title: Safety and efficacy of a newly developed baby-sphincterotome for cannulation and precut in cases of failed selective wire-guided bile duct access:  a prospective 8-year clinical evaluation.
abstract: BACKGROUND
  Precut sphincterotomy (PCS) is a well-established alternative after repeated unsuccessful attempts of common bile duct (CBD) cannulation using standard catheters and/or guide-wire. Commonly used instruments for precutting are the needle-knife and a modified traction-type sphincterotome. In 1996, a so-called 'baby-sphincterotome' with a preshaped, small-caliber 3 Fr tip was developed, which enables cannulation and precutting in one step.
  
  
  OBJECTIVE
  A clinical evaluation was carried out and the complication rates were determined at a tertiary referral hospital.
  
  
  METHODS
  Prospective clinical evaluation.
  
  
  METHODS
  During an 8-year period, a total of 5389 endoscopic retrograde cholangiopancreatographies were performed at our hospital. In total, 1886 patients fulfilled the inclusion criteria for this prospective study. The baby-sphincterotome was used in 345 of 1886 patients (mean age 63.4 ± 16.4 years, 203 women) after five unsuccessful attempts of CBD cannulation using a hydrophilic guide-wire. After two more failed CBD cannulations with the baby-sphincterotome, PCS was performed using the same device.
  
  
  METHODS
  The success rates of biliary access, postendoscopic retrograde cholangiopancreatography pancreatitis, and bleeding were assessed.
  
  
  RESULTS
  Initially, the success rate of CBD cannulation on using the baby-sphincterotome was 28% (96/345 patients). Postinterventional pancreatitis occurred in two of 96 patients (2%) and minor bleeding occurred during traction-type sphincterotomy in four of 93 patients (4%). In the remaining 249 patients precut with a baby-sphincterotome, CBD cannulation was achieved in 219 cases (88%), although with pancreatitis and severe bleeding in 4% each. In 30 of 249 patients (12%), a second or a third (n=5) intervention was necessary, with a success rate of 73% (22/30 cases) after PCS.
  
  
  CONCLUSIONS
  This was a single-centre, uncontrolled study.
  
  
  CONCLUSIONS
  The newly developed baby-sphincterotome enables bile duct access in a single session in 91% of the patients when guide-wire cannulation has failed. Direct cannulation was possible in about one-quarter of the patients, whereas PCS with the new device showed a high efficacy and a low complication rate.
authors.affiliation: Department of Medicine, Ruhr University, Bochum, Germany. ariphaus@web.de
authors.forename: Andrea
authors.initials: A
authors.lastname: Riphaus
authors.forename: Patrizia Am
authors.initials: PA
authors.lastname: Weg
authors.forename: Hans
authors.initials: H
authors.lastname: Seifert
authors.forename: Till
authors.initials: T
authors.lastname: Wehrmann
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D042883:Choledocholithiasis / Q000000981:diagnostic imaging / Q000601:surgery; D002779:Cholestasis / Q000000981:diagnostic imaging / Q000601:surgery; D003137:Common Bile Duct Diseases / Q000000981:diagnostic imaging / Q000601:surgery*; D004867:Equipment Design; D005260:Female; D006470:Hemorrhage / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016717:Sphincterotomy, Endoscopic / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D017211:Treatment Failure; D016896:Treatment Outcome; D055815:Young Adult