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.
- Author:
Sung Ill JANG
1
;
Se Joon LEE
;
Seok JEONG
;
Don Haeng LEE
;
Myung Hwan KIM
;
Hong Jin YOON
;
Dong Ki LEE
Author Information
- Publication Type:Comparative Study ; Original Article
- Keywords: Drug-eluting stents; Biliary tract neoplasms; Pancreatic neoplasms; Self expandable metallic stents
- MeSH: Biliary Tract Neoplasms; Drug-Eluting Stents; Follow-Up Studies; Humans; Incidence; Membranes*; Methods; Paclitaxel*; Pancreatic Neoplasms; Prospective Studies*; Self Expandable Metallic Stents; Stents*
- From:Gut and Liver 2017;11(4):567-573
- CountryRepublic of Korea
- Language:English
- 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 follow-up 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.