Intramuscular Diclofenac in the Prevention of Post-ERCP Pancreatitis

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.

Timeline

Start

2012-08-29

Primary completion

2013-08-28

Completion

2013-08-28

Outcome

Missed primary endpoint

paper PEP developed in 20/170 patients (11.8 %) in the placebo group and in 22/173 patients (12.7 %) in the diclofenac group (P = 0.87). PMID 25409167 ↗

paper Prophylactic intramuscular diclofenac had no beneficial preventive effect on PEP. PMID 25409167 ↗

Publications

• Park SW, Chung MJ, Oh TG, Park JY, Bang S, Park SW, Song SY. Intramuscular diclofenac for the prevention of post-ERCP pancreatitis: a randomized trial. Endoscopy. 2015 Jan;47(1):33-9. doi: 10.1055/s-0034-1390743. Epub 2014 Nov 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Diclofenac	Other / unclassified	90 mg	Intramuscular

Indications