Plastic Stents Compared With Metal Stents in Treating Patients With Malignant Dysphagia Caused by Esophageal Cancer or Gastroesophageal Junction Cancer

OBJECTIVES:

Primary

- Assess differences from baseline in health-related quality of life of patients with
malignant dysphagia due to cancer of the esophagus or gastroesophageal junction
palliated with self-expanding plastic stents (SEPS) compared to those who receive
self-expanding metal stents (SEMS).

Secondary

- Perform a cost-effective analysis of each type of stent by independent evaluation of the
rates of SEPS-related and SEMS-related morbidity that necessitates repeat endoscopic
interventions and/or additional healthcare costs in these patients.

- Analyze effective palliation (degree and duration of improvement of dysphagia) in these
patients.

- Determine the individual rates of complication associated with each type of esophageal
stent in these patients.

OUTLINE: This is a randomized, controlled study. Patients are randomized to 1 of 2 treatment
arms.

- Arm I: Patients undergo placement of a self-expanding metal stent on day 1.

- Arm II: Patients undergo placement of a self-expanding plastic stent on day 1.
Health-related quality of life is assessed at baseline, 30 days, and 3 months.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

- Histologically confirmed primary cancer of the esophagus or gastroesophageal junction

- Squamous cell or other type

- Diagnosis of malignant dysphagia

- Disease deemed surgically inoperable, but may be any of the following:

- Locally contained

- Locally advanced

- Metastatic

- Unresponsive to previous chemoradiotherapy

- Recurrent despite previous surgical resection

- Must be either an inpatient OR outpatient at Johns Hopkins Hospital

- No known tracheal compression by tumor burden

PATIENT CHARACTERISTICS:

- Karnofsky performance status 50-100%

- Life expectancy ≥ 6 months

- Platelet count > 50,000/mm³

- INR < 1.5

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Prior surgery, chemotherapy, biologic therapy, or radiotherapy allowed

- No concurrent surgery, chemotherapy, biologic therapy, or radiotherapy