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Acta Med Okayama. 2017 Aug;71(4):357-362. doi: 10.18926/AMO/55314.

A Multicenter, Prospective, Randomized Controlled Trial Evaluating the Efficacy of Rectal Diclofenac and Sublingual Nitrate as a Combined Prophylactic Treatment for Post-ERCP Pancreatitis.

Acta medica Okayama

Takeshi Tomoda, Hironari Kato, Sho Mizukawa, Shinichiro Muro, Yutaka Akimoto, Daisuke Uchida, Kazuyuki Matsumoto, Naoki Yamamoto, Shigeru Horiguchi, Koichiro Tsutsumi, Hiroyuki Okada


  1. Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama 700-8558, Japan.

PMID: 28824193 DOI: 10.18926/AMO/55314


Acute pancreatitis is the major complication of endoscopic retrograde cholangiopancreatography(ERCP). A preliminary research suggested that the administration of nonsteroidal anti-inflammatory drugs (NSAIDs) with nitrate might reduce the incidence of post-ERCP pancreatitis (PEP) more effectively than NSAIDs alone. We conduct a two-arm, multicenter, prospective, randomized, superiority trial to evaluate the additional effect of nitrate for prevention of PEP. A total of 900 patients randomly receive 50 mg diclofenac suppository either alone or with 5 mg isosorbide dinitrate sublingual tablet. The primary endpoint is the occurrence of PEP. This study will clarify whether NSAIDs plus nitrate can prevent PEP.

Keywords: NSAIDs; nitrate; post-ERCP pancreatitis

Conflict of interest statement

No potential conflict of interest relevant to this article was reported.

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