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

Northwestern University

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

SUPPORTIVE_CARE

Conditions

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

Interventions

bowel obstruction managementPROCEDURE

quality-of-life assessmentPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, United States

Data from ClinicalTrials.gov

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