The Effectiveness of Ciprofloxacin in Prolonging Plastic Biliary Stent Patency: A Randomized Controlled Trial

Abstract

Background: Endoscopically-placed stents are the mainstay of the palliation of malignant biliary obstruction, but are complicated by obstruction, return of jaundice and cholangitis. Several trials have failed to consistently demonstrate an improvement in the duration of polyethylene stent patency with ongoing antibiotic treatment. Generally, these studies have lacked sufficient statistical power. Aim: To study the effect of ciprofloxacin treatment on stent patency and on the perceived patient's quality of life. Methods: Patients with obstructive jaundice from an unresectable malignancy were randomized in a double-masked fashion after successful polyethylene biliary stent insertion, to receive ciprofloxacin (500 mg PO BID) or placebo (one tablet PO BID) until stent blockage. Results: A total of 135 patients were recruited from three tertiary care institutions. The two groups were comparable in terms of age (72.7 ± 10.4 yrs.), gender (54% F), initial symptomatology, diagnosis, staging of the tumor, site of obstruction, liver enzymes, and bilirubin (265.6 ± 147.0 μmol/L). Thirty-four were excluded from final analysis because of: drop-out prior to the 7-day follow-up (16), inadequate early drop in bilirubin (18). There were 26 episodes of stent occlusion in the placebo group (43%) and 20 episodes in the Ciprofloxacin group (34%). The mean time to blockage was 61.2 ± 68.0 days in the placebo group and 83.3 ± 117.9 days in the treatment group. On survival analysis, there was no significant difference in the duration of patency between the two groups by log-rank test, (p=0.17). SF-36 Health Survey at baseline and one month were used to quantify any change in patient quality of life. The ciprofloxacin group demonstrated a significant decrease in the Social Function domain at one month compared to the placebo group (p=0.03). Conclusion: We conclude that the use of ciprofloxacin does not prolong biliary stent patency in malignant obstruction, and may even be associated with a decrease in the quality of life of these patients.