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Home > "E" Clinical Trials Conditions > Endoscopic Placement of Metal Stent in Patients With Cancer-Related Bowel Obstruction

Endoscopic Placement of Metal Stent in Patients With Cancer-Related Bowel Obstruction



Endoscopic Placement of Metal Stent in Patients With Cancer-Related Bowel Obstruction

For Condition: Gastric Cancer,Colorectal Cancer,Rectal Cancer,Colon Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Robert H. Lurie Cancer Center
Synopsis: 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.
Details: OBJECTIVES: I. Determine the objective response and clinical outcome in patients with colonic obstruction secondary to malignancy treated with enteral Wallstents. II. Evaluate the efficacy and safety of this treatment in these patients. III. Evaluate the quality of life of these patients after enteral Wallstent placement. PROTOCOL 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.
Eligibility:
Study Type:
  Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Endoscopically confirmed localized tumor as the cause of colonic obstruction - All primary tumor types are eligible No prior colonic Wallstents Must have symptoms of gastrointestinal obstruction, including: - Inability to move bowels, absence of flatus, nausea/vomiting, abdominal pain, or diarrhea --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: Prior or concurrent chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: Prior or concurrent radiotherapy allowed Surgery: At least 3 weeks since prior surgery and recovered --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-3 Life expectancy: Not specified Hematopoietic: Platelet count greater than 50,000/mm3 Hepatic: INR no greater than 1.5 times upper limit of normal Renal: Not specified Cardiovascular: No cardiac condition Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No significant active infection (e.g., pneumonia, peritonitis, wound abscess) that would preclude endoscopy - No other serious concurrent illness - No uncontrolled metabolic disease (e.g., diabetes or hypothyroidism) - No dementia, psychiatric disorder, or altered mental status that would preclude compliance - History of other neoplastic disease allowed - Veterans Administration patients are not eligible
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
WillisParsons,  Study Chair,  Robert H. Lurie Cancer Center

Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago,  Illinois,  60611-3013
United States
 


Additional Information:
Study ID Numbers:
  CDR0000067591;  NU-98CC3,NCI-G00-1704
Study Start Date: January 2000
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004911

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