Ignite Creation Date:
2024-05-05 @ 9:52 PM
Last Modification Date:
2024-10-26 @ 10:10 AM
Study NCT ID:
NCT00980889
Status:
COMPLETED
Last Update Posted:
2014-04-08
First Post:
2009-09-18
Brief Title:
RCT Steel Wallstent vs Nitinol Wallflex Bile Duct Stent for Palliation of Malignant Obstruction
Sponsor:
Stockholm South General Hospital
Organization:
Stockholm South General Hospital
Study Overview
Official Title:
RCT Steel Wallstent vs Nitinol Wallflex Bile Duct Stent for Palliation of Malignant Obstruction
Status:
COMPLETED
Status Verified Date:
2014-04
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:
Less than 20 of patients with malignant distal bile duct BD obstruction often pancreatic cancer are suitable for resection surgeryIn the restpalliation treatment comes into focus Jaundice caused by BD obstruction gives pain infection cholangitis often itching and increased weight loss and the patient is stigmatized by the deep yellow colour of the skinTherefore palliation with endoscopic stenting by ERCP-technique is important Modern self-expanding metal stents SEMS are now widely used in this context Comparison in a RCT between steel and nitinol SEMS has never been performed
The steel stent Wallstent is the originalis widely used and has more expanding power Nitinol stents are softer and claimed to be easier to insertand are more and more popularA newly developed nitinol stent Wallflexmay have these advantages but is some 120 Euros more expensive
Regarding the most important outcome measure time to stent failure obstruction no one knows if there is any differenceOur hypothesis is that there is no difference in this main outcome endpoint
The steel stent Wallstent is the originalis widely used and has more expanding power Nitinol stents are softer and claimed to be easier to insertand are more and more popularA newly developed nitinol stent Wallflexmay have these advantages but is some 120 Euros more expensive
Regarding the most important outcome measure time to stent failure obstruction no one knows if there is any differenceOur hypothesis is that there is no difference in this main outcome endpoint
Detailed Description:
Secondary outcome measures compare above are complications caused by the stent or stent insertion and technical ease to insert the stent To discover a 12 difference between the 2 groups regarding patency 400 patients must be included in the trial alfa 005 beta 08 Investigators know from previous trials Single center trial South Hospital GIE 200663986-995 and a newly finished similar swedish multicenter trialprel data DDW- 09that the 9 hospitals recruited will be able to include this no of patients in approximately 25 years
Investigators will have a shortest follow-up period of 10 months followup will be by phone with standard questions connected to stent failure which is defined clinically AND by a new ERCP with intervention because of an obstructed stent
Investigators will have a shortest follow-up period of 10 months followup will be by phone with standard questions connected to stent failure which is defined clinically AND by a new ERCP with intervention because of an obstructed stent
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