CLINICAL TRIAL
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
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Long-term ciprofloxacin treatment for the prevention of biliary stent blockage: a prospective randomized study.

OBJECTIVE: In vitro experimental and animal studies have shown that quinolones reduce the adherence of bacteria on a polyethylene tube and prevent stent blockage. Our aim was to see whether ciprofloxacin prevents stent blockage in patients with malignant stricture of the biliary tract.

METHODS: Patients with inoperable biliary or pancreatic tumor not involving the bifurcation of the common hepatic duct were recruited. They were randomized to receive either endoscopic stenting alone or stenting with prophylactic treatment of ciprofloxacin (200 mg i.v. before stenting, followed by 250 mg orally twice per day). In each follow-up visit, clinical symptoms of cholangitis were documented and blood samples taken for blood counts, serum levels of bilirubin, and alkaline phosphatase. Stent blockage was defined as clinical symptom(s) of cholangitis with biochemical or radiological evidence of stent dysfunction.

RESULTS: Fifty-eight patients were recruited into the study. Three patients in the stenting group and three in the ciprofloxacin group were excluded after randomization. Eleven patients received stenting alone and five patients receiving ciprofloxacin had previous endoscopic stenting. Thirteen patients (50%) in the ciprofloxacin group and eight patients (31%) in the stenting group died before stent blockage. Ten patients (38%) in each group had stent blockage during the follow-up at 20 wk. The median stent patency was 11.6 wk and 11.9 wk in the ciprofloxacin group and the stenting group, respectively. Kaplan-Meier analysis of stent patency showed no difference between the two groups. Among patients who received endoscopic stenting for the first time, there was a trend favoring ciprofloxacin treatment, but the difference was not significant. The 30-day and 20-wk mortality between the groups were comparable.

CONCLUSION: Long-term use of ciprofloxacin does not prevent blockage of polyethylene biliary stents.

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