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

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

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Patrocinadores

Patrocinador principal: Northwestern University

Colaborador: National Cancer Institute (NCI)

Fuente Northwestern University
Resumen breve

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.

Descripción detallada

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.

Estado general Completed
Fecha de inicio January 2000
Fecha de Terminación February 2003
Fecha de finalización primaria February 2003
Fase Phase 1/Phase 2
Tipo de estudio Interventional
Condición
  • Colorectal Cancer
  • Constipation, Impaction, and Bowel Obstruction
  • Gastric Cancer
  • Gastrointestinal Carcinoid Tumor
  • Gastrointestinal Stromal Tumor
  • Quality of Life
  • Small Intestine Cancer
Intervención

Tipo de intervención: Procedure

Nombre de intervención: bowel obstruction management

Tipo de intervención: Procedure

Nombre de intervención: quality-of-life assessment

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Willis G. Parsons, MD, PC Study Chair Robert H. Lurie Cancer Center
Ubicación
Instalaciones: Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Ubicacion Paises

United States

Fecha de verificación

May 2012

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Información de diseño del estudio

Propósito primario: Supportive Care

Source: ClinicalTrials.gov