November 12, 2014
Author Address: School of Medicine, University of Tasmania, Hobart, Tasmania, Australia.
Reference Type: Journal Article
Record Number: 5048Author: Uchino, R., Isayama, H., Tsujino, T., Sasahira, N., Ito, Y., Matsubara, S., Takahara, N., Arizumi, T., Toda, N., Mohri, D., Togawa, O., Yagioka, H., Yanagihara, Y., Nakajima, K., Akiyama, D., Hamada, T., Miyabayashi, K., Mizuno, S., Kawakubo, K., Kogure, H., Sasaki, T., Yamamoto, N., Nakai, Y., Hirano, K., Tada, M. and Koike, K.
Title: Results of the Tokyo trial of prevention of post-ERCP pancreatitis with risperidone-2: a multicenter, randomized, placebo-controlled, double-blind clinical trial
Journal: Gastrointest Endosc
Short Title: Results of the Tokyo trial of prevention of post-ERCP pancreatitis with risperidone-2: a multicenter, randomized, placebo-controlled, double-blind clinical trial
Alternate Journal: Gastrointestinal endoscopy
ISSN: 1097-6779 (Electronic)
Accession Number: 23910063
Ampulla of Vater/*anatomy & histology
Bile Ducts, Intrahepatic/*pathology
Cholangiopancreatography, Endoscopic Retrograde/*adverse effects
Pancreatitis/etiology/*prevention & control
Serotonin Antagonists/*therapeutic use
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. DESIGN: A multicenter, randomized, placebo-controlled, double-blind clinical trial. SETTING: Two academic hospitals and 5 referral hospitals in Tokyo and Saitama, Japan. PATIENTS: Patients undergoing therapeutic or interventional-diagnostic ERCP. INTERVENTION: The patients were randomized to receive 2 mg of oral risperidone or oral placebo at 0.5 to 2 hours before ERCP. MAIN OUTCOME MEASUREMENTS: 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. LIMITATIONS: Multiplicity of study centers and a relatively wide time range of drug administration time. CONCLUSION: Risperidone did not show a benefit in prevention of PEP in this trial. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT000004592.).