The role of ciprofloxacin in prolonging polyethylene biliary stent patency: a multicenter, double-blinded effectiveness study.

Plastic stents are the mainstay of the palliation of malignant jaundice but are complicated by recurrent obstruction. Previous trials have failed to demonstrate any improvement in patency with the use of antibiotics. Patients with malignant jaundice were randomized in a double-blind fashion, after polyethylene stent insertion, to receive ciprofloxacin or placebo. After successful stent decompression, there were 50 patients in the treatment arm and 44 in the placebo. There were 14 (33%) episodes of stent occlusion in the ciprofloxacin group versus 23 (49%) in placebo (chi(2) test, P=0.115). There was no significant difference in patency (log-rank test, P=0.17). There were significantly fewer episodes of cholangitis with ciprofloxacin: 10 (23%) versus 21 (42%) in the placebo (P=0.047). The ciprofloxacin group also demonstrated a significant improvement in the Social Function domain of the SF-36 Quality of Life Survey at 1 month (paired T test, P=0.03). The other domains of the SF-36 were not different, nor was survival (log rank, P=0.80). There is insufficient evidence to show that prophylactic ciprofloxacin can prolong plastic biliary stent patency. The observed trends suggest that ciprofloxacin significantly decreases the incidence of cholangitis and results in improvements in certain aspects of quality of life.

RCT Entities:   Population Interventions Outcomes