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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 
 GUT AND LIVER, Vol.11(4) : 567-573, 2017 
Journal Title
Issue Date
Aged ; Antineoplastic Agents, Phytogenic/administration & dosage* ; Bile Duct Neoplasms/complications ; Bile Duct Neoplasms/drug therapy* ; Cholestasis/drug therapy ; Cholestasis/etiology ; Cholestasis/surgery* ; Drug-Eluting Stents* ; Early Termination of Clinical Trials ; Female ; Humans ; Male ; Metals ; Middle Aged ; Paclitaxel/administration & dosage* ; Poloxamer/therapeutic use ; Prospective Studies ; Surface-Active Agents/therapeutic use ; Treatment Outcome
Biliary tract neoplasms ; Drug-eluting stents ; Pancreatic neopla는 ; Self expandable metallic stents
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.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Yoon, Hong Jin(윤홍진) ORCID logo https://orcid.org/0000-0002-4880-3262
Lee, Dong Ki(이동기) ORCID logo https://orcid.org/0000-0002-0048-9112
Lee, Se Joon(이세준) ORCID logo https://orcid.org/0000-0002-2695-2670
Jang, Sung Ill(장성일) ORCID logo https://orcid.org/0000-0003-4937-6167
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