Efficacy of diclofenac in the prevention of post-ERCP pancreatitis in predominantly high-risk patients: a randomized double-blind prospective trial

Young Koog Cheon, Kwang Bum Cho, James L. Watkins, Lee McHenry, Evan Fogel, Stuart Sherman, Suzette Schmidt, Laura Lazzell-Pannell, Glen Lehman

Research output: Contribution to journalArticle

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Abstract

Background: Pancreatitis is one of the major complications of ERCP and endoscopic sphincterotomy. It has been shown that nonsteriodal anti-inflammatory drugs are potent inhibitors of phospholipase A2, activity which is increased in pancreatitis. A previous study showed reduction of post-ERCP pancreatitis with administration of rectal diclofenac. Objective: The aim of this study was to determine whether prophylactic oral diclofenac will reduce the incidence and the severity of ERCP-induced pancreatitis, especially in high-risk patients. Design: Single-center, randomized, double-blinded, prospective study. Setting: Indiana University Medical Center. Patients: A total of 207 evaluable patients were randomized to receive either diclofenac 50 mg or placebo by mouth 30 to 90 minutes before and 4 to 6 hours after ERCP. Results: The groups were similar with regard to patient demographics and to patient and procedure risk factors for post-ERCP pancreatitis. The overall incidence of post-ERCP pancreatitis was 16.4%. It occurred in 17 of 102 patients in the control group (16.7%) and in 17 of 105 patients in diclofenac group (16.2%). The pancreatitis was graded mild in 9.8%, moderate in 5.9%, and severe 1.0% of the control group, and mild in 10.5%, moderate in 4.8%, and severe in 1.0% of the diclofenac group. In high-risk patients, the incidence of post-ERCP pancreatitis was 17.3%. It occurred in 18.0% (16/89) in the control group and in 17.8% (16/90) in the diclofenac group. There was no significant difference between the groups in the frequency or severity of post-ERCP pancreatitis in overall and high-risk patients; however, the power of the study was less than 45%. Conclusions: Prophylactic orally administered diclofenac was not observed to affect the frequency or severity of post-ERCP pancreatitis in high-risk patients.

Original languageEnglish
Pages (from-to)1126-1132
Number of pages7
JournalGastrointestinal Endoscopy
Volume66
Issue number6
DOIs
StatePublished - Dec 2007

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Diclofenac
Endoscopic Retrograde Cholangiopancreatography
Pancreatitis
Control Groups
Incidence
Phospholipase A2 Inhibitors
Rectal Administration
Endoscopic Sphincterotomy
Mouth
Anti-Inflammatory Agents
Placebos
Demography
Prospective Studies

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Efficacy of diclofenac in the prevention of post-ERCP pancreatitis in predominantly high-risk patients : a randomized double-blind prospective trial. / Cheon, Young Koog; Cho, Kwang Bum; Watkins, James L.; McHenry, Lee; Fogel, Evan; Sherman, Stuart; Schmidt, Suzette; Lazzell-Pannell, Laura; Lehman, Glen.

In: Gastrointestinal Endoscopy, Vol. 66, No. 6, 12.2007, p. 1126-1132.

Research output: Contribution to journalArticle

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abstract = "Background: Pancreatitis is one of the major complications of ERCP and endoscopic sphincterotomy. It has been shown that nonsteriodal anti-inflammatory drugs are potent inhibitors of phospholipase A2, activity which is increased in pancreatitis. A previous study showed reduction of post-ERCP pancreatitis with administration of rectal diclofenac. Objective: The aim of this study was to determine whether prophylactic oral diclofenac will reduce the incidence and the severity of ERCP-induced pancreatitis, especially in high-risk patients. Design: Single-center, randomized, double-blinded, prospective study. Setting: Indiana University Medical Center. Patients: A total of 207 evaluable patients were randomized to receive either diclofenac 50 mg or placebo by mouth 30 to 90 minutes before and 4 to 6 hours after ERCP. Results: The groups were similar with regard to patient demographics and to patient and procedure risk factors for post-ERCP pancreatitis. The overall incidence of post-ERCP pancreatitis was 16.4{\%}. It occurred in 17 of 102 patients in the control group (16.7{\%}) and in 17 of 105 patients in diclofenac group (16.2{\%}). The pancreatitis was graded mild in 9.8{\%}, moderate in 5.9{\%}, and severe 1.0{\%} of the control group, and mild in 10.5{\%}, moderate in 4.8{\%}, and severe in 1.0{\%} of the diclofenac group. In high-risk patients, the incidence of post-ERCP pancreatitis was 17.3{\%}. It occurred in 18.0{\%} (16/89) in the control group and in 17.8{\%} (16/90) in the diclofenac group. There was no significant difference between the groups in the frequency or severity of post-ERCP pancreatitis in overall and high-risk patients; however, the power of the study was less than 45{\%}. Conclusions: Prophylactic orally administered diclofenac was not observed to affect the frequency or severity of post-ERCP pancreatitis in high-risk patients.",
author = "Cheon, {Young Koog} and Cho, {Kwang Bum} and Watkins, {James L.} and Lee McHenry and Evan Fogel and Stuart Sherman and Suzette Schmidt and Laura Lazzell-Pannell and Glen Lehman",
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T2 - a randomized double-blind prospective trial

