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

Date de début de l'étude : 1 janvier 2000

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