Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00453076
Status:
COMPLETED
Last Update Posted:
2010-06-11
First Post:
2007-03-27
Brief Title:
Paclitaxel Eluting Covered Metallic Stent for Unresectable Malignant Bile Duct Obstruction
Sponsor:
Asan Medical Center
Organization:
Asan Medical Center
Study Overview
Official Title:
Randomized Trial of Conventional Covered Self Expandable Metallic Stent Versus Paclitaxel Eluting Covered Self Expandable Metallic Stent in Unresectable Malignant Bile Duct Obstruction
Status:
COMPLETED
Status Verified Date:
2006-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary goal is to determine stent patency and overall survival of the conventional covered self expandable metallic stent versus paclitaxel eluting covered self expandable metallic stent in unresectable malignant bile duct stricture
The secondary goals are to assess reinterventions complications technical difficulties and physician graded ease of placement and to assess toxicity of paclitaxel eluting covered self expandable metallic stent
The secondary goals are to assess reinterventions complications technical difficulties and physician graded ease of placement and to assess toxicity of paclitaxel eluting covered self expandable metallic stent
Detailed Description:
11 Self-expandable metallic stent SEMS Self-expandable metallic stent SEMS placement is a well-established and widely used treatment for patients with unresectable malignant biliary obstruction This palliative technique prolongs survival shortens hospital stay and improves quality of life in patients with unresectable malignant biliary obstruction Unfortunately SEMS have the disadvantage of occlusion over time because of tumor ingrowth tumor invasion through the metal wire mesh of the stent or overgrowth tumor growing at the end of the stent and mucosal hyperplasia as a consequence of chronic irritation The occlusion rate of SEMS varies from 10 to 50 of cases of malignant biliary obstruction 6-9 Duration of SEMS patency is important for patients with a short life-expectancy because quality of life and cost-effectiveness are mainly determined by stent occlusion Previous studies have suggested that covered metallic stents may prevent tumor ingrowth and reduce the occlusion rate but tumor overgrowth is still problematic 11 12 13 Therefore there is a dire need for a metallic stent that prevents both tumor ingrowth and overgrowth
12 Paclitaxel Paclitaxel is a potent antineoplastic drug extracted from the bark of the pacific yew Taxus brevifolia and has been utilized for the therapy for ovarian breast lung and other cancers This potent drug exerts its pharmacological effects through a unique mechanism Paclitaxel causes formation of numerous decentralized and unorganized microtubules and enhances the assembly of extraordinarily stable and dysfunctional microtubules In addition it inhibits activation processes like activation of protein kinases or release of transcription factors In addition paclitaxel has several pharmacokinetic characteristics that make it well suited for locoregional cancer therapy It has rapid cellular uptake and a first pass effect because of its extremely lipophilic character and long lasting action over a broad concentration range Furthermore paclitaxel has antiangiogenic and antimetastatic properties The efficacy in dose dependent inhibition of cell proliferation of human gallbladder epithelial cells fibroblasts and pancreatic adenocarcinoma cells makes paclitaxel a very promising substance for local drug delivery to reduce the proliferative and migratory components that are involved in tumor growth This inhibitory effect of paclitaxel on the cell lines had served as the basis to develop drug-eluting stents for malignant biliary strictures
13 Paclitaxel-eluting covered metallic stent Covering the stent with chemotherapeutic agent such as paclitaxel should give protection against tumor ingrowth overgrowth or both resulting in increased patency longer survival rates and increased remaining quality of life There had been only few studies on the effect of a paclitaxel-eluting covered metallic stent on animal bile duct In a study on porcine bile duct the degree of histologic changes which included inflammatory cell infiltration and fibrous reactions corresponded to the amount of paclitaxel incorporated within the stent The degree of inflammatory change was more severe in porcine bile duct in contact with the stent with 20 concentration wtv of paclitaxel than the stent with 10 concentration There was no case of transmural necrosis and perforation The results of this particular study had served as a basis for further research In our preliminary study no significant complications such as perforation or stent migration have occurred in either DDS or CS group Therefore it can be suggested that this paclitaxel-eluting SEMS is safe in the normal canine bile duct
12 Paclitaxel Paclitaxel is a potent antineoplastic drug extracted from the bark of the pacific yew Taxus brevifolia and has been utilized for the therapy for ovarian breast lung and other cancers This potent drug exerts its pharmacological effects through a unique mechanism Paclitaxel causes formation of numerous decentralized and unorganized microtubules and enhances the assembly of extraordinarily stable and dysfunctional microtubules In addition it inhibits activation processes like activation of protein kinases or release of transcription factors In addition paclitaxel has several pharmacokinetic characteristics that make it well suited for locoregional cancer therapy It has rapid cellular uptake and a first pass effect because of its extremely lipophilic character and long lasting action over a broad concentration range Furthermore paclitaxel has antiangiogenic and antimetastatic properties The efficacy in dose dependent inhibition of cell proliferation of human gallbladder epithelial cells fibroblasts and pancreatic adenocarcinoma cells makes paclitaxel a very promising substance for local drug delivery to reduce the proliferative and migratory components that are involved in tumor growth This inhibitory effect of paclitaxel on the cell lines had served as the basis to develop drug-eluting stents for malignant biliary strictures
13 Paclitaxel-eluting covered metallic stent Covering the stent with chemotherapeutic agent such as paclitaxel should give protection against tumor ingrowth overgrowth or both resulting in increased patency longer survival rates and increased remaining quality of life There had been only few studies on the effect of a paclitaxel-eluting covered metallic stent on animal bile duct In a study on porcine bile duct the degree of histologic changes which included inflammatory cell infiltration and fibrous reactions corresponded to the amount of paclitaxel incorporated within the stent The degree of inflammatory change was more severe in porcine bile duct in contact with the stent with 20 concentration wtv of paclitaxel than the stent with 10 concentration There was no case of transmural necrosis and perforation The results of this particular study had served as a basis for further research In our preliminary study no significant complications such as perforation or stent migration have occurred in either DDS or CS group Therefore it can be suggested that this paclitaxel-eluting SEMS is safe in the normal canine bile duct
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None