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Safety Evaluation of Paclitaxel-Eluting Biliary Metal Stent with Sodium Caprate in Porcine Biliary Tract
- Source :
- Gut and Liver
- Publication Year :
- 2019
- Publisher :
- The Editorial Office of Gut and Liver, 2019.
-
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.
- Subjects :
- medicine.medical_specialty
Paclitaxel
Swine
medicine.medical_treatment
Sus scrofa
Self Expandable Metallic Stents
Gastroenterology
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Self-expandable metallic stent
Neoplasms
Internal medicine
medicine
Animals
Aspartate Aminotransferases
Pancreatic neoplasm
Serum Albumin
Common Bile Duct
Biliary tract neoplasm
Cholestasis
Hepatology
biology
business.industry
Bile duct
Stent
Alanine Transaminase
Drug-Eluting Stents
Alkaline Phosphatase
Antineoplastic Agents, Phytogenic
Drug delivery systems
medicine.anatomical_structure
Self expandable metallic stent
Alanine transaminase
chemistry
Drug-eluting stent
Biliary tract
030220 oncology & carcinogenesis
biology.protein
Original Article
030211 gastroenterology & hepatology
business
Decanoic Acids
Biliary tract neoplasms
Subjects
Details
- ISSN :
- 20051212 and 19762283
- Volume :
- 13
- Database :
- OpenAIRE
- Journal :
- Gut and Liver
- Accession number :
- edsair.doi.dedup.....a43c782896c492d38729bd669511e2ca