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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Quality of Life Comparison in Patients With Malignant Dysphagia Treated With Either Self-Expanding Plastic Stents (SEPS) or Self-Expanding Metal Stents (SEMS)

Conditions
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Esophageal Cancer, Gastrointestinal Complications

Intervention / Treatment
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* Procedure: management of therapy complications
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed primary cancer of the esophagus or gastroesophageal junction Squamous cell or other type Diagnosis of malignant dysphagia Disease deemed surgically inoperable, but may be any of the following: Locally contained Locally advanced Metastatic Unresponsive to previous chemoradiotherapy Recurrent despite previous surgical resection Must be either an inpatient OR outpatient at Johns Hopkins Hospital No known tracheal compression by tumor burden PATIENT CHARACTERISTICS: Karnofsky performance status 50-100% Life expectancy ≥ 6 months Platelet count > 50,000/mm³ INR < 1.5 PRIOR CONCURRENT THERAPY: See Disease Characteristics Prior surgery, chemotherapy, biologic therapy, or radiotherapy allowed No concurrent surgery, chemotherapy, biologic therapy, or radiotherapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: management of therapy complications|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer, squamous cell carcinoma of the esophagus, adenocarcinoma of the esophagus, gastrointestinal complications