Covered and uncovered self-expandable metallic Hanarostents are equally efficacious in the drainage of extrahepatic malignant strictures. Results of a double-blind randomized study.

BACKGROUND

Self-expandable metallic stents (SEMS) placement is a standard treatment for inoperable malignant bile duct strictures. Covered SEMS have been introduced to avoid stent occlusion by tumor ingrowth. The aims were to compare covered and uncovered stents in terms of patency, efficacy and complication rate.

MATERIAL AND METHODS

Consecutive patients with inoperable malignant distal biliary strictures were included in the study and randomized to receive a covered (n = 34) or uncovered (n = 34) Hanaro SEMS. Follow-up was performed by nurses after 18 h, 48 h, 2 weeks and thereafter every month until stent dysfunction or the patient died. Outcomes were measured as follows: the patients reported urine and stool color, presence of fever and abdominal pain. Liver function tests and CRP were analyzed each time. The procedure time and complications were monitored. The follow-up was blinded to stent type.

RESULTS

The median patient age was 79 years (IQR: 66-83, R: 54-92), 59% were female and 85% had the gallbladder in situ. There was no difference between covered and uncovered stents in terms of procedure time (median: 30 min (20-38, R: 12-90) vs. 30 min (IQR: 20-42, R: 12-70)), stent patency (median: 153 days (IQR: 65-217; R: 20-609) vs. median of 127 days (IQR: 70-196; R: 18-486)) or patient survival (median: 154 days (IQR: 65-217; R: 21-609) vs 157 days (IQR: 70-273, R: 20-690)). Eighty-seven percent died with a patent covered and 83% with an uncovered stent (n.s.). Two early complications occurred (sepsis; pancreatitis), both with covered stents.

CONCLUSION

There is no clinical difference between covered and uncovered biliary Hanaro SEMS. Both types are easily inserted with low complication rate and have long-term patency.