Does prophylactic oral steroid administration reduce the frequency and severity of post-ERCP pancreatitis?

Randomized prospective multicenter study

Stuart Sherman, Glen Lehman, D. Earle, J. Watkins, I. Barnett, J. Johanson, M. Freeman, I. Geenen, M. Ryan, H. Parker, E. Lazaridis, Evan Fogel, J. Flueckiger, W. Silverman, K. Dua, G. Aliperti, P. Yakshe, M. Uzer, W. Jones, J. Goff

Research output: Contribution to journalArticle

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Abstract

Although ERCP provides a unique opportunity to administer prophylactic therapy to limit the incidence and severity of post-procedure pancreatitis, no agent thus far studied has been effective in this regard. By elevating the functional C-1-esterase inhibitor levels and inhibiting many of the events in the cascade of autodigestion, systemic corticosteroids may reduce the incidence of post-ERCP pancreatitis. The aim of this randomized, double blind, controlled trial was to determine whether prophylactic corticosteroids will reduce the frequency and severity of post-ERCP pancreatitis. METHODS: Patients were randomized to receive either oral prednisone (40 mg) or placebo 15 hours and 3 hours prior to ERCP. A 160 variable database was prospectively collected by 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 post-procedure pancreatitis (GI Endosc 1991;37:383). This is the interim analysis of nearly 50% of planned enrollment. RESULTS: PANCREATITIS SEVERITY Total with Therapy N Mild Moderate Severe pancreatitis Prednisone 464 49 (10.6%) 21 (4.5%) 3 (.6%) 73 (15.7%) Placebo 471 44 (9.3%) 17 (3.6%) 5 (1%) 66 (14.0%) p = .43 The groups were similar with regards to age, sex, body mass index (BMI), frequency of prior pancreatitis, type of procedure performed (diagnostic or therapeutic), difficulty of cannulation, frequency of precut sphincterotomy, pancreatic sphincterotomy, sphincter of Oddi (SO) dysfunction, SO manometry, pancreatic acinarization, chronic pancreatitis, number of pancreatic duct injections, and common bile duct diameter. CONCLUSIONS: 1) In this interim analysis, prophylactic oral corticosteroids was not shown to reduce the frequency or severity of post-ERCP pancreatitis. 2) The study is ongoing with planned enrollment of 1,000 patients into each intervention arm.

Original languageEnglish
JournalGastrointestinal Endoscopy
Volume45
Issue number4
StatePublished - 1997
Externally publishedYes

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Endoscopic Retrograde Cholangiopancreatography
Pancreatitis
Multicenter Studies
Oral Administration
Steroids
Prospective Studies
Sphincter of Oddi
Adrenal Cortex Hormones
Prednisone
Complement C1s
Sphincter of Oddi Dysfunction
Placebos
Pancreatic Ducts
Incidence
Manometry
Chronic Pancreatitis
Common Bile Duct
Therapeutics
Catheterization
Body Mass Index

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Does prophylactic oral steroid administration reduce the frequency and severity of post-ERCP pancreatitis? Randomized prospective multicenter study. / Sherman, Stuart; Lehman, Glen; Earle, D.; Watkins, J.; Barnett, I.; Johanson, J.; Freeman, M.; Geenen, I.; Ryan, M.; Parker, H.; Lazaridis, E.; Fogel, Evan; Flueckiger, J.; Silverman, W.; Dua, K.; Aliperti, G.; Yakshe, P.; Uzer, M.; Jones, W.; Goff, J.

In: Gastrointestinal Endoscopy, Vol. 45, No. 4, 1997.

Research output: Contribution to journalArticle

Sherman, S, Lehman, G, Earle, D, Watkins, J, Barnett, I, Johanson, J, Freeman, M, Geenen, I, Ryan, M, Parker, H, Lazaridis, E, Fogel, E, Flueckiger, J, Silverman, W, Dua, K, Aliperti, G, Yakshe, P, Uzer, M, Jones, W & Goff, J 1997, 'Does prophylactic oral steroid administration reduce the frequency and severity of post-ERCP pancreatitis? Randomized prospective multicenter study', Gastrointestinal Endoscopy, vol. 45, no. 4.
Sherman, Stuart ; Lehman, Glen ; Earle, D. ; Watkins, J. ; Barnett, I. ; Johanson, J. ; Freeman, M. ; Geenen, I. ; Ryan, M. ; Parker, H. ; Lazaridis, E. ; Fogel, Evan ; Flueckiger, J. ; Silverman, W. ; Dua, K. ; Aliperti, G. ; Yakshe, P. ; Uzer, M. ; Jones, W. ; Goff, J. / Does prophylactic oral steroid administration reduce the frequency and severity of post-ERCP pancreatitis? Randomized prospective multicenter study. In: Gastrointestinal Endoscopy. 1997 ; Vol. 45, No. 4.
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abstract = "Although ERCP provides a unique opportunity to administer prophylactic therapy to limit the incidence and severity of post-procedure pancreatitis, no agent thus far studied has been effective in this regard. By elevating the functional C-1-esterase inhibitor levels and inhibiting many of the events in the cascade of autodigestion, systemic corticosteroids may reduce the incidence of post-ERCP pancreatitis. The aim of this randomized, double blind, controlled trial was to determine whether prophylactic corticosteroids will reduce the frequency and severity of post-ERCP pancreatitis. METHODS: Patients were randomized to receive either oral prednisone (40 mg) or placebo 15 hours and 3 hours prior to ERCP. A 160 variable database was prospectively collected by 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 post-procedure pancreatitis (GI Endosc 1991;37:383). This is the interim analysis of nearly 50{\%} of planned enrollment. RESULTS: PANCREATITIS SEVERITY Total with Therapy N Mild Moderate Severe pancreatitis Prednisone 464 49 (10.6{\%}) 21 (4.5{\%}) 3 (.6{\%}) 73 (15.7{\%}) Placebo 471 44 (9.3{\%}) 17 (3.6{\%}) 5 (1{\%}) 66 (14.0{\%}) p = .43 The groups were similar with regards to age, sex, body mass index (BMI), frequency of prior pancreatitis, type of procedure performed (diagnostic or therapeutic), difficulty of cannulation, frequency of precut sphincterotomy, pancreatic sphincterotomy, sphincter of Oddi (SO) dysfunction, SO manometry, pancreatic acinarization, chronic pancreatitis, number of pancreatic duct injections, and common bile duct diameter. CONCLUSIONS: 1) In this interim analysis, prophylactic oral corticosteroids was not shown to reduce the frequency or severity of post-ERCP pancreatitis. 2) The study is ongoing with planned enrollment of 1,000 patients into each intervention arm.",
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T1 - Does prophylactic oral steroid administration reduce the frequency and severity of post-ERCP pancreatitis?

