Clinical Trial: Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Pilot Phase I/II Trial of Enteral Wallstents for Duodenal Obstruction in the Setting of Malignancy
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 I/II trial to study the effectiveness of endoscopic placement of metal stents in treating patients who have cancer-related obstruction of the duodenum.
Detailed Summary:
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.
Sponsor: Northwestern University
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Northwestern University
Dates:
Date Received: March 7, 2000
Date Started: January 2000
Date Completion:
Last Updated: May 31, 2012
Last Verified: May 2012
