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

Northwestern University

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

SUPPORTIVE_CARE

Conditions

Colorectal Cancer Constipation, Impaction, and Bowel Obstruction Gastric Cancer Gastrointestinal Carcinoid Tumor Gastrointestinal Stromal Tumor 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 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

Locations (1)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, United States

Data from ClinicalTrials.gov

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