The effect on porcine bile duct of a metallic stent covered with a paclitaxel-incorporated membrane

DongKi Lee, Hyunsoo Kim, Kyung Sik Kim, Woo Jung Lee, Ho Keun Kim, Young Hyun Won, Young Ro Byun, Moonyoung Kim, Soonkoo Baik, Sang Ok Kwon

Research output: Contribution to journalArticle

64 Citations (Scopus)

Abstract

Background: Biliary metallic stents are covered with a membrane to prevent tumor ingrowth and to prolong patency. The only function of these stents is to promote biliary drainage; they have no antitumor effect. Methods: A metallic stent was developed that is covered with a paclitaxel-incorporated membrane. The metallic stents were coated with one of 3 concentrations of paclitaxel (0, 10, and 20 % wt/v) and polyurethane. A stent with each concentration was surgically inserted in the bile duct of two pigs. Four weeks after insertion, the segment of bile duct containing the stent was examined histologically. To determine the efficacy of the drug release, stents were placed in phosphate buffered saline solution for 6 weeks, and the amount of paclitaxel released was measured by high-performance liquid chromatography. Results: The histologic changes in the pig biliary epithelium were acceptable with respect to safety and included inflammatory cell infiltration and fibrous reactions. The changes corresponded to the amount of paclitaxel incorporated within the stent in contact with the bile duct. Epithelial denudation, mucin hypersecretion, and epithelial metaplasia were noted in the bile ducts that were in contact with stents containing 20 % wt/v paclitaxel. Transmural necrosis and perforation were not observed in any animal. In the in vitro experiment, the amounts of paclitaxel released over 1 week and over 6 weeks were similar, regardless of the concentration of paclitaxel incorporated in the stent. The stent with 10% (wt/v) paclitaxel in the covering membrane was found to be better than that with 20 % (wt/v) with respect to histologic changes and the effectiveness of drug release. Conclusions: A paclitaxel-incorporated metallic stent could serve as a basis for the development of a new and safe treatment modality for malignant biliary obstruction. Clinical trials of this stent with other adjuvant therapy are warranted.

Original languageEnglish
Pages (from-to)296-301
Number of pages6
JournalGastrointestinal Endoscopy
Volume61
Issue number2
DOIs
Publication statusPublished - 2005 Feb 1

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Paclitaxel
Bile Ducts
Stents
Swine
Membranes
Polyurethanes
Metaplasia
Mucins
Sodium Chloride
Drainage
Necrosis
Epithelium
Phosphates
High Pressure Liquid Chromatography
Clinical Trials

All Science Journal Classification (ASJC) codes

  • Radiology Nuclear Medicine and imaging
  • Gastroenterology

Cite this

Lee, DongKi ; Kim, Hyunsoo ; Kim, Kyung Sik ; Lee, Woo Jung ; Kim, Ho Keun ; Won, Young Hyun ; Byun, Young Ro ; Kim, Moonyoung ; Baik, Soonkoo ; Kwon, Sang Ok. / The effect on porcine bile duct of a metallic stent covered with a paclitaxel-incorporated membrane. In: Gastrointestinal Endoscopy. 2005 ; Vol. 61, No. 2. pp. 296-301.
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abstract = "Background: Biliary metallic stents are covered with a membrane to prevent tumor ingrowth and to prolong patency. The only function of these stents is to promote biliary drainage; they have no antitumor effect. Methods: A metallic stent was developed that is covered with a paclitaxel-incorporated membrane. The metallic stents were coated with one of 3 concentrations of paclitaxel (0, 10, and 20 {\%} wt/v) and polyurethane. A stent with each concentration was surgically inserted in the bile duct of two pigs. Four weeks after insertion, the segment of bile duct containing the stent was examined histologically. To determine the efficacy of the drug release, stents were placed in phosphate buffered saline solution for 6 weeks, and the amount of paclitaxel released was measured by high-performance liquid chromatography. Results: The histologic changes in the pig biliary epithelium were acceptable with respect to safety and included inflammatory cell infiltration and fibrous reactions. The changes corresponded to the amount of paclitaxel incorporated within the stent in contact with the bile duct. Epithelial denudation, mucin hypersecretion, and epithelial metaplasia were noted in the bile ducts that were in contact with stents containing 20 {\%} wt/v paclitaxel. Transmural necrosis and perforation were not observed in any animal. In the in vitro experiment, the amounts of paclitaxel released over 1 week and over 6 weeks were similar, regardless of the concentration of paclitaxel incorporated in the stent. The stent with 10{\%} (wt/v) paclitaxel in the covering membrane was found to be better than that with 20 {\%} (wt/v) with respect to histologic changes and the effectiveness of drug release. Conclusions: A paclitaxel-incorporated metallic stent could serve as a basis for the development of a new and safe treatment modality for malignant biliary obstruction. Clinical trials of this stent with other adjuvant therapy are warranted.",
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The effect on porcine bile duct of a metallic stent covered with a paclitaxel-incorporated membrane. / Lee, DongKi; Kim, Hyunsoo; Kim, Kyung Sik; Lee, Woo Jung; Kim, Ho Keun; Won, Young Hyun; Byun, Young Ro; Kim, Moonyoung; Baik, Soonkoo; Kwon, Sang Ok.

