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

Not Applicable

Withdrawn

• Conditions: Esophageal Cancer; Gastrointestinal Complications

• Registration Number: NCT00372450
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

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.

Study Timeline

• Study First Submitted: 2006-09-06
• Study First Submitted QC: 2006-09-06
• Study First Posted: 2006-09-07
• Study Start: 2006-12
• Primary Completion: 2008-04-11
• Study Completion: 2008-04-11
• Status Verified: 2008-11
• Last Update Submitted: 2019-03-18
• Last Update Posted: 2019-03-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Time to event (time until first complication)
Cost effectiveness of each type of stent
Overall rate of mortality
Degree and duration of improvement of dysphagia
Stent-related morbidities

Trial Locations

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States