Efficacy of a multiplex paclitaxel emission stent using a Pluronic® mixture membrane versus a covered metal stent in malignant biliary obstruction: A prospective randomized comparative study

Sung Ill Jang, Se Joon Lee, Seok Jeong, Don Haeng Lee, Myung Hwan Kim, Hong Jin Yoon, Dong Ki Lee

Research output: Contribution to journalArticle

12 Citations (Scopus)

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 languageEnglish
Pages (from-to)567-573
Number of pages7
JournalGut and liver
Volume11
Issue number4
DOIs
Publication statusPublished - 2017 Jul

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Gastroenterology

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