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Brief Title: Endoscopic Placement of Metal Stent in Patients With Cancer-Related Bowel Obstruction
Official Title: A Pilot Phase I/II Trial of Enteral Wallstents for Colonic Obstruction in the Setting of Malignancy
Study ID: NCT00004911
Brief Summary: 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.
Detailed Description: OBJECTIVES: * 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States
Name: Willis G. Parsons, MD, PC
Affiliation: Robert H. Lurie Cancer Center
Role: STUDY_CHAIR