Plastic Stents Compared With Metal Stents in Treating Patients With Malignant Dysphagia Caused by Esophageal Cancer or Gastroesophageal Junction Cancer
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|ClinicalTrials.gov Identifier: NCT00372450|
Recruitment Status : Unknown
Verified November 2008 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : September 7, 2006
Last Update Posted : May 12, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer Gastrointestinal Complications||Procedure: management of therapy complications Procedure: quality-of-life assessment||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|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)|
|Study Start Date :||June 2006|
|Estimated Primary Completion Date :||June 2008|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 at Johns Hopkins|