NCT00372450

Plastic Stents Compared With Metal Stents in Treating Patients With Malignant Dysphagia Caused by Esophageal Cancer or Gastroesophageal Junction Cancer

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• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Esophageal Cancer
• Gastrointestinal Complications

Interventions

Type	Name	Description
PROCEDURE	management of therapy complications
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2006-12-01
• Primary completion: 2008-04-11
• Completion: 2008-04-11
• First posted: 2006-09-07
• Last updated: 2019-03-20

Locations

1 site across 1 country: United States