title: A Multicenter, Prospective, Randomized Controlled Trial Evaluating the Efficacy of Rectal Diclofenac and Sublingual Nitroglycerin as a Combined Prophylactic Treatment for Post-ERCP Pancreatitis.
abstract: 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.
authors: Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama 700-8558, Japan.tomotake79@yahoo.co.jp.
authors: Takeshi
authors: T
authors: Tomoda
authors: Hironari
authors: H
authors: Kato
authors: Sho
authors: S
authors: Mizukawa
authors: Shinichiro
authors: S
authors: Muro
authors: Yutaka
authors: Y
authors: Akimoto
authors: Daisuke
authors: D
authors: Uchida
authors: Kazuyuki
authors: K
authors: Matsumoto
authors: Naoki
authors: N
authors: Yamamoto
authors: Shigeru
authors: S
authors: Horiguchi
authors: Koichiro
authors: K
authors: Tsutsumi
authors: Hiroyuki
authors: H
authors: Okada
mesh_terms: D000285:Administration, Rectal; D000286:Administration, Sublingual; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects*; D002985:Clinical Protocols; D004008:Diclofenac / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D005996:Nitroglycerin / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D010195:Pancreatitis / Q000209:etiology / Q000517:prevention & control*; D011183:Postoperative Complications / Q000517:prevention & control*
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D004008:Diclofenac; D005996:Nitroglycerin