title: Single-operator cholangioscopy in patients requiring evaluation of bile duct disease or therapy of biliary stones (with videos).
abstract: BACKGROUND
  The feasibility of single-operator cholangioscopy (SOC) for biliary diagnostic and therapeutic procedures was previously reported.
  
  
  OBJECTIVE
  To confirm the utility of SOC in more widespread clinical use.
  
  
  METHODS
  Prospective clinical cohort study.
  
  
  METHODS
  Fifteen endoscopy referral centers in the United States and Europe.
  
  
  METHODS
  Two hundred ninety-seven patients requiring evaluation of bile duct disease or biliary stone therapy.
  
  
  METHODS
  SOC examination and, as indicated, SOC-directed stone therapy or forceps biopsy.
  
  
  METHODS
  Procedural success defined as ability to (1) visualize target lesions and, if indicated, collect biopsy specimens adequate for histological evaluation or (2) visualize biliary stones and initiate fragmentation and removal.
  
  
  RESULTS
  The overall procedure success rate was 89% (95% CI, 84%-92%). Adequate tissue for histological examination was secured in 88% of 140 patients who underwent biopsy. Overall sensitivity in diagnosing malignancy was 78% for SOC visual impression and 49% for SOC-directed biopsy. Sensitivity was higher (84% and 66%, respectively) for intrinsic bile duct malignancies. Diagnostic SOC procedures altered clinical management in 64% of patients. Procedure success was achieved in 92% of 66 patients with stones and complete stone clearance during the study SOC session in 71%. The incidence of serious procedure-related adverse events was 7.5% for diagnostic SOC and 6.1% for SOC-directed stone therapy.
  
  
  CONCLUSIONS
  The study was observational in design with no control group.
  
  
  CONCLUSIONS
  Evaluation of bile duct disease and biliary stone therapy can be safely performed with a high success rate by using the SOC system.
authors.affiliation: University of Colorado Health Sciences Center, Denver, CO, USA.
authors.forename: Yang K
authors.initials: YK
authors.lastname: Chen
authors.forename: Mansour A
authors.initials: MA
authors.lastname: Parsi
authors.forename: Kenneth F
authors.initials: KF
authors.lastname: Binmoeller
authors.forename: Robert H
authors.initials: RH
authors.lastname: Hawes
authors.forename: Douglas K
authors.initials: DK
authors.lastname: Pleskow
authors.forename: Adam
authors.initials: A
authors.lastname: Slivka
authors.forename: Oleh
authors.initials: O
authors.lastname: Haluszka
authors.forename: Bret T
authors.initials: BT
authors.lastname: Petersen
authors.forename: Stuart
authors.initials: S
authors.lastname: Sherman
authors.forename: Jacques
authors.initials: J
authors.lastname: Devière
authors.forename: Søren
authors.initials: S
authors.lastname: Meisner
authors.forename: Peter D
authors.initials: PD
authors.lastname: Stevens
authors.forename: Guido
authors.initials: G
authors.lastname: Costamagna
authors.forename: Thierry
authors.initials: T
authors.lastname: Ponchon
authors.forename: Joyce A
authors.initials: JA
authors.lastname: Peetermans
authors.forename: Horst
authors.initials: H
authors.lastname: Neuhaus
mesh_terms: D001649:Bile Duct Diseases / Q000175:diagnosis* / Q000628:therapy; D001650:Bile Duct Neoplasms / Q000175:diagnosis; D001706:Biopsy; D002404:Catheterization; D002760:Cholangiopancreatography, Endoscopic Retrograde; D002769:Cholelithiasis / Q000175:diagnosis* / Q000628:therapy; D016145:Endoscopy, Digestive System / Q000009:adverse effects / Q000295:instrumentation; D005260:Female; D006801:Humans; D008096:Lithotripsy; D017602:Lithotripsy, Laser; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D014743:Videotape Recording