, prospective, multicenter study

Stuart Sherman, Urszula Blaut, James L. Watkins, Jeffrey Barnett, Martin Freeman, Joseph Geenen, Michael Ryan, Harrison Parker, James T. Frakes, Evan Fogel, William B. Silverman, Kulwinder S. Dua, Giuseppe Aliperti, Paul Yakshe, Michael Uzer, Whitney Jones, John Goff, Dee Earle, M'hamed Temkit, Glen Lehman

Research output: Contribution to journalArticle

62 Citations (Scopus)

Abstract

Background: Pancreatitis is the most common major complication of diagnostic and therapeutic ERCP. There have been continuing efforts to identify a pharmacologic agent capable of reducing the frequency and severity of this complication. On the basis of several case reports, experimental data, and knowledge of their mechanism of action, corticosteroids might be effective in this regard. The aim of this randomized, double-blind, controlled trial was to determine whether prophylactic, orally administered corticosteroid reduces the frequency and/or severity of post-ERCP pancreatitis. Methods: A total of 1115 patients were randomized to receive either prednisone (40 mg) or a placebo orally 15 hours and 3 hours before ERCP. A 160 variable database was prospectively collected according to a defined protocol on patients undergoing diagnostic or therapeutic ERCP at 15 centers in the Midwest Pancreaticobiliary Group. Standardized criteria were used to diagnose and grade the severity of postprocedure pancreatitis. Results: The overall frequency of pancreatitis was 15.07%. It occurred in 92 of 555 patients in the corticosteroid group (16.6%), and in 76 of 560 patients in the control group (13.6%; p = 0.19). The pancreatitis was mild in 10.04%, moderate in 4.04%, and severe in 0.99%. There was no difference between the groups with regard to the severity of pancreatitis. Moreover, the groups were similar with regard to age, gender, body mass index, frequency of prior pancreatitis, type of procedure performed (diagnostic or therapeutic), difficulty of cannulation, frequency of pre-cut sphincterotomy, pancreatic sphincterotomy, sphincter of Oddi dysfunction, sphincter of Oddi manometry, pancreatic acinarization, chronic pancreatitis, number of pancreatic duct injections, and bile duct diameter. Conclusion: Prophylactic orally administered corticosteroid did not reduce the frequency or severity of post-ERCP pancreatitis.

Original languageEnglish
Pages (from-to)23-29
Number of pages7
JournalGastrointestinal Endoscopy
Volume58
Issue number1
DOIs
StatePublished - Jul 2003

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Endoscopic Retrograde Cholangiopancreatography
Pancreatitis
Multicenter Studies
Adrenal Cortex Hormones
Prospective Studies
Sphincter of Oddi
Sphincter of Oddi Dysfunction
Pancreatic Ducts
Reducing Agents
Manometry
Chronic Pancreatitis
Prednisone
Bile Ducts
Catheterization
Body Mass Index
Therapeutics
Placebos
Databases
Control Groups
Injections

ASJC Scopus subject areas

  • Gastroenterology

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Does prophylactic administration of corticosteroid reduce the risk and severity of post-ERCP pancreatitis : A randomized, prospective, multicenter study. / Sherman, Stuart; Blaut, Urszula; Watkins, James L.; Barnett, Jeffrey; Freeman, Martin; Geenen, Joseph; Ryan, Michael; Parker, Harrison; Frakes, James T.; Fogel, Evan; Silverman, William B.; Dua, Kulwinder S.; Aliperti, Giuseppe; Yakshe, Paul; Uzer, Michael; Jones, Whitney; Goff, John; Earle, Dee; Temkit, M'hamed; Lehman, Glen.

In: Gastrointestinal Endoscopy, Vol. 58, No. 1, 07.2003, p. 23-29.

Research output: Contribution to journalArticle

Sherman, S, Blaut, U, Watkins, JL, Barnett, J, Freeman, M, Geenen, J, Ryan, M, Parker, H, Frakes, JT, Fogel, E, Silverman, WB, Dua, KS, Aliperti, G, Yakshe, P, Uzer, M, Jones, W, Goff, J, Earle, D, Temkit, M & Lehman, G 2003, 'Does prophylactic administration of corticosteroid reduce the risk and severity of post-ERCP pancreatitis: A randomized, prospective, multicenter study', Gastrointestinal Endoscopy, vol. 58, no. 1, pp. 23-29. https://doi.org/10.1067/mge.2003.307
Sherman, Stuart ; Blaut, Urszula ; Watkins, James L. ; Barnett, Jeffrey ; Freeman, Martin ; Geenen, Joseph ; Ryan, Michael ; Parker, Harrison ; Frakes, James T. ; Fogel, Evan ; Silverman, William B. ; Dua, Kulwinder S. ; Aliperti, Giuseppe ; Yakshe, Paul ; Uzer, Michael ; Jones, Whitney ; Goff, John ; Earle, Dee ; Temkit, M'hamed ; Lehman, Glen. / Does prophylactic administration of corticosteroid reduce the risk and severity of post-ERCP pancreatitis : A randomized, prospective, multicenter study. In: Gastrointestinal Endoscopy. 2003 ; Vol. 58, No. 1. pp. 23-29.
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abstract = "Background: Pancreatitis is the most common major complication of diagnostic and therapeutic ERCP. There have been continuing efforts to identify a pharmacologic agent capable of reducing the frequency and severity of this complication. On the basis of several case reports, experimental data, and knowledge of their mechanism of action, corticosteroids might be effective in this regard. The aim of this randomized, double-blind, controlled trial was to determine whether prophylactic, orally administered corticosteroid reduces the frequency and/or severity of post-ERCP pancreatitis. Methods: A total of 1115 patients were randomized to receive either prednisone (40 mg) or a placebo orally 15 hours and 3 hours before ERCP. A 160 variable database was prospectively collected according to a defined protocol on patients undergoing diagnostic or therapeutic ERCP at 15 centers in the Midwest Pancreaticobiliary Group. Standardized criteria were used to diagnose and grade the severity of postprocedure pancreatitis. Results: The overall frequency of pancreatitis was 15.07{\%}. It occurred in 92 of 555 patients in the corticosteroid group (16.6{\%}), and in 76 of 560 patients in the control group (13.6{\%}; p = 0.19). The pancreatitis was mild in 10.04{\%}, moderate in 4.04{\%}, and severe in 0.99{\%}. There was no difference between the groups with regard to the severity of pancreatitis. Moreover, the groups were similar with regard to age, gender, body mass index, frequency of prior pancreatitis, type of procedure performed (diagnostic or therapeutic), difficulty of cannulation, frequency of pre-cut sphincterotomy, pancreatic sphincterotomy, sphincter of Oddi dysfunction, sphincter of Oddi manometry, pancreatic acinarization, chronic pancreatitis, number of pancreatic duct injections, and bile duct diameter. Conclusion: Prophylactic orally administered corticosteroid did not reduce the frequency or severity of post-ERCP pancreatitis.",
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T1 - Does prophylactic administration of corticosteroid reduce the risk and severity of post-ERCP pancreatitis

