Status:
COMPLETED
Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Constipation, Impaction, and Bowel Obstruction
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 recover...
Detailed Description
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 o...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Endoscopically confirmed localized tumor as the cause of duodenal obstruction
- All primary tumor types are eligible
- No prior duodenal Wallstents
- Must have symptoms of gastrointestinal obstruction, including:
- Inability to move bowels, absence of flatus, nausea/vomiting, abdominal pain, or diarrhea
- PATIENT CHARACTERISTICS:
- Age:
- 18 and over
- Performance status:
- ECOG 0-3
- Life expectancy:
- Not specified
- Hematopoietic:
- Platelet count greater than 50,000/mm\^3
- 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, or wound abscess) that would preclude endoscopy
- No other serious concurrent illness
- No uncontrolled metabolic disease (e.g., diabetes mellitus 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
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
End Date :
February 1 2003
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00004910
Start Date
January 1 2000
End Date
February 1 2003
Last Update
June 6 2012
Active Locations (1)
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1
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013