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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Phase I/II Trial of Enteral Wallstents for Colonic Obstruction in the Setting of Malignancy

Conditions
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Colorectal Cancer, Constipation, Impaction, and Bowel Obstruction, Gastric Cancer, Gastrointestinal Carcinoid Tumor, Gastrointestinal Stromal Tumor, Quality of Life, Small Intestine Cancer

Intervention / Treatment
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* Procedure: bowel obstruction management
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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: 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, 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 Surgery: At least 3 weeks since prior surgery and recovered

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: bowel obstruction management|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent rectal cancer, localized gastrointestinal carcinoid tumor, regional gastrointestinal carcinoid tumor, small intestine adenocarcinoma, quality of life, stage I gastric cancer, stage II gastric cancer, stage III gastric cancer, stage IV gastric cancer, recurrent gastric cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, metastatic gastrointestinal carcinoid tumor, recurrent gastrointestinal carcinoid tumor, small intestine lymphoma, small intestine leiomyosarcoma, recurrent small intestine cancer, constipation, impaction, and bowel obstruction, gastrointestinal stromal tumor, stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer