Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction
Study Details
Study Description
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 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
OBJECTIVES:
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Determine the objective response and clinical outcome in patients with duodenal obstruction secondary to malignancy treated with enteral Wallstents.
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Evaluate the efficacy and safety of this treatment in these patients.
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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.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Endoscopically confirmed localized tumor as the cause of duodenal obstruction
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All primary tumor types are eligible
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No prior duodenal Wallstents
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Must have symptoms of gastrointestinal obstruction, including:
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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:
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Not pregnant or nursing
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Fertile patients must use effective contraception
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No significant active infection (e.g., pneumonia, peritonitis, or wound abscess) that would preclude endoscopy
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No other serious concurrent illness
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No uncontrolled metabolic disease (e.g., diabetes mellitus or hypothyroidism)
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No dementia, psychiatric disorder, or altered mental status that would preclude compliance
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History of other neoplastic disease allowed
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago | Illinois | United States | 60611-3013 |
Sponsors and Collaborators
- Northwestern University
- National Cancer Institute (NCI)
Investigators
- Study Chair: Willis G. Parsons, MD, PC, Robert H. Lurie Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NU 98CC2
- NU-98CC2
- NCI-G00-1703