Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction

Study Overview
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Brief Summary
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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.

Detailed Description
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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 of this treatment in these patients. 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.

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

Conditions
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Colorectal Cancer, Constipation, Impaction, and Bowel Obstruction, Extrahepatic Bile Duct Cancer, Gastric Cancer, Gastrointestinal Carcinoid Tumor, Gastrointestinal Stromal Tumor, Pancreatic Cancer, 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 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

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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stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer, stage I gastric cancer, stage II gastric cancer, stage III gastric cancer, stage IV gastric cancer, recurrent gastric cancer, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer, recurrent colon cancer, localized gastrointestinal carcinoid tumor, regional gastrointestinal carcinoid tumor, metastatic gastrointestinal carcinoid tumor, recurrent gastrointestinal carcinoid tumor, small intestine adenocarcinoma, recurrent extrahepatic bile duct cancer, recurrent small intestine cancer, constipation, impaction, and bowel obstruction, quality of life, gastrointestinal stromal tumor, stage IV pancreatic cancer, small intestine lymphoma, small intestine leiomyosarcoma, localized extrahepatic bile duct cancer, unresectable extrahepatic bile duct cancer