In: Gastrointestinal Endoscopy, Vol. 61, No. 2, 01.02.2005, p. 296-301.

Research output: Contribution to journalArticle

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T1 - The effect on porcine bile duct of a metallic stent covered with a paclitaxel-incorporated membrane

AU - Lee, DongKi

AU - Kim, Hyunsoo

AU - Kim, Kyung Sik

AU - Lee, Woo Jung

AU - Kim, Ho Keun

AU - Won, Young Hyun

AU - Byun, Young Ro

AU - Kim, Moonyoung

AU - Baik, Soonkoo

AU - Kwon, Sang Ok

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N2 - Background: Biliary metallic stents are covered with a membrane to prevent tumor ingrowth and to prolong patency. The only function of these stents is to promote biliary drainage; they have no antitumor effect. Methods: A metallic stent was developed that is covered with a paclitaxel-incorporated membrane. The metallic stents were coated with one of 3 concentrations of paclitaxel (0, 10, and 20 % wt/v) and polyurethane. A stent with each concentration was surgically inserted in the bile duct of two pigs. Four weeks after insertion, the segment of bile duct containing the stent was examined histologically. To determine the efficacy of the drug release, stents were placed in phosphate buffered saline solution for 6 weeks, and the amount of paclitaxel released was measured by high-performance liquid chromatography. Results: The histologic changes in the pig biliary epithelium were acceptable with respect to safety and included inflammatory cell infiltration and fibrous reactions. The changes corresponded to the amount of paclitaxel incorporated within the stent in contact with the bile duct. Epithelial denudation, mucin hypersecretion, and epithelial metaplasia were noted in the bile ducts that were in contact with stents containing 20 % wt/v paclitaxel. Transmural necrosis and perforation were not observed in any animal. In the in vitro experiment, the amounts of paclitaxel released over 1 week and over 6 weeks were similar, regardless of the concentration of paclitaxel incorporated in the stent. The stent with 10% (wt/v) paclitaxel in the covering membrane was found to be better than that with 20 % (wt/v) with respect to histologic changes and the effectiveness of drug release. Conclusions: A paclitaxel-incorporated metallic stent could serve as a basis for the development of a new and safe treatment modality for malignant biliary obstruction. Clinical trials of this stent with other adjuvant therapy are warranted.

AB - Background: Biliary metallic stents are covered with a membrane to prevent tumor ingrowth and to prolong patency. The only function of these stents is to promote biliary drainage; they have no antitumor effect. Methods: A metallic stent was developed that is covered with a paclitaxel-incorporated membrane. The metallic stents were coated with one of 3 concentrations of paclitaxel (0, 10, and 20 % wt/v) and polyurethane. A stent with each concentration was surgically inserted in the bile duct of two pigs. Four weeks after insertion, the segment of bile duct containing the stent was examined histologically. To determine the efficacy of the drug release, stents were placed in phosphate buffered saline solution for 6 weeks, and the amount of paclitaxel released was measured by high-performance liquid chromatography. Results: The histologic changes in the pig biliary epithelium were acceptable with respect to safety and included inflammatory cell infiltration and fibrous reactions. The changes corresponded to the amount of paclitaxel incorporated within the stent in contact with the bile duct. Epithelial denudation, mucin hypersecretion, and epithelial metaplasia were noted in the bile ducts that were in contact with stents containing 20 % wt/v paclitaxel. Transmural necrosis and perforation were not observed in any animal. In the in vitro experiment, the amounts of paclitaxel released over 1 week and over 6 weeks were similar, regardless of the concentration of paclitaxel incorporated in the stent. The stent with 10% (wt/v) paclitaxel in the covering membrane was found to be better than that with 20 % (wt/v) with respect to histologic changes and the effectiveness of drug release. Conclusions: A paclitaxel-incorporated metallic stent could serve as a basis for the development of a new and safe treatment modality for malignant biliary obstruction. Clinical trials of this stent with other adjuvant therapy are warranted.

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