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

Johns Hopkins Medicine

Status: Withdrawn

Conditions: Esophageal Cancer; Gastrointestinal Complications

Treatments: Procedure: management of therapy complications; Procedure: quality-of-life assessment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00372450

JHOC-J05109

J05109

CDR0000489157 (Registry Identifier)

NA_00001547 (Other Identifier)

Details and patient eligibility

About

RATIONALE: Placing a stent in the esophagus may lessen swallowing difficulties and improve quality of life in patients with malignant dysphagia caused by esophageal cancer or gastroesophageal junction cancer.

PURPOSE: This randomized clinical trial is studying self-expanding plastic stents to see how well they work compared with self-expanding metal stents in treating patients with malignant dysphagia caused by esophageal cancer or gastroesophageal junction cancer.

Full description

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.

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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