Drug eluting biliary stents to decrease stent failure rates: A review of the literature

Table 5 Studies evaluating drug elution or coating to prevent external failure

Ref.	Journal	Study design	Study results
Animals
Lee et al[38]	Gastrointestinal Endoscopy (2005)	Porcine model	Paclitaxel-eluting stents caused mild adverse effects, but are safe to use in porcine models
		2 pigs - control (metallic)
		2 pigs - 10% wt/v Paclitaxel
		2 pigs - 20% wt/v Paclitaxel
Lee et al[40]	Gastrointestinal Endoscopy (2009)	Canine model	Paclitaxel-eluting stents caused mild adverse effects, but are safe to use in canine models
		5 dogs - control (metallic)
		6 dogs - 20% wt/v paclitaxel
Lee et al[44]	International Journal of Pharmaceutics (2012)	In vitro, murine model	Stents coated with gemcitabine reduced the size of subcutaneous tumor in vitro and in mice
		5 mice - no stenting
		5 mice - polyurethane
		5 mice - 0% wt/v gemcitabine
		5 mice - 8% wt/v gemcitabine
		5 mice - 12% wt/v gemcitabine
Chung et al[45]	Journal of Gastroenterology and Hepatology (2012)	Porcine model	Gemcitabine-eluting stents cause mild to severe inflammation, but are safe to use in porcine models
		2 pigs - 0% wt/v gemcitabine
		2 pigs - 10% wt/v gemcitabine
		2 pigs - 15% wt/v gemcitabine
		2 pigs - 20% wt/v gemcitabine
Jang et al[41]	Endoscopy (2012)	Porcine model	Greater patency observed when stents were coated with pluronic with paclitaxel. Stents are safe to use in porcine models
		2 pigs - 0% wt/v paclitaxel
		2 pigs - 0% Pluronic + 10% taxol
		2 pigs - 10% Pluronic + 10% taxol
		2 pigs - 20% Pluronic + 10% taxol
Kim do et al[46]	International Journal of Nanomedicine (2013)	In vitro, murine model	Sorafenib-loaded film inhibited the growth of human cholangiocarcinoma cells in vitro and in mice
		10 mice - control (no stenting)
		10 mice - PCL film
		10 mice - sorafenib-loaded film
Shi et al[42]	European Journal of Gastroenterology and Hepatology (2013)	Canine model	No adverse effects
		10 dogs - control (no stenting)	less granulation tissue and glandular hyperplasia in dogs with paclitaxel stents
		10 dogs - Poly-L-lactic acid coated metallic stents (PLLA)
		10 dogs - PLLA + 1 mg paclitaxel/stent
		10 dogs - PLLA + 2 mg paclitaxel/stent
Bang et al[43]	Gastroenterology Research and Practice (2015)	Murine model	Tumor angiogenesis inhibited in mice with Paclitaxel stents through multiple molecular mechanisms
		8 mice - control (polyurethane)
		8 mice - control + Pluronic
		8 mice - Pluronic + 5% paclitaxel
		8 mice - Pluronic + 10% paclitaxel
Humans
Suk et al[2]	Gastrointestinal Endoscopy (2007)	Randomized prospective	Paclitaxel-eluting stents are safe and effective. Occlusion in 9 patients, mean patency was 429 d
		21 patients - 10% wt/v paclitaxel
Jang et al[3]	Digestive Diseases and Sciences (2013)	Randomized prospective	No significant differences in stent patency or patient survival, but stents proved safe to use in humans
		46 patients - control (metallic)
		60 patients - 10% wt/v paclitaxel