Clinical Trial
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Multicenter Study
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Endoscopic papillary balloon dilation for bile duct stone: immediate and long-term outcomes in 1000 patients.

BACKGROUND & AIMS: The long-term outcomes of endoscopic papillary balloon dilation (EPBD) for bile duct stone removal are not well known.

METHODS: A total of 1000 patients with bile duct stones were treated with EPBD. After assessing immediate outcomes, patients were followed up for late biliary complications.

RESULTS: Complete bile duct clearance was achieved with EPBD alone in 963 patients (96.3%) in a mean of 1.5 endoscopic sessions. Post-EPBD pancreatitis developed in 48 patients (4.8%), including 1 patient graded as severe. The long-term outcome was evaluated in 837 patients with a mean follow-up period of 4.4 years. Biliary complications were seen in 104 patients (12.4%), and they were less frequent in the cholecystectomy (CCx) after EPBD group than in the gallbladder (GB) left in situ with stones, GB left in situ without stones, and CCx before EPBD groups (2.8% vs 22.6%, 9.2%, and 13.5%, respectively). Stone recurrence was seen in 74 patients (8.8%)--2.4%, 15.6%, 5.9%, and 10.8% in the CCx after EPBD, GB left in situ with stones, GB left in situ without stones, and CCx before EPBD groups, respectively. Lithotripsy and gallbladder status were identified as risk factors for stone recurrence. Cholecystitis occurred in 13 patients (4.5%) in the GB left in situ with stones group.

CONCLUSIONS: EPBD was effective in treating bile duct stones that were not accompanied by an unacceptably high risk of pancreatitis. Patients with calculous gallbladder had the highest risk for late complications, and cholecystectomy is recommended after removal of their bile duct stones.

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