title: Efficacy of a metallic stent covered with a paclitaxel-incorporated membrane versus a covered metal stent for malignant biliary obstruction: a prospective comparative study.
abstract: 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.
  
  
  OBJECTIVE
  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.
authors.affiliation: Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, 712 Eonjuro, Gangnam-gu, Seoul, 135-720, Korea.
authors.forename: Sung Ill
authors.initials: SI
authors.lastname: Jang
authors.forename: Jie-Hyun
authors.initials: JH
authors.lastname: Kim
authors.forename: Jung Whan
authors.initials: JW
authors.lastname: You
authors.forename: Kwangwon
authors.initials: K
authors.lastname: Rhee
authors.forename: Se Joon
authors.initials: SJ
authors.lastname: Lee
authors.forename: Ho Gak
authors.initials: HG
authors.lastname: Kim
authors.forename: Jimin
authors.initials: J
authors.lastname: Han
authors.forename: Im Hee
authors.initials: IH
authors.lastname: Shin
authors.forename: Sang-Heum
authors.initials: SH
authors.lastname: Park
authors.forename: Dong Ki
authors.initials: DK
authors.lastname: Lee
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000627:therapeutic use; D002779:Cholestasis / Q000209:etiology* / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D005770:Gastrointestinal Neoplasms / Q000150:complications* / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000627:therapeutic use
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel