title: Clinical evaluation of a prototype multi-bending peroral direct cholangioscope.
abstract: BACKGROUND
  Although peroral direct cholangioscopy (PDCS) is emerging as an alternative to traditional mother-daughter cholangioscopy, it is associated with high failure rates. The aim of the present study was to evaluate the ability to insert and carry out interventions using a prototype multi-bending PDCS.
  
  
  METHODS
  Prospective, observational clinical feasibility study was done in 41 patients with a variety of biliary diseases. A multi-bending PDCS prototype was inserted using a free-hand technique, a guidewire alone, or with a 5-Fr diameter anchoring balloon. Diagnostic and therapeutic procedures were carried out.
  
  
  RESULTS
  The free-hand direct insertion technique failed in all attempted cases (n = 7). Of the remaining 34 cases, successful rate of PDCS insertion into the distal bile duct was achieved by passing the PDCS over a guidewire alone (n = 6) and/or with a guidewire plus anchoring balloon (n = 28) for an overall successrate of 88.2% (30/34). In 13 (92.9%) patients without an underlying biliary stricture, PDCS insertion proximal to the bifurcation was possible. In 25 cases, biliary interventions were attempted including biopsy (n = 13), stone removal (n = 6), stent removal (n = 1), and intraductal electrohydraulic lithotripsy (n = 2) and were successful in 22 (88%). Other than two patients with procedure-related cholangitis with a mild grade of severity, no complications were observed.
  
  
  CONCLUSIONS
  Using a novel multi-bending prototype peroral direct cholangioscope, cholangioscopy had a high diagnostic and therapeutic success rate only when passed over a guidewire and anchoring balloon but not with the free-hand insertion technique. Comparative studies of direct cholangioscopy are warranted.
authors.affiliation: Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan.
authors.forename: Takao
authors.initials: T
authors.lastname: Itoi
authors.forename: D
authors.initials: D
authors.lastname: Nageshwar Reddy
authors.forename: Atsushi
authors.initials: A
authors.lastname: Sofuni
authors.forename: Mohan
authors.initials: M
authors.lastname: Ramchandani
authors.forename: Fumihide
authors.initials: F
authors.lastname: Itokawa
authors.forename: Rajesh
authors.initials: R
authors.lastname: Gupta
authors.forename: Toshio
authors.initials: T
authors.lastname: Kurihara
authors.forename: Takayoshi
authors.initials: T
authors.lastname: Tsuchiya
authors.forename: Kentaro
authors.initials: K
authors.lastname: Ishii
authors.forename: Nobuhito
authors.initials: N
authors.lastname: Ikeuchi
authors.forename: Fuminori
authors.initials: F
authors.lastname: Moriyasu
authors.forename: Jong Ho
authors.initials: JH
authors.lastname: Moon
mesh_terms: D001649:Bile Duct Diseases / Q000601:surgery*; D002769:Cholelithiasis / Q000601:surgery*; D019723:Endoscopes; D016145:Endoscopy, Digestive System / Q000295:instrumentation* / Q000379:methods; D004867:Equipment Design; D006801:Humans; D008096:Lithotripsy
keywords: endoscopic retrograde cholangiopancreatography (ERCP); peroral direct cholangioscopy
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