AU - Cheon, Young Koog

AU - Cho, Kwang Bum

AU - Watkins, James L.

AU - McHenry, Lee

AU - Fogel, Evan

AU - Sherman, Stuart

AU - Schmidt, Suzette

AU - Lazzell-Pannell, Laura

AU - Lehman, Glen

PY - 2007/12

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N2 - Background: Pancreatitis is one of the major complications of ERCP and endoscopic sphincterotomy. It has been shown that nonsteriodal anti-inflammatory drugs are potent inhibitors of phospholipase A2, activity which is increased in pancreatitis. A previous study showed reduction of post-ERCP pancreatitis with administration of rectal diclofenac. Objective: The aim of this study was to determine whether prophylactic oral diclofenac will reduce the incidence and the severity of ERCP-induced pancreatitis, especially in high-risk patients. Design: Single-center, randomized, double-blinded, prospective study. Setting: Indiana University Medical Center. Patients: A total of 207 evaluable patients were randomized to receive either diclofenac 50 mg or placebo by mouth 30 to 90 minutes before and 4 to 6 hours after ERCP. Results: The groups were similar with regard to patient demographics and to patient and procedure risk factors for post-ERCP pancreatitis. The overall incidence of post-ERCP pancreatitis was 16.4%. It occurred in 17 of 102 patients in the control group (16.7%) and in 17 of 105 patients in diclofenac group (16.2%). The pancreatitis was graded mild in 9.8%, moderate in 5.9%, and severe 1.0% of the control group, and mild in 10.5%, moderate in 4.8%, and severe in 1.0% of the diclofenac group. In high-risk patients, the incidence of post-ERCP pancreatitis was 17.3%. It occurred in 18.0% (16/89) in the control group and in 17.8% (16/90) in the diclofenac group. There was no significant difference between the groups in the frequency or severity of post-ERCP pancreatitis in overall and high-risk patients; however, the power of the study was less than 45%. Conclusions: Prophylactic orally administered diclofenac was not observed to affect the frequency or severity of post-ERCP pancreatitis in high-risk patients.

AB - Background: Pancreatitis is one of the major complications of ERCP and endoscopic sphincterotomy. It has been shown that nonsteriodal anti-inflammatory drugs are potent inhibitors of phospholipase A2, activity which is increased in pancreatitis. A previous study showed reduction of post-ERCP pancreatitis with administration of rectal diclofenac. Objective: The aim of this study was to determine whether prophylactic oral diclofenac will reduce the incidence and the severity of ERCP-induced pancreatitis, especially in high-risk patients. Design: Single-center, randomized, double-blinded, prospective study. Setting: Indiana University Medical Center. Patients: A total of 207 evaluable patients were randomized to receive either diclofenac 50 mg or placebo by mouth 30 to 90 minutes before and 4 to 6 hours after ERCP. Results: The groups were similar with regard to patient demographics and to patient and procedure risk factors for post-ERCP pancreatitis. The overall incidence of post-ERCP pancreatitis was 16.4%. It occurred in 17 of 102 patients in the control group (16.7%) and in 17 of 105 patients in diclofenac group (16.2%). The pancreatitis was graded mild in 9.8%, moderate in 5.9%, and severe 1.0% of the control group, and mild in 10.5%, moderate in 4.8%, and severe in 1.0% of the diclofenac group. In high-risk patients, the incidence of post-ERCP pancreatitis was 17.3%. It occurred in 18.0% (16/89) in the control group and in 17.8% (16/90) in the diclofenac group. There was no significant difference between the groups in the frequency or severity of post-ERCP pancreatitis in overall and high-risk patients; however, the power of the study was less than 45%. Conclusions: Prophylactic orally administered diclofenac was not observed to affect the frequency or severity of post-ERCP pancreatitis in high-risk patients.

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