title: Results of the Tokyo trial of prevention of post-ERCP pancreatitis with risperidone-2: a multicenter, randomized, placebo-controlled, double-blind clinical trial.
abstract: BACKGROUND
  Our previous study suggested that a combination of ulinastatin and risperidone reduced post-ERCP pancreatitis (PEP) compared with ulinastatin alone.
  
  
  OBJECTIVE
  The aim of this study was to evaluate the efficacy of risperidone alone for prevention of PEP.
  
  
  METHODS
  A multicenter, randomized, placebo-controlled, double-blind clinical trial.
  
  
  METHODS
  Two academic hospitals and 5 referral hospitals in Tokyo and Saitama, Japan.
  
  
  METHODS
  Patients undergoing therapeutic or interventional-diagnostic ERCP.
  
  
  METHODS
  The patients were randomized to receive 2 mg of oral risperidone or oral placebo at 0.5 to 2 hours before ERCP.
  
  
  METHODS
  The primary endpoint was the incidence of PEP. Secondary endpoints were the incidence of hyperenzymemia and enzyme levels (amylase, pancreatic amylase, lipase). Risk factors for PEP were evaluated.
  
  
  RESULTS
  We initially enrolled 500 patients in the study (250 in the risperidone group and 250 in the placebo group), but 17 (11 in the risperidone and 6 in the placebo group) were excluded after randomization. PEP developed in 24 patients (10.0%) in the risperidone group and 21 patients (8.6%) in the placebo group (P = .587). Serum amylase levels at 3 hours after ERCP were lower in the risperidone group (P = .007 in a single test of hypothesis, significance removed by Bonferroni correction for multiple testing). In multivariate analysis, a small papilla of Vater, total procedure time ≥40 minutes, and stenosis of the intrahepatic duct were significantly associated with PEP.
  
  
  CONCLUSIONS
  Multiplicity of study centers and a relatively wide time range of drug administration time.
  
  
  CONCLUSIONS
  Risperidone did not show a benefit in prevention of PEP in this trial. (
  
  
  BACKGROUND
  NCT000004592.).
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors.forename: Rie
authors.initials: R
authors.lastname: Uchino
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Isayama
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; Department of Gastroenterology, Japanese Red Cross Medical Center, Tokyo, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Tsujino
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors.forename: Naoki
authors.initials: N
authors.lastname: Sasahira
authors.affiliation: Department of Gastroenterology, Japanese Red Cross Medical Center, Tokyo, Japan.
authors.forename: Yukiko
authors.initials: Y
authors.lastname: Ito
authors.affiliation: Department of Gastroenterology, Tokyo Metropolitan Police Hospital, Tokyo, Japan.
authors.forename: Saburo
authors.initials: S
authors.lastname: Matsubara
authors.affiliation: Department of Gastroenterology, Kanto Central Hospital, Tokyo, Japan.
authors.forename: Naminatsu
authors.initials: N
authors.lastname: Takahara
authors.affiliation: Department of Gastroenterology, Mitsui Memorial Hospital, Tokyo, Japan.
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Arizumi
authors.affiliation: Department of Gastroenterology, Mitsui Memorial Hospital, Tokyo, Japan.
authors.forename: Nobuo
authors.initials: N
authors.lastname: Toda
authors.affiliation: Department of Gastroenterology, Saitama Medical University International Medical Center, Saitama, Japan.
authors.forename: Dai
authors.initials: D
authors.lastname: Mohri
authors.affiliation: Department of Gastroenterology, Saitama Medical University International Medical Center, Saitama, Japan.
authors.forename: Osamu
authors.initials: O
authors.lastname: Togawa
authors.affiliation: Department of Gastroenterology, JR Tokyo General Hospital, Tokyo, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Yagioka
authors.affiliation: Department of Pharmacy, The University of Tokyo Hospital, Faculty of Medicine, The University of Tokyo, Tokyo, Japan.
authors.forename: Yoshitsugu
authors.initials: Y
authors.lastname: Yanagihara
authors.affiliation: Department of Pharmacy, The University of Tokyo Hospital, Faculty of Medicine, The University of Tokyo, Tokyo, Japan.
authors.forename: Katsuyoshi
authors.initials: K
authors.lastname: Nakajima
authors.affiliation: Department of Gastroenterology, Japanese Red Cross Medical Center, Tokyo, Japan.
authors.forename: Dai
authors.initials: D
authors.lastname: Akiyama
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Hamada
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Miyabayashi
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors.forename: Suguru
authors.initials: S
authors.lastname: Mizuno
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors.forename: Kazumichi
authors.initials: K
authors.lastname: Kawakubo
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Kogure
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Sasaki
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors.forename: Natsuyo
authors.initials: N
authors.lastname: Yamamoto
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors.forename: Yousuke
authors.initials: Y
authors.lastname: Nakai
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Hirano
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors.forename: Minoru
authors.initials: M
authors.lastname: Tada
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Koike
mesh_terms: D000328:Adult; D000368:Aged; D014670:Ampulla of Vater / Q000033:anatomy & histology*; D000681:Amylases / Q000097:blood; D001653:Bile Ducts, Intrahepatic / Q000473:pathology*; D002097:C-Reactive Protein / Q000378:metabolism; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects*; D003251:Constriction, Pathologic / Q000150:complications; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007958:Leukocyte Count; D008049:Lipase / Q000097:blood; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D009929:Organ Size; D010195:Pancreatitis / Q000209:etiology / Q000517:prevention & control*; D018967:Risperidone / Q000627:therapeutic use*; D012702:Serotonin Antagonists / Q000627:therapeutic use*; D014041:Tokyo; D055815:Young Adult
chemical_list: D012702:Serotonin Antagonists; D002097:C-Reactive Protein; D008049:Lipase; D000681:Amylases; D018967:Risperidone
keywords: 5-HT; 5-hydroxytryptamine; PEP; p-amylase; pancreatic amylase; post-ERCP pancreatitis