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A Multicenter, Prospective, Randomized Controlled Trial Evaluating The Efficacy Of Rectal Diclofenac And Sublingual Nitroglycerin As A Combined Prophylactic Treatment For Post-ERCP Pancreatitis.

T. Tomoda, H. Kato, Sho Mizukawa, Shinichiro Muro, Y. Akimoto, D. Uchida, K. Matsumoto, N. Yamamoto, S. Horiguchi, K. Tsutsumi, H. Okada
Published 2016 · Medicine

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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 nitroglycerin 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 nitroglycerin 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 nitroglycerin can prevent PEP.
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