title: Diagnostic and therapeutic single-operator cholangiopancreatoscopy in biliopancreatic diseases: Prospective multicenter study in Japan.
abstract: OBJECTIVE
  To assess the utility and safety of single-operator cholangiopancreatoscopy (SOCPS) using the SpyGlass system in widespread clinical application for biliary and pancreatic diseases.
  
  
  METHODS
  This study was a prospective case series conducted in 20 referral centers in Japan. There were 148 patients who underwent SOCPS; 124 for biliary diseases and 24 for pancreatic diseases. The attempted interventions were SOCPS examination, SOCPS-directed tissue sampling, and therapy for stone removal, among others. The main outcomes were related to the procedure success rate in terms of visualizing the target lesions, SOCPS-directed adequate tissue sampling, and complete stone removal.
  
  
  RESULTS
  A total of 148 patients were enrolled for the diagnosis of indeterminate biliary and pancreatic lesions or treatment of biliary and pancreatic disease. The overall procedure success rate of visualizing the target lesions was 91.2% (135/148). The overall procedural success rates of visualizing the target lesions of diagnostic SOCPS in the bile duct and pancreatic duct were 95.5% (84/89) and 88.2% (15/17), respectively.
  
  
  METHODS
  the overall adequate tissue for histologic examination was secured in 81.4% of the 86 patients who underwent biopsy under SOCPS (bile duct, 60/75, 80.0%; pancreatic duct, 10/11, 90.9%). The accuracy of histologic diagnosis using SOCPS-directed biopsies in indeterminate bile duct lesions was 70.7% (53/75). In the pancreatic duct, the accuracy of SOCPS visual impression of intraductal papillary mucinous neoplasm was 87.5% (14/16). Stone therapy: complete biliary and pancreatic stone clearance combined with SOCPS-directed stone therapy using electrohydraulic lithotripsy or laser lithotripsy was achieved in 74.2% (23/31) and 42.9% (3/7) of the patients, respectively. Others: SOCPS using the SpyGlass system was used in cannulation of the cystic duct in two patients and for passing across the obstructed self-expandable metallic stent for a malignant biliary stricture in two patients. All procedures were successful in both SOCPS-guided therapies. The incidence of procedure-related adverse events was 5.4% (8/148).
  
  
  CONCLUSIONS
  SOCPS with direct visualization and biopsy for diagnosis and SOCPS-directed therapy for biliary and pancreatic diseases can be safely performed with a high success rate. The clinical trial was registered at UMIN CTR (http://www.umin.ac.jp). The registration identification number is UMIN000015155.
authors: Toshio Kurihara, Takao Itoi, Department of Gastroenterology and Hepatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan.
authors: Toshio
authors: T
authors: Kurihara
authors: Toshio Kurihara, Takao Itoi, Department of Gastroenterology and Hepatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan.
authors: Ichiro
authors: I
authors: Yasuda
authors: Toshio Kurihara, Takao Itoi, Department of Gastroenterology and Hepatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan.
authors: Hiroyuki
authors: H
authors: Isayama
authors: Toshio Kurihara, Takao Itoi, Department of Gastroenterology and Hepatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan.
authors: Toshio
authors: T
authors: Tsuyuguchi
authors: Toshio Kurihara, Takao Itoi, Department of Gastroenterology and Hepatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan.
authors: Taketo
authors: T
authors: Yamaguchi
authors: Toshio Kurihara, Takao Itoi, Department of Gastroenterology and Hepatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan.
authors: Ken
authors: K
authors: Kawabe
authors: Toshio Kurihara, Takao Itoi, Department of Gastroenterology and Hepatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan.
authors: Yoshinobu
authors: Y
authors: Okabe
authors: Toshio Kurihara, Takao Itoi, Department of Gastroenterology and Hepatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan.
authors: Keiji
authors: K
authors: Hanada
authors: Toshio Kurihara, Takao Itoi, Department of Gastroenterology and Hepatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan.
authors: Tsuyoshi
authors: T
authors: Hayashi
authors: Toshio Kurihara, Takao Itoi, Department of Gastroenterology and Hepatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan.
authors: Takao
authors: T
authors: Ohtsuka
authors: Toshio Kurihara, Takao Itoi, Department of Gastroenterology and Hepatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan.
authors: Syuhei
authors: S
authors: Oana
authors: Toshio Kurihara, Takao Itoi, Department of Gastroenterology and Hepatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan.
authors: Hiroshi
authors: H
authors: Kawakami
authors: Toshio Kurihara, Takao Itoi, Department of Gastroenterology and Hepatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan.
authors: Yoshinori
authors: Y
authors: Igarashi
authors: Toshio Kurihara, Takao Itoi, Department of Gastroenterology and Hepatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan.
authors: Kazuya
authors: K
authors: Matsumoto
authors: Toshio Kurihara, Takao Itoi, Department of Gastroenterology and Hepatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan.
authors: Kiichi
authors: K
authors: Tamada
authors: Toshio Kurihara, Takao Itoi, Department of Gastroenterology and Hepatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan.
authors: Shomei
authors: S
authors: Ryozawa
authors: Toshio Kurihara, Takao Itoi, Department of Gastroenterology and Hepatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan.
authors: Hiroki
authors: H
authors: Kawashima
authors: Toshio Kurihara, Takao Itoi, Department of Gastroenterology and Hepatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan.
authors: Yutaka
authors: Y
authors: Okamoto
authors: Toshio Kurihara, Takao Itoi, Department of Gastroenterology and Hepatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan.
authors: Iruru
authors: I
authors: Maetani
authors: Toshio Kurihara, Takao Itoi, Department of Gastroenterology and Hepatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan.
authors: Hiroyuki
authors: H
authors: Inoue
authors: Toshio Kurihara, Takao Itoi, Department of Gastroenterology and Hepatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan.
authors: Takao
authors: T
authors: Itoi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001660:Biliary Tract Diseases / Q000000981:diagnostic imaging* / Q000601:surgery*; D001706:Biopsy; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects / Q000295:instrumentation; D019723:Endoscopes; D016145:Endoscopy, Digestive System / Q000009:adverse effects / Q000295:instrumentation; D004867:Equipment Design; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D010182:Pancreatic Diseases / Q000000981:diagnostic imaging* / Q000601:surgery*; D011183:Postoperative Complications / Q000209:etiology; D011237:Predictive Value of Tests; D011446:Prospective Studies; D015607:Stents; D016896:Treatment Outcome
keywords: Cholangioscopy; Endoscopic retrograde cholangiopancreatography; Pancreatoscopy; Single-operator; SpyGlass