Plastic Stents Compared With Metal Stents in Treating Patients With Malignant Dysphagia Caused by Esophageal Cancer or Gastroesophageal Junction Cancer
Recruitment status was: Active, not recruiting
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.
|Esophageal Cancer Gastrointestinal Complications||Procedure: management of therapy complications Procedure: quality-of-life assessment|
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||A Quality of Life Comparison in Patients With Malignant Dysphagia Treated With Either Self-Expanding Plastic Stents (SEPS) or Self-Expanding Metal Stents (SEMS)|
- 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
- Cost effectiveness of each type of stent
- Degree and duration of improvement of dysphagia
- Stent-related morbidities
- Time to event (time until first complication)
- Overall rate of mortality
|Study Start Date:||June 2006|
|Estimated Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372450
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Study Chair:||Sanjay Jagannath, MD||Sidney Kimmel Comprehensive Cancer Center|