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

Abstract

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.

Key Words::

• covered
• endoscopy
• obstructive jaundice
• palliative treatment
• stent
• uncovered

Acknowledgements

The study was supported by grants from the R&D Council in Western Götaland Region, the Faculty of Medicine and the Faculty of Surgery, University of Gothenburg. My Engstöm, Lars Rydberg, Anders Kylebäck and Anders Kilander contributed to the study.

Declaration of interest: The study was supported with a grant of SEK 30.000 from Olympus Sweden, the agent that sells Hanarostents in Sweden. This grant was used by Dr Kjell-Arne Ung to attend UEGW in London and a national Swedish congress. Dr Ung has no other conflicts of interest or financial ties to disclose. Dr Per-Ove Stotzer, Dr Erik Johnsson, Åsa Nilsson RN and Marie-Louise Gustavsson RN have no conflict of interest or financial ties to disclose.