Clinical Trials Logo
  1. Home
  2. Esophageal Cancer
  3. NCT00372450

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

Esophageal Cancer Clinical Trial

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)

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00372450
Study type Interventional
Source Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Contact
Status Withdrawn
Phase N/A
Start date December 2006
Completion date April 11, 2008
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Terminated NCT01624090 - Mithramycin for Lung, Esophagus, and Other Chest Cancers Phase 2
Recruiting NCT05787522 - Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk
Not yet recruiting NCT05542680 - Study on the Design and Application of Special Semi Recumbent Cushion for Postoperative Patients With Esophageal Cancer N/A
Completed NCT03384511 - The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies. Phase 4
Completed NCT00003864 - Docetaxel Plus Carboplatin in Treating Patients With Advanced Cancer of the Esophagus Phase 2
Recruiting NCT05491616 - Nivolumab During Active Surveillance After Neoadjuvant Chemoradiation for Esophageal Cancer: SANO-3 Study Phase 2
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Completed NCT00199849 - NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine Phase 1
Completed NCT03756597 - PAN-study: Pan-Cancer Early Detection Study (PAN)
Completed NCT00400114 - Sutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer Phase 2
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Recruiting NCT04615806 - The Value of Lymph Node Dissection of Indocyanine Green-guided Near-infrared Fluorescent Imaging in Esophagectomy N/A
Active, not recruiting NCT04566367 - Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer N/A
Active, not recruiting NCT03962179 - Feasibility and Efficacy of a Combination of a SEMS and Vacuum Wound Treatment (VACStent) N/A
Terminated NCT01446874 - Prevention of Post-operative Pneumonia (POPP) Phase 2/Phase 3
Completed NCT03468634 - Raman Probe for In-vivo Diagnostics (During Oesophageal) Endoscopy N/A
Active, not recruiting NCT02869217 - Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors Phase 1
Completed NCT02810652 - Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection N/A
Recruiting NCT01404156 - Preoperative Chemotherapy vs. Chemoradiation in Esophageal / GEJ Adenocarcinoma Phase 2/Phase 3