Gut Liver.  2019 Jul;13(4):471-478. 10.5009/gnl18454.

Safety Evaluation of Paclitaxel-Eluting Biliary Metal Stent with Sodium Caprate in Porcine Biliary Tract

Affiliations
  • 1Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea. dklee@yuhs.ac
  • 2Department of Internal Medicine, Inha University Hospital, Inha University College of Medicine, Incheon, Korea.
  • 3Utah-Inha DDS &Advanced Therapeutics Research Center, Incheon, Korea.
  • 4Department of Biotechnology, The Catholic University of Korea, Bucheon, Korea.
  • 5World Class Smart Lab, Department of New Drug Development, Inha University College of Medicine, Incheon, Korea. sugeun.yang@inha.ac.kr

Abstract

BACKGROUND/AIMS
Metallic stents designed to relieve malignant biliary obstruction are susceptible to occlusive tumor ingrowth or overgrowth. In a previous report, we described metallic stents covered with paclitaxel-incorporated membrane (MSCPM-I, II) to prevent occlusion from tumor ingrowth via antitumor effect. This new generation paclitaxel-eluting biliary stent is further endowed with sodium caprate (MSCPM-III) for enhanced drug delivery. The purpose of this study is to examine the safety of its drug delivery system in the porcine biliary tract.
METHODS
MSCPM-III (10% [wt/vol] paclitaxel) and covered metal stents (CMSs) were endoscopically inserted in porcine bile ducts in vivo. Histologic biliary changes, levels of paclitaxel released, and various serum analytes (albumin, alkaline phosphate, aspartate transaminase, alanine transaminase, total protein, total bilirubin, and direct bilirubin) were assessed.
RESULTS
Based on the intensity of reactive inflammation and fibrosis, changes in porcine biliary epithelium secondary to implanted MSCPM-III were deemed acceptable (i.e., safe). Histologic features in the MSCPM-III and CMS groups did not differ significantly. In a related serum analysis, paclitaxel release from MSCPM-III stents was below the limit of detection for 28 days. Biochemical analyses were also similar for the two groups, and no evidence of hepatic or renal toxicity was found in animals receiving MSCPM-III stents.
CONCLUSIONS
In a prototypic porcine trial, this newly devised metal biliary stent incorporating both paclitaxel and sodium caprate appears to be safe in the porcine bile duct.

Keyword

Drug-eluting stent; Self expandable metallic stent; Drug delivery systems; Biliary tract neoplasms; Pancreatic neoplasm
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