A Quality of Life Comparison in Patients With Malignant Dysphagia Treated With Either Self-Expanding Plastic Stents (SEPS) or Self-Expanding Metal Stents (SEMS)
- 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).
- 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
- 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
- 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.
Allocation: Randomized, Primary Purpose: Supportive Care
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
Sanjay Jagannath, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|