Randomised trial of endoscopic stenting versus surgical bypass in malignant low bileduct obstruction. Long-term ciprofloxacin treatment for the prevention of biliary stent blockage: a prospective randomized study.
The development of non-surgical techniques for the relief of malignant low bileduct obstruction has cast doubt on the best way of relieving jaundice, particularly in patients fit for surgery whose life expectancy is more than a few weeks. We did a randomised prospective controlled trial comparing endoscopic stent insertion and surgical biliary bypass in patients with malignant low bileduct obstruction. 204 patients were randomised (surgery 103, stent 101); 3 subsequently proved to have benign disease and were excluded, leaving 101 surgical and 100 stented patients for assessment. Technical success was achieved in 94 surgical and 95 stented patients, with functional biliary decompression obtained in 92 patients in both groups. In stented patients, there was a lower procedure-related mortality (3% vs 14%, p = 0.01), major complication rate (11% vs 29%, p = 0.02), and median total hospital stay (20 vs 26 days, p = 0.001). Recurrent jaundice occurred in 36 stented patients and 2 surgical patients. Late gastric outlet obstruction occurred in 17% of stented patients and 7% of the surgical group. Despite the early benefits of stenting there was no significant difference in overall survival between the two groups (median survival: surgical 26 weeks; stented 21 weeks; p = 0.065). Endoscopic stenting and surgery are effective palliative treatments with the former having fewer early treatment-related complications and the latter fewer late complications. 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.
                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.
                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.
                Long-term use of ciprofloxacin does not prevent blockage of polyethylene biliary stents.
We could not find convincing evidence to support or refute endoscopic biliary stenting on the mortality in patients with pancreatico-biliary malignancy. Large randomised trials are needed to settle the question of pre-surgical biliary stenting.