Ofloxacin and ursodeoxycholic acid versus ursodeoxycholic acid alone to prevent occlusion of biliary stents: A prospective, randomized trial

Background and Study Aims: Biliary plastic stents are highly effective in t he treatment of malignant biliary obstruction, but may become occluded over time, leading to jaundice and cholangitis, Stent occlusion is thought to b e caused by bacterial adhesion and formation of biofilm, This study was car ried out to assess whether treatment with ofloxacin in combination with urs odeoxycholic acid is superior to ursodeoxycholic acid alone in preventing s tent occlusion. Patients and Methods: Patients with obstructive jaundice due to inoperable malignant disease underwent placement of a straight 11.5-Fr polyethylene st ent. After stent insertion, the patients were randomly assigned to receive either ofloxacin (200 mg b.i.d.) with ursodeoxycholic acid (250mg t.i.d.) o r ursodeoxycholic acid alone. The end points of the study were the frequenc y of stent occlusions, the time to stent occlusion, and the safety of the t wo regimens. Results: Fifty-two patients were enrolled, of whom 26 were assigned to the combined therapy group and 26 to the control group. Thirty patients were su ffering from pancreatic cancer, 13 from gallbladder or bile duct cancer, an d nine had metastases from other malignant tumors, Eight stent occlusions ( 31%) occurred in the ofloxacin group and six (23%) in the control group (P = 0.76). The mean times to stent occlusion were 95 +/- 9 days and 101 +/- 9 days, respectively (P = 0.91). No significant differences regarding surviv al time or safety were observed between the two groups. Conclusions: Ofloxacin in combination with ursodeoxycholic acid is not supe rior to ursodeoxycholic acid alone in preventing stent occlusion in patient s with malignant obstructive jaundice.