Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004910
Status:
COMPLETED
Last Update Posted:
2012-06-06
First Post:
2000-03-07
Brief Title:
Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Pilot Phase III Trial of Enteral Wallstents for Duodenal Obstruction in the Setting of Malignancy
Status:
COMPLETED
Status Verified Date:
2012-05
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:
RATIONALE The use of endoscopy to place metal stents in the duodenum is less invasive than surgery for treating cancer-related duodenal obstruction and may have fewer side effects and improve recovery
PURPOSE Phase III trial to study the effectiveness of endoscopic placement of metal stents in treating patients who have cancer-related obstruction of the duodenum
PURPOSE Phase III trial to study the effectiveness of endoscopic placement of metal stents in treating patients who have cancer-related obstruction of the duodenum
Detailed Description:
OBJECTIVES
Determine the objective response and clinical outcome in patients with duodenal obstruction secondary to malignancy treated with enteral Wallstents
Evaluate the efficacy and safety of this treatment in these patients
Evaluate the quality of life of these patients after enteral Wallstent placement
OUTLINE Patients undergo enteral Wallstent placement through an endoscope under fluoroscopic guidance into the duodenum
Quality of life is assessed at 48 hours and 6 months after procedure
Patients are followed at 48 hours 30 days 6 months and then yearly thereafter until death
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Determine the objective response and clinical outcome in patients with duodenal obstruction secondary to malignancy treated with enteral Wallstents
Evaluate the efficacy and safety of this treatment in these patients
Evaluate the quality of life of these patients after enteral Wallstent placement
OUTLINE Patients undergo enteral Wallstent placement through an endoscope under fluoroscopic guidance into the duodenum
Quality of life is assessed at 48 hours and 6 months after procedure
Patients are followed at 48 hours 30 days 6 months and then yearly thereafter until death
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G00-1703 | None | None | None |
| NU-98CC2 | None | None | None |