T2 - Randomized prospective multicenter study

AU - Sherman, Stuart

AU - Lehman, Glen

AU - Earle, D.

AU - Watkins, J.

AU - Barnett, I.

AU - Johanson, J.

AU - Freeman, M.

AU - Geenen, I.

AU - Ryan, M.

AU - Parker, H.

AU - Lazaridis, E.

AU - Fogel, Evan

AU - Flueckiger, J.

AU - Silverman, W.

AU - Dua, K.

AU - Aliperti, G.

AU - Yakshe, P.

AU - Uzer, M.

AU - Jones, W.

AU - Goff, J.

PY - 1997

Y1 - 1997

N2 - Although ERCP provides a unique opportunity to administer prophylactic therapy to limit the incidence and severity of post-procedure pancreatitis, no agent thus far studied has been effective in this regard. By elevating the functional C-1-esterase inhibitor levels and inhibiting many of the events in the cascade of autodigestion, systemic corticosteroids may reduce the incidence of post-ERCP pancreatitis. The aim of this randomized, double blind, controlled trial was to determine whether prophylactic corticosteroids will reduce the frequency and severity of post-ERCP pancreatitis. METHODS: Patients were randomized to receive either oral prednisone (40 mg) or placebo 15 hours and 3 hours prior to ERCP. A 160 variable database was prospectively collected by 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 post-procedure pancreatitis (GI Endosc 1991;37:383). This is the interim analysis of nearly 50% of planned enrollment. RESULTS: PANCREATITIS SEVERITY Total with Therapy N Mild Moderate Severe pancreatitis Prednisone 464 49 (10.6%) 21 (4.5%) 3 (.6%) 73 (15.7%) Placebo 471 44 (9.3%) 17 (3.6%) 5 (1%) 66 (14.0%) p = .43 The groups were similar with regards to age, sex, body mass index (BMI), frequency of prior pancreatitis, type of procedure performed (diagnostic or therapeutic), difficulty of cannulation, frequency of precut sphincterotomy, pancreatic sphincterotomy, sphincter of Oddi (SO) dysfunction, SO manometry, pancreatic acinarization, chronic pancreatitis, number of pancreatic duct injections, and common bile duct diameter. CONCLUSIONS: 1) In this interim analysis, prophylactic oral corticosteroids was not shown to reduce the frequency or severity of post-ERCP pancreatitis. 2) The study is ongoing with planned enrollment of 1,000 patients into each intervention arm.

AB - Although ERCP provides a unique opportunity to administer prophylactic therapy to limit the incidence and severity of post-procedure pancreatitis, no agent thus far studied has been effective in this regard. By elevating the functional C-1-esterase inhibitor levels and inhibiting many of the events in the cascade of autodigestion, systemic corticosteroids may reduce the incidence of post-ERCP pancreatitis. The aim of this randomized, double blind, controlled trial was to determine whether prophylactic corticosteroids will reduce the frequency and severity of post-ERCP pancreatitis. METHODS: Patients were randomized to receive either oral prednisone (40 mg) or placebo 15 hours and 3 hours prior to ERCP. A 160 variable database was prospectively collected by 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 post-procedure pancreatitis (GI Endosc 1991;37:383). This is the interim analysis of nearly 50% of planned enrollment. RESULTS: PANCREATITIS SEVERITY Total with Therapy N Mild Moderate Severe pancreatitis Prednisone 464 49 (10.6%) 21 (4.5%) 3 (.6%) 73 (15.7%) Placebo 471 44 (9.3%) 17 (3.6%) 5 (1%) 66 (14.0%) p = .43 The groups were similar with regards to age, sex, body mass index (BMI), frequency of prior pancreatitis, type of procedure performed (diagnostic or therapeutic), difficulty of cannulation, frequency of precut sphincterotomy, pancreatic sphincterotomy, sphincter of Oddi (SO) dysfunction, SO manometry, pancreatic acinarization, chronic pancreatitis, number of pancreatic duct injections, and common bile duct diameter. CONCLUSIONS: 1) In this interim analysis, prophylactic oral corticosteroids was not shown to reduce the frequency or severity of post-ERCP pancreatitis. 2) The study is ongoing with planned enrollment of 1,000 patients into each intervention arm.

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