Permanent stenting in "unextractable" common bile duct stones in high risk patients. A prospective randomized study comparing two different stents.

BACKGROUND: Endoscopic sphincterotomy (ES) and stone extraction is the treatment of choice for bile duct stones. Therefore, if ES and conventional stone extraction fail, further treatment is mandatory. Insertion of a biliary endoprosthesis is an effective option. MATERIALS AND METHODS: We treated 30 high-risk patients (17 women and 13 men, mean age 82 years) affected by difficult common bile duct stones. The patients were randomly assigned preoperatively using closed envelopes (blind randomization) into two groups to receive insertion of polyethylene or hydrophilic hydromer-coated polyurethane stent, respectively. Follow-up was achieved by contacting referring physicians and patient's relatives. RESULTS: Biliary drainage was established in all patients. Early minor complications occurred in 28%. In all these patients, the stent was a definitive measure. Median follow-up was 38 months. Late complications occurred in 34%. Cholangitis was the most frequent. During follow up, 11 patients died, two as result of a biliary-related cause. No statistically significant difference was observed on different stents patency. CONCLUSION: Endoprosthesis insertion as a permanent therapy is an effective alternative to surgery or dissolution therapy. Therefore, biliary stenting should preferably be restricted to high-risk patients unfit for operative treatment and with a short life expectancy.