Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00477841
Status:
COMPLETED
Last Update Posted:
2008-04-18
First Post:
2007-05-22
Brief Title:
Self-Expandable Esophageal Radiation Stenta Randomized Controlled Trial in Patients With Advanced Esophageal Cancer
Sponsor:
Southeast University China
Organization:
Southeast University China
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine the response to treatment with a novel esophageal stent loaded with 125I seeds for intraluminal brachytherapy versus a conventional covered stent in patients with advanced esophageal cancer
Detailed Description:
Esophageal cancer is common in some areas ranking as the fourth leading cause of death from cancer in China and sixth worldwide Although the prognosis of surgical resection for esophageal cancer has been improved more than 50 of such patients are inoperable and have to undergo palliative treatments because of late stage cancer or metastasis Dysphagia is the predominate symptom of patients with inoperable esophageal cancer To relieve the dysphagia and improve the quality of life of such patients brachytherapy has previously been utilized Recently stent placement has been widely accepted to be an option for palliation of the symptoms due to the esophageal strictures However recurrence of the neoplastic stricture remains a challenge after stent placement To combine the advantages of the immediate relief of the esophageal dysphagia with the stent placement and radiation therapy with brachytherapy a novel esophageal stent loaded with 125I seeds has been developed in the authors institute The technical feasibility and safety with this new stent has been demonstrated to be adequate in a healthy rabbit model The current study is designed to demonstrate the preliminary results with this irradiation stent in patients with inoperable esophageal cancer compared to those using a conventional covered stent
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