Endoscopic Placement of Metal Stent in Patients With Cancer-Related Bowel Obstruction
RATIONALE: The use of endoscopy to place a metal stent in the large intestine is less invasive than surgery for treating cancer-related bowel obstruction and may have fewer side effects and improve recovery.
PURPOSE: Phase I/II trial to study the effectiveness of endoscopic placement of a metal stent in treating patients who have cancer-related bowel obstruction.
|Colorectal Cancer Constipation, Impaction, and Bowel Obstruction Gastric Cancer Gastrointestinal Carcinoid Tumor Gastrointestinal Stromal Tumor Quality of Life Small Intestine Cancer||Procedure: bowel obstruction management Procedure: quality-of-life assessment||Phase 1 Phase 2|
|Study Design:||Primary Purpose: Supportive Care|
|Official Title:||A Pilot Phase I/II Trial of Enteral Wallstents for Colonic Obstruction in the Setting of Malignancy|
|Study Start Date:||January 2000|
|Study Completion Date:||February 2003|
|Primary Completion Date:||February 2003 (Final data collection date for primary outcome measure)|
- Determine the objective response and clinical outcome in patients with colonic 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: All patient undergo a colonoscopy, followed by placement of an enteral Wallstent through an endoscope under fluoroscopic guidance into the large intestine.
Quality of life is assessed at 48 hours and 6 months after the 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004911
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|Study Chair:||Willis G. Parsons, MD, PC||Robert H. Lurie Cancer Center|