Abstract
Background/Aims: A drug-eluting stent for unresectable malignant biliary obstruction was developed to increase stent patency by preventing tumor ingrowth. The safety and efficacy of a new generation of metallic stents covered with a paclitaxel-incorporated membrane using a Pluronic® mixture (MSCPM-II) were compared prospectively with those of covered metal stents (CMSs) in patients with malignant biliary obstructions. Methods: This study was initially designed as a prospective randomized trial but was closed early because of a high incidence of early occlusion. Therefore, the data were analyzed using the intent-to-treat method. A total of 72 patients with unresectable distal malignant biliary obstructions were prospectively enrolled. Results: The two groups did not differ significantly in basic characteristics and mean followup period (MSCPM-II 194 days vs CMS 277 days, p=0.063). Stent occlusion occurred in 14 patients (35%) who received MSCPM-II and in seven patients (21.9%) who received CMSs. Stent patency and survival time did not significantly differ between the two groups (p=0.355 and p=0.570). The complications were mild and resolved by conservative management in both groups. Conclusions: There were no significant differences in stent patency or patient survival in MSCPM-II and CMS patients with malignant biliary obstructions.
Original language | English |
---|---|
Pages (from-to) | 567-573 |
Number of pages | 7 |
Journal | Gut and liver |
Volume | 11 |
Issue number | 4 |
DOIs | |
Publication status | Published - 2017 Jul |
All Science Journal Classification (ASJC) codes
- Hepatology
- Gastroenterology