Colorectal Cancer Clinical Trial
Official title:
A Pilot Phase I/II Trial of Enteral Wallstents for Duodenal Obstruction in the Setting of Malignancy
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.
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.
;
Primary Purpose: Supportive Care
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