Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00422409
Status:
COMPLETED
Last Update Posted:
2011-07-06
First Post:
2007-01-16
Brief Title:
Endoscopic Stenting of Gastrointestinal Cancer
Sponsor:
Ullevaal University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Palliative Endoscopic Treatment of Malignant GI-strictures With Self Expanding Metal StentsSEMS-a Prospective Multicenter Study
Status:
COMPLETED
Status Verified Date:
2007-04
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:
Obstruction of the digestive tract is a frequent cause of morbidity in patients with gastrointestinal cancerPalliative endoscopic treatment with self- expanding metal stentsSEMSis an alternative to palliative surgery and other palliative treatment optionsThe method has expanded to include patients with malignancies in the esophagusgastroduodenal region biliary tractus and colon Numerous retrospective studies have reported treatment with SEMS to be safe and effective Prospective studiesand especially studies regarding Quality of Life improvement are needed
PURPOSE
The purpose of this trial is to prospectively study the use and effect of selfexpanding metal stentsSEMSin a defined population i Norway especially Quality of Life changes
PURPOSE
The purpose of this trial is to prospectively study the use and effect of selfexpanding metal stentsSEMSin a defined population i Norway especially Quality of Life changes
Detailed Description:
The study is divided into four projects
1 Establish a central register over all patients with malignant GI-obstruction who are treated with SEMS in the Eastern health region in Norway Treatment incidence methods used treatment effectcomplications related to the procedureNeed for reinterventions hospitalisations and survival will be studied
2 Quality of lifeQoL studies will be performed before and 14 days after treatmentThe EORTC QLQ C30 and EORTCs organospecific modules will be used
3 Gastric emptying beforeafter stent will be studied
4 Evaluate SEMS treatment of acute colon obstruction as a permanent palliative treatment or as a bridge to surgery
1 Establish a central register over all patients with malignant GI-obstruction who are treated with SEMS in the Eastern health region in Norway Treatment incidence methods used treatment effectcomplications related to the procedureNeed for reinterventions hospitalisations and survival will be studied
2 Quality of lifeQoL studies will be performed before and 14 days after treatmentThe EORTC QLQ C30 and EORTCs organospecific modules will be used
3 Gastric emptying beforeafter stent will be studied
4 Evaluate SEMS treatment of acute colon obstruction as a permanent palliative treatment or as a bridge to surgery
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