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Efficacy of a Metallic Stent Covered with a Paclitaxel-Incorporated Membrane Versus a Covered Metal Stent for Malignant Biliary Obstruction: A Prospective Comparative Study

 Sung Ill Jang  ;  Jie-Hyun Kim  ;  Jung Whan You  ;  Kwangwon Rhee  ;  Se Joon Lee  ;  Ho Gak Kim  ;  Jimin Han  ;  Im Hee Shin  ;  Sang-Heum Park  ;  Dong Ki Lee 
 DIGESTIVE DISEASES AND SCIENCES, Vol.58(3) : 865-871, 2013 
Journal Title
Issue Date
Aged ; Aged, 80 and over ; Antineoplastic Agents, Phytogenic/administration & dosage* ; Antineoplastic Agents, Phytogenic/therapeutic use ; Cholestasis/etiology* ; Cholestasis/therapy* ; Drug-Eluting Stents* ; Female ; Gastrointestinal Neoplasms/complications* ; Gastrointestinal Neoplasms/pathology ; Humans ; Male ; Middle Aged ; Paclitaxel/administration & dosage* ; Paclitaxel/therapeutic use
Paclitaxel ; Drug-eluting stent ; Biliary tract neoplasm ; Malignant obstruction ; Pancreatic cancer
BACKGROUND: The placement of a self-expandable metallic stent (SEMS) is a widely used nonsurgical treatment method in patients with unresectable malignant biliary obstructions but SEMS is susceptible to occlusion by tumor ingrowth or overgrowth. AIM: The efficacy and safety of a metallic stent covered with a paclitaxel-incorporated membrane (MSCPM) in which paclitaxel provided an antitumoral effect was compared prospectively with those of a covered metal stent (CMS) in patients with malignant biliary obstructions. METHODS: Patients with unresectable distal malignant biliary obstructions (n = 106) were prospectively enrolled in this study at multiple treatment centers. A MSCPM was inserted endoscopically in 60 patients, and a CMS was inserted in 46 patients. Patients underwent systemic chemotherapy regimens alternatively according to disease characteristics. RESULTS: The two groups did not differ significantly in mean age, male to female ratio, or mean follow-up period. Stent occlusion due to tumor ingrowth occurred in 12 patients who received MSCPMs and in eight patients who received CMSs. Stent patency and survival time did not differ significantly between the two groups (p = 0.116, 0.981). Chemotherapy had no influence on stent patency, but gemcitabine-based chemotherapy was a significant prognostic factor for survival time (p = 0.012). Complications, including cholangitis and pancreatitis, were found to be acceptable in both groups. CONCLUSIONS: Although the use of a MSCPM produced no significant differences in stent patency or patient survival in patients with malignant biliary obstructions compared with the use of a CMS, this study demonstrated that MSCPM can be used safely in humans.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Biochemistry and Molecular Biology (생화학-분자생물학교실) > 1. Journal Papers
Yonsei Authors
Kim, Jie-Hyun(김지현) ORCID logo https://orcid.org/0000-0002-9198-3326
Yu, Jung Hwan(유정환)
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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