Stent performance in palliative transhepatic treatment of malignant biliary obstruction: a randomized study comparing covered versus uncovered stents

Abstract

Background

Considering the limitations in both uncovered self-expandable metallic stents (USEMS) and covered self-expandable metallic stents (CSEMS), it is difficult to make a general recommendation for their application in percutaneous decompression of malignant biliary obstruction (MBO).

Purpose

To compare percutaneous transhepatic CSEMSs versus USEMSs for the palliative treatment of MBO in terms of technical success, clinical success, stent patency, patient survival, complications, and stent dysfunction.

Material and Methods

This prospective randomized study included 66 patients with unresectable MBO. CSEMSs were inserted in 31 patients (26 men, 5 women; mean age = 63.8 ± 7.96 years) and USEMSs were inserted in 35 patients (26 men, 9 women; mean age = 62.3 ± 11.7 years).

Results

Mean primary stent patency duration was 138 ± 92.7 days in CSEMSs versus 150 ± 77.9 days in USEMSs (P = 0.578). Tumor overgrowth occurred exclusively in one patient with CSEMS (P = 0.470) and tumor ingrowth exclusively in two patients with USEMS (P = 0.494). Stent migration occurred in two patients with CSEMSs versus one patient with USEMSs (P = 0.579). Hemobilia occurred in five patients with CSEMSs versus three patients with USEMSs while bile leakage occurred in one patient in each group despite the larger introducer sheath caliber with CSEMSs (9 F vs. 6–7 F). There was no significant difference regarding patient survival (P = 0.969).

Conclusion

In our cohort of patients with rather poor life expectancy, there was no significant difference between covered and uncovered stents for the palliative treatment of MBO. However, considering the higher cost of CSEMs and the larger introducer diameter necessary for their placement, USEMSs can be preferred.