A Quality of Life Comparison in Patients With Malignant Dysphagia Treated With Either Self-Expanding Plastic Stents (SEPS) or Self-Expanding Metal Stents (SEMS)
18 Years
N/A
Both
Esophageal Cancer, Gastrointestinal Complications
Trial Information
A Quality of Life Comparison in Patients With Malignant Dysphagia Treated With Either Self-Expanding Plastic Stents (SEPS) or Self-Expanding Metal Stents (SEMS)
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Supportive Care
Outcome Measure:
Change in health-related quality of life from baseline to 30 days and 3 months after self-expanding plastic stent or self-expanding metal stent placement
Principal Investigator
Sanjay Jagannath, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Sidney Kimmel Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000489157
NCT ID:
NCT00372450
Start Date:
June 2006
Completion Date:
Related Keywords:
- Esophageal Cancer
- Gastrointestinal Complications
- recurrent esophageal cancer
- stage III esophageal cancer
- stage IV esophageal cancer
- squamous cell carcinoma of the esophagus
- adenocarcinoma of the esophagus
- gastrointestinal complications
- Deglutition Disorders
- Esophageal Diseases
- Esophageal Neoplasms
Name | Location |
|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
