title: Diagnostic accuracy of conventional and cholangioscopy-guided sampling of indeterminate biliary lesions at the time of ERCP: a prospective, long-term follow-up study.
abstract: BACKGROUND
  The diagnostic accuracy of cholangioscopy-guided sampling has not been rigorously evaluated.
  
  
  OBJECTIVE
  To prospectively evaluate the accuracy of cholangioscopy-guided mini-forceps sampling and compare it with standard cytology brushings and forceps biopsies for the tissue diagnosis of indeterminate biliary lesions.
  
  
  METHODS
  Prospective, long-term follow-up, paired design cohort study.
  
  
  METHODS
  Tertiary center.
  
  
  METHODS
  Patients undergoing cholangioscopy for the evaluation of indeterminate biliary lesions.
  
  
  METHODS
  Each patient underwent triple sampling with cholangioscopy-guided mini-forceps, cytology brushing, and standard forceps.
  
  
  METHODS
  Diagnostic accuracy of each sampling method compared with the patient final status (cancer vs no cancer).
  
  
  RESULTS
  A total of 26 patients (17 cancer positive/9 cancer negative) were enrolled. The mean follow-up in the patients with no cancer was 21.78 (SD ±6.78) months. The procedure was technically successful in all cases (100%). Sample quality was adequate in 25 of 26 (96.2%) of the cytology brushings, in 26 of 26 (100%) of the standard forceps biopsies, and in 25 of 26 (96.2%) of the mini-forceps biopsies. The sensitivity, accuracy, and negative predictive values were 5.9%, 38.5%, and 36% for standard cytology brushings; 29.4%, 53.8%, and 42.8% for standard forceps biopsies; and 76.5%, 84.6%, and 69.2% for mini-forceps biopsies, respectively. When comparing the 3 methods of sampling, mini-forceps biopsy provided significantly better sensitivity and overall accuracy compared with standard cytology brushing (P < .0001) and standard forceps biopsy (P = .0215).
  
  
  CONCLUSIONS
  Potential for selection bias.
  
  
  CONCLUSIONS
  Cholangioscopy-guided biopsies of indeterminate biliary lesions have significantly higher accuracy compared with ERCP-guided cytology brushings and standard forceps biopsies, but negative findings on mini-forceps biopsy cannot rule out malignancy with a high degree of certainty. (
  
  
  BACKGROUND
  NCT01227382.).
authors.affiliation: Department of Medicine, University of Florida College of Medicine, Gainesville, Florida 32610, USA.
authors.forename: Peter V
authors.initials: PV
authors.lastname: Draganov
authors.forename: Shailendra
authors.initials: S
authors.lastname: Chauhan
authors.forename: Mihir S
authors.initials: MS
authors.lastname: Wagh
authors.forename: Anand R
authors.initials: AR
authors.lastname: Gupte
authors.forename: Tong
authors.initials: T
authors.lastname: Lin
authors.forename: Wei
authors.initials: W
authors.lastname: Hou
authors.forename: Chris E
authors.initials: CE
authors.lastname: Forsmark
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001650:Bile Duct Neoplasms / Q000473:pathology*; D001653:Bile Ducts, Intrahepatic / Q000473:pathology*; D001706:Biopsy / Q000295:instrumentation / Q000379:methods; D018281:Cholangiocarcinoma / Q000473:pathology*; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000295:instrumentation; D015529:Choledochal Cyst / Q000473:pathology; D003251:Constriction, Pathologic / Q000175:diagnosis; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000473:pathology*; D011446:Prospective Studies; D012680:Sensitivity and Specificity