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. DESIGN: Prospective clinical evaluation. INTERVENTIONS: 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. MAIN OUTCOME MEASUREMENTS 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. LIMITATIONS: This was a single-centre, uncontrolled study. CONCLUSION: 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.