Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00372450
Status:
WITHDRAWN
Last Update Posted:
2019-03-20
First Post:
2006-09-06
Brief Title:
Plastic Stents Compared With Metal Stents in Treating Patients With Malignant Dysphagia Caused by Esophageal Cancer or Gastroesophageal Junction Cancer
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2008-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed 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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NA_00001547 | OTHER | JHM IRB | None |
| CDR0000489157 | REGISTRY | None | None |
| JHOC-J05109 | None | None | None |