Intramuscular Diclofenac in the Prevention of Post-ERCP Pancreatitis

• Status: Completed
• Trial end date: 2013-08-28
• Target enrollment: 0
• Participant gender: All

Summary

Pancreatitis is one of the major complications of ERCP. It has been shown that NSAIDs are potent inhibitors of phospholipase A2, activity which is increased in pancreatitis. The only one study with IM diclofenac showed reduction of post-ERCP pancreatitis without SOD (sphincter of Oddi dysfunction) by subgroup analysis in small study population. Therefore the investigators must need large scaled randomized control study including of SOD.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Diclofenac

Criteria

Inclusion Criteria:

Consecutive patients were recruited for the study who presented to the Yonsei University Medical Center with variable symptom or cause for ERCP older than 20 years.

Exclusion Criteria:

Patients were excluded from study participation if:

• they had a contraindication for diclofenac,

• including patients with recently diagnosed peptic ulcer disease or active/recent gastrointestinal hemorrhage within 4 weeks,

• renal failure (Cr > 1.4),

• those who had taken an NSAID during the preceding week (ASA 325 mg daily or less acceptable),

• those who developed acute pancreatitis during the 2 weeks before ERCP,

• those with a history of chronic calcific pancreatitis or allergy to aspirin or NSAID, and

• those who did not agree intramuscular injection. Additionally, if state of patients was intrauterine pregnancy or breast feeding mother, they were excluded. Finally, patients were excluded for study if they had bleeding tendency and contraindication for intramuscular injection.