T2 - A randomized, prospective, multicenter study

AU - Sherman, Stuart

AU - Blaut, Urszula

AU - Watkins, James L.

AU - Barnett, Jeffrey

AU - Freeman, Martin

AU - Geenen, Joseph

AU - Ryan, Michael

AU - Parker, Harrison

AU - Frakes, James T.

AU - Fogel, Evan

AU - Silverman, William B.

AU - Dua, Kulwinder S.

AU - Aliperti, Giuseppe

AU - Yakshe, Paul

AU - Uzer, Michael

AU - Jones, Whitney

AU - Goff, John

AU - Earle, Dee

AU - Temkit, M'hamed

AU - Lehman, Glen

PY - 2003/7

Y1 - 2003/7

N2 - Background: Pancreatitis is the most common major complication of diagnostic and therapeutic ERCP. There have been continuing efforts to identify a pharmacologic agent capable of reducing the frequency and severity of this complication. On the basis of several case reports, experimental data, and knowledge of their mechanism of action, corticosteroids might be effective in this regard. The aim of this randomized, double-blind, controlled trial was to determine whether prophylactic, orally administered corticosteroid reduces the frequency and/or severity of post-ERCP pancreatitis. Methods: A total of 1115 patients were randomized to receive either prednisone (40 mg) or a placebo orally 15 hours and 3 hours before ERCP. A 160 variable database was prospectively collected according to a defined protocol on patients undergoing diagnostic or therapeutic ERCP at 15 centers in the Midwest Pancreaticobiliary Group. Standardized criteria were used to diagnose and grade the severity of postprocedure pancreatitis. Results: The overall frequency of pancreatitis was 15.07%. It occurred in 92 of 555 patients in the corticosteroid group (16.6%), and in 76 of 560 patients in the control group (13.6%; p = 0.19). The pancreatitis was mild in 10.04%, moderate in 4.04%, and severe in 0.99%. There was no difference between the groups with regard to the severity of pancreatitis. Moreover, the groups were similar with regard to age, gender, body mass index, frequency of prior pancreatitis, type of procedure performed (diagnostic or therapeutic), difficulty of cannulation, frequency of pre-cut sphincterotomy, pancreatic sphincterotomy, sphincter of Oddi dysfunction, sphincter of Oddi manometry, pancreatic acinarization, chronic pancreatitis, number of pancreatic duct injections, and bile duct diameter. Conclusion: Prophylactic orally administered corticosteroid did not reduce the frequency or severity of post-ERCP pancreatitis.

AB - Background: Pancreatitis is the most common major complication of diagnostic and therapeutic ERCP. There have been continuing efforts to identify a pharmacologic agent capable of reducing the frequency and severity of this complication. On the basis of several case reports, experimental data, and knowledge of their mechanism of action, corticosteroids might be effective in this regard. The aim of this randomized, double-blind, controlled trial was to determine whether prophylactic, orally administered corticosteroid reduces the frequency and/or severity of post-ERCP pancreatitis. Methods: A total of 1115 patients were randomized to receive either prednisone (40 mg) or a placebo orally 15 hours and 3 hours before ERCP. A 160 variable database was prospectively collected according to a defined protocol on patients undergoing diagnostic or therapeutic ERCP at 15 centers in the Midwest Pancreaticobiliary Group. Standardized criteria were used to diagnose and grade the severity of postprocedure pancreatitis. Results: The overall frequency of pancreatitis was 15.07%. It occurred in 92 of 555 patients in the corticosteroid group (16.6%), and in 76 of 560 patients in the control group (13.6%; p = 0.19). The pancreatitis was mild in 10.04%, moderate in 4.04%, and severe in 0.99%. There was no difference between the groups with regard to the severity of pancreatitis. Moreover, the groups were similar with regard to age, gender, body mass index, frequency of prior pancreatitis, type of procedure performed (diagnostic or therapeutic), difficulty of cannulation, frequency of pre-cut sphincterotomy, pancreatic sphincterotomy, sphincter of Oddi dysfunction, sphincter of Oddi manometry, pancreatic acinarization, chronic pancreatitis, number of pancreatic duct injections, and bile duct diameter. Conclusion: Prophylactic orally administered corticosteroid did not reduce the frequency or severity of post-ERCP pancreatitis.

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