NCT00004911CompletedPhase 1
A Pilot Phase I/II Trial of Enteral Wallstents for Colonic Obstruction in the Setting of Malignancy
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Northwestern University
- Locations
- 2
Study Overview
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Supportive Care
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Platelet count greater than 50,000/mm^3
- •INR no greater than 1.5 times upper limit of normal
- •Not specified
- •Cardiovascular:
- •No cardiac condition
- •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
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Prior or concurrent chemotherapy allowed
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Prior or concurrent radiotherapy allowed
- •At least 3 weeks since prior surgery and recovered
Exclusion Criteria
- Not provided
Investigators
Study Sites (2)
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