Endoscopy 2015; 47(01): 33-39
DOI: 10.1055/s-0034-1390743
Original article
© Georg Thieme Verlag KG Stuttgart · New York

Intramuscular diclofenac for the prevention of post-ERCP pancreatitis: a randomized trial

Se Woo Park
1  Department of Internal Medicine, Institute of Gastroenterology, Hallym University College of Medicine, Seoul, Korea
,
Moon Jae Chung
2  Department of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea
,
Tak Geun Oh
2  Department of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea
,
Jeong Youp Park
2  Department of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea
,
Seungmin Bang
2  Department of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea
,
Seung Woo Park
2  Department of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea
,
Si Young Song
2  Department of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea
› Author Affiliations
Further Information

Publication History

submitted 28 February 2014

accepted after revision 06 August 2014

Publication Date:
19 November 2014 (online)

Background and study aims: Rectal nonsteroidal anti-inflammatory drugs have been shown to reduce the incidence of postendoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). The aim of this study was to determine whether intramuscular diclofenac reduces the risk of PEP.

Patients and methods: Patients who underwent ERCP were randomized to receive either 90 mg of diclofenac or placebo by intramuscular injection immediately after the procedure. PEP was defined as elevated serum amylase levels (at least three times the upper limit of normal 24 hours after the procedure) associated with new or worsened upper abdominal, epigastric, or back pain.

Results: In total, 380 patients were randomized, and 343 were eligible for analysis. The two groups were similar regarding clinical and demographic factors, as well as patient- and procedure-related risk factors for PEP. 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). Multivariate regression analysis failed to illustrate that intramuscular diclofenac prevented PEP (odds ratio 0.79; 95 % confidence interval 0.39 – 1.25; P = 0.51).

Conclusion: Prophylactic intramuscular diclofenac had no beneficial preventive effect on PEP.

Clinicaltrials.gov NCT01717599.