Abstract | BACKGROUND: 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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Authors | Young Koog Cheon, Kwang Bum Cho, James L Watkins, Lee McHenry, Evan L Fogel, Stuart Sherman, Suzette Schmidt, Laura Lazzell-Pannell, Glen A Lehman |
Journal | Gastrointestinal endoscopy
(Gastrointest Endosc)
Vol. 66
Issue 6
Pg. 1126-32
(Dec 2007)
ISSN: 0016-5107 [Print] United States |
PMID | 18061712
(Publication Type: Journal Article, Randomized Controlled Trial)
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Chemical References |
- Anti-Inflammatory Agents, Non-Steroidal
- Diclofenac
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Topics |
- Administration, Oral
- Anti-Inflammatory Agents, Non-Steroidal
(administration & dosage)
- Diclofenac
(administration & dosage)
- Double-Blind Method
- Female
- Humans
- Male
- Middle Aged
- Pancreatic Diseases
(diagnosis)
- Pancreatitis
(epidemiology, etiology, prevention & control)
- Primary Prevention
(methods)
- Prospective Studies
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