title: Diagnostic performance of a new endoscopic scraper for malignant biliary strictures: a multicenter prospective study.
abstract: OBJECTIVE
  The efficacy of ERCP for histologic diagnosis of malignant biliary strictures is disappointingly low. The aim of this study was to investigate the diagnostic performance of a newly developed endoscopic device with scraping loops in combination with conventional biopsy forceps.
  
  
  METHODS
  We performed a multicenter single-arm prospective study. Between February 2013 and December 2014, 123 patients with suspected malignant biliary strictures were enrolled in the study. The new device and conventional biopsy forceps were applied for histologic diagnosis by ERCP. The primary outcome was to evaluate cancer detectability by biopsy forceps, the new device, and their combined use.
  
  
  RESULTS
  Of the 123 patients, 119 were diagnosed with a malignant stricture. Sufficient samples were collected in 83.7% (103/123), 93.5% (115/123), and 95.9% (118/123) of patients using biopsy forceps, the new device, and their combination, respectively. Cancer detectability of forceps biopsy, the new device, and their combination were 51.3% (61/119), 64.7% (77/119), and 74.8% (89/119), respectively. The new device had a significantly higher sample yield and cancer detectability than biopsy forceps (P < .01 and P = .018, respectively, McNemar test). Complementary use of the new device with biopsy forceps demonstrated a significantly additive effect in both sample yield and cancer detection (P < .01 each, McNemar test). The new device detected 48.3% (28/58) of cancers that were not diagnosed as malignant by biopsy forceps.
  
  
  CONCLUSIONS
  The new endoscopic scraper demonstrated a large sample yield and high cancer detectability. It could be a first-line tissue-sampling device for biliary strictures. (University Hospital Medical Information Network Clinical Trial Registry [UMIN-CTR] (http://www.umin.ac.jp/ctr/index.htm) registration number: UMIN000009895.).
authors: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Kyoto University, Kyoto, Japan; Division of Gastroenterology and Hepatology, Digestive Disease Center, The Tazuke Kofukai Medical Research Institute Kitano Hospital, Osaka, Japan.
authors: Yojiro
authors: Y
authors: Sakuma
authors: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
authors: Yuzo
authors: Y
authors: Kodama
authors: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Kyoto University, Kyoto, Japan; Department of Gastroenterology and Hepatology, Otsu Red Cross Hospital, Otsu, Japan.
authors: Yuko
authors: Y
authors: Sogabe
authors: Department of Gastroenterology and Hepatology, Kyoto Katsura Hospital, Kyoto, Japan.
authors: Yoshitaka
authors: Y
authors: Nakai
authors: Department of Gastroenterology and Hepatology, Japanese Red Cross Society, Wakayama Medical Center, Wakayama, Japan.
authors: Yukitaka
authors: Y
authors: Yamashita
authors: Department of Gastroenterology and Hepatology, Kobe City Hospital Organization, Kobe City Medical Center West Hospital, Kobe, Japan.
authors: Sakae
authors: S
authors: Mikami
authors: Department of Gastroenterology and Hepatology, Kishiwada City Hospital, Kishiwada, Japan.
authors: Kozo
authors: K
authors: Kajimura
authors: Department of Gastroenterology and Hepatology, Kansai Denryoku Hospital, Osaka, Japan.
authors: Kazuki
authors: K
authors: Ikeda
authors: Department of Gastroenterology and Hepatology, Takamatsu Red Cross Hospital, Takamatsu, Japan.
authors: Hiroyuki
authors: H
authors: Tamaki
authors: Department of Gastroenterology and Hepatology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.
authors: Satoru
authors: S
authors: Iwamoto
authors: Department of Gastroenterology and Hepatology, Osaka Red Cross Hospital, Osaka, Japan.
authors: Fumihiro
authors: F
authors: Matsuda
authors: Division of Gastroenterology and Hepatology, Digestive Disease Center, The Tazuke Kofukai Medical Research Institute Kitano Hospital, Osaka, Japan; Kyoto University Health Service, Kyoto, Japan; Department of Gastroenterology, Yodogawa Christian Hospital, Osaka, Japan.
authors: Koichi
authors: K
authors: Fujita
authors: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
authors: Norimitsu
authors: N
authors: Uza
authors: Kyoto University Health Service, Kyoto, Japan.
authors: Takashi
authors: T
authors: Kawamura
authors: Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
authors: Shinji
authors: S
authors: Uemoto
authors: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
authors: Hiroshi
authors: H
authors: Seno
authors: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
authors: Tsutomu
authors: T
authors: Chiba
authors: Division of Gastroenterology and Hepatology, Digestive Disease Center, The Tazuke Kofukai Medical Research Institute Kitano Hospital, Osaka, Japan.
authors: Shujiro
authors: S
authors: Yazumi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001649:Bile Duct Diseases / Q000175:diagnosis* / Q000209:etiology; D001650:Bile Duct Neoplasms / Q000150:complications / Q000175:diagnosis / Q000473:pathology*; D001652:Bile Ducts / Q000473:pathology*; D001706:Biopsy / Q000295:instrumentation*; D018281:Cholangiocarcinoma / Q000150:complications / Q000175:diagnosis / Q000473:pathology*; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000295:instrumentation*; D003251:Constriction, Pathologic; D005260:Female; D005706:Gallbladder Neoplasms / Q000150:complications / Q000175:diagnosis / Q000473:pathology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000150:complications / Q000175:diagnosis / Q000473:pathology*; D011446:Prospective Studies