title: No Benefit of Oral Diclofenac on Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis.
abstract: Pancreatitis following endoscopic retrograde cholangiopancreatography (ERCP) is a serious complication. Rectal diclofenac (100 mg) has been shown to reduce the incidence of pancreatitis; however, this dosage form is unavailable in several countries.
  
  
  
  We aimed to investigate the preventive effect of oral diclofenac on pancreatitis after ERCP in a multicenter, randomized, prospective, placebo-controlled, double-blind trial.
  
  
  
  Patients undergoing a first ERCP in seven high-volume centers between July 2012 and August 2014 were considered eligible. Participants were administered oral diclofenac (50 mg) or placebo before and after ERCP. The primary endpoint was the incidence of pancreatitis. A subgroup analysis was performed for patients at high or low risk of pancreatitis. Secondary endpoints were pancreatic enzyme levels (amylase and lipase).
  
  
  
  We initially enrolled 430 patients (216 in the diclofenac and 214 in the placebo group), and 23 were excluded after randomization. The overall incidence of pancreatitis was 9.8 % (20/205) and 9.4 % (19/202) in the diclofenac and placebo groups, respectively (p = 0.90). The incidence of pancreatitis was 20.3 % (13/64) and 21.3 % (13/61) in patients at high risk of pancreatitis (p = 0.78) and 5.0 % (7/141) and 4.3 % (6/141) in patients at low risk of pancreatitis in the diclofenac and placebo groups (p = 0.94), respectively. There were no significant differences in serum amylase and lipase levels between the two groups before and 24 h after ERCP.
  
  
  
  Oral administration of diclofenac before and after ERCP showed no benefit in the prevention of pancreatitis.
  
  
  
  UMIN000008109.
authors.affiliation: Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan. ishihiro481019@gmail.com.
authors.forename: Hirotoshi
authors.initials: H
authors.lastname: Ishiwatari
authors.affiliation: Department of Gastroenterology, Japanese Red Cross Kumamoto Hospital, 1-1-2, Nagamineminami, Higashiku, Kumamoto, 861-8520, Japan.
authors.forename: Takahiro
authors.initials: T
authors.lastname: Urata
authors.affiliation: Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, 3-8-3, Mizonokuchi, Takatsuku, Kawasaki, Kanagawa, 213-8507, Japan.
authors.forename: Ichiro
authors.initials: I
authors.lastname: Yasuda
authors.affiliation: Department of Gastroenterology, Suzuka General Hospital, 53-1275, Uyamanohana, Yasuzukacho, Suzuka, Mie, 513-8630, Japan.
authors.forename: Shimpei
authors.initials: S
authors.lastname: Matsusaki
authors.affiliation: Department of Gastroenterology, Japanese Red Cross Date Hospital, 81, Suenagacho, Date, Hokkaido, 052-8511, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Hisai
authors.affiliation: Department of Gastroenterology and Hepatology, Center for Digestive Disease, University of Miyazaki, 5200 Kihara, Kiyotake-cho, Miyazaki City, Miyazaki, 889-1692, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kawakami
authors.affiliation: Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan.
authors.forename: Michihiro
authors.initials: M
authors.lastname: Ono
authors.affiliation: First Department of Internal Medicine, Gifu University Hospital, 1-1, Yanagito, Gifu, Gifu, 501-1194, Japan.
authors.forename: Takuji
authors.initials: T
authors.lastname: Iwashita
authors.affiliation: Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, 3-8-3, Mizonokuchi, Takatsuku, Kawasaki, Kanagawa, 213-8507, Japan.
authors.forename: Shinpei
authors.initials: S
authors.lastname: Doi
authors.affiliation: Department of Gastroenterology and Hepatology, Hokkaido University Hospital, West 5, North 14, Kitaku, Sapporo, Hokkaido, 060-8648, Japan.
authors.forename: Kazumichi
authors.initials: K
authors.lastname: Kawakubo
authors.affiliation: Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan.
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Hayashi
authors.affiliation: Department of Public Health, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan.
authors.forename: Tomoko
authors.initials: T
authors.lastname: Sonoda
authors.affiliation: Department of Gastroenterology and Hepatology, Hokkaido University Hospital, West 5, North 14, Kitaku, Sapporo, Hokkaido, 060-8648, Japan.
authors.forename: Naoya
authors.initials: N
authors.lastname: Sakamoto
authors.affiliation: Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan.
authors.forename: Junji
authors.initials: J
authors.lastname: Kato
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000681:Amylases / Q000097:blood; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D001327:Autoimmune Diseases / Q000175:diagnosis / Q000276:immunology; D001650:Bile Duct Neoplasms / Q000175:diagnosis; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects*; D002761:Cholangitis / Q000175:diagnosis / Q000276:immunology; D002769:Cholelithiasis / Q000175:diagnosis / Q000601:surgery; D004008:Diclofenac / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006785:Hospitals, University; D006801:Humans; D007074:Immunoglobulin G; D008049:Lipase / Q000097:blood; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D010190:Pancreatic Neoplasms / Q000175:diagnosis; D010195:Pancreatitis / Q000097:blood / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D011183:Postoperative Complications / Q000097:blood / Q000209:etiology / Q000517:prevention & control*
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D007074:Immunoglobulin G; D004008:Diclofenac; D008049:Lipase; D000681:Amylases
keywords: Diclofenac; Endoscopic retrograde cholangiopancreatography; Pancreaticobiliary disease; Pancreatitis