title: Prospective randomized comparison of short-access mother-baby cholangioscopy versus direct cholangioscopy with ultraslim gastroscopes.
abstract: BACKGROUND
  Mother-baby technologies, the criterion standard for cholangioscopy, have several limitations. A novel, short-access, mother-baby (SAMBA) system may improve this technique. Direct cholangioscopy (DC) was recently developed as an alternative to mother-baby cholangioscopy.
  
  
  OBJECTIVE
  Comparison of success rates with SAMBA and DC.
  
  
  METHODS
  Single-center, randomized, controlled trial.
  
  
  METHODS
  Academic tertiary-care referral center.
  
  
  METHODS
  Sixty patients with suspected cholangiopathies randomized to either SAMBA (n = 30) or DC (n = 30).
  
  
  METHODS
  Cholangioscopy under deep sedation.
  
  
  METHODS
  Technical success rate of diagnostic or therapeutic procedure.
  
  
  RESULTS
  A total of 24 and 21 diagnostic procedures were performed in the SAMBA and DC groups, respectively. There were no significant differences in the overall technical success rates between SAMBA (90.0%) and DC (86.7%) (P = 1.0). There was better correlation between the endoscopic prediction and histologic findings in DC (P = .013). Procedure times were shorter in DC (P < .03). In patients without significant stenoses, SAMBA allowed intrahepatic bile duct exploration in all cases, compared with 10.5% of cases in DC (P < .01). No differences regarding adverse event rates between the groups occurred (10.0% both groups).
  
  
  CONCLUSIONS
  Small sample size. Heterogeneous indications for cholangioscopy. DC requires advanced skills of the endoscopist. The study is not replicable.
  
  
  CONCLUSIONS
  SAMBA and DC offer high technical success rates for diagnostic and therapeutic interventions. The advantages of DC consist of superior imaging, shorter total procedure time, and a wider working channel for adequate tissue sampling. SAMBA is better than DC with regard to intraductal stability and accessibility of the intrahepatic bile ducts.
authors.affiliation: Department of Internal Medicine II, Dr Horst Schmidt Klinik, (Medical School of the University of Mainz), Wiesbaden, Germany.
authors.forename: Juergen
authors.initials: J
authors.lastname: Pohl
authors.forename: Volker C
authors.initials: VC
authors.lastname: Meves
authors.forename: Gerhard
authors.initials: G
authors.lastname: Mayer
authors.forename: Angelika
authors.initials: A
authors.lastname: Behrens
authors.forename: Eckart
authors.initials: E
authors.lastname: Frimberger
authors.forename: Christian
authors.initials: C
authors.lastname: Ell
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001649:Bile Duct Diseases / Q000175:diagnosis* / Q000473:pathology / Q000601:surgery; D001650:Bile Duct Neoplasms / Q000175:diagnosis / Q000473:pathology / Q000601:surgery; D001706:Biopsy; D003251:Constriction, Pathologic / Q000175:diagnosis; D020698:Duodenoscopes; D016145:Endoscopy, Digestive System / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D020699:Gastroscopes; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D055815:Young Adult
keywords: CBD; DC; ERC; SAMBA; common bile duct; direct cholangioscopy; endoscopic retrograde cholangiography; short-access mother-baby cholangioscopy