Endoscopic balloon sphincteroplasty (papillary dilation) for bile duct stones: efficacy, safety, and follow-up in 100 patients.
BACKGROUND: Because sphincterotomy accounts for a major portion of the morbidity and mortality associated with ERCP, we have proposed endoscopic balloon papillary dilation or sphincteroplasty as an alternative. METHODS: We report the outcome in a series of 100 patients in whom balloon sphincteroplasty was attempted for bile duct stones up to 20 mm in diameter, with a median follow-up of 16 months (range 6 to 30). RESULTS: During one ERCP session using sphincteroplasty alone, the bile duct was cleared in 78%, mechanical lithotripsy being required in 10% for stones greater than 12 mm in diameter. Incomplete duct clearance was achieved in a further 4%, all of whom underwent repeat ERCP with successful duct clearance without recourse to sphincterotomy. Failure to clear the bile duct with sphincteroplasty in the remaining 18% was primarily related to large stone size ( > 15 mm). Sphincterotomy was required to clear the duct in 7%. Another 6% comprised elderly high-risk patients with multiple large stones greater than 15 mm who were treated by stent insertion plus ursodeoxycholic acid. No papillary hemorrhage was observed; uncomplicated pancreatitis occurred in 5%. During a median follow-up of 16 months, 2% had recurrent symptomatic bile duct stones considered to have been unrecognized following the initial ERCP: these were removed after repeat sphincteroplasty. No clinical evidence of papillary stenosis was observed during follow-up. CONCLUSIONS: Endoscopic balloon papillary dilation or sphincteroplasty is a safe and effective alternative to sphincterotomy in the management of bile duct stones less than 12 mm; larger stones may require mechanical lithotripsy to facilitate duct clearance.