Self-Expandable Esophageal Radiation Stent:a Randomized Controlled Trial in Patients With Advanced Esophageal Cancer
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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.
Condition or disease
Procedure: Esophageal stent placementProcedure: dysphagia scoresProcedure: complications of therapyProcedure: survival time of therapy
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.
Relief of dysphagia measured by dysphagia scores, survival time from the interventional procedure to the last follow-up. [ Time Frame: Follow-up in intervals of 1, 3, 6 and 12 months after stent placement ]
Secondary Outcome Measures
Successful rate of stent placement, Stent-related complications and morbidity, Overall rate of mortality [ Time Frame: Follow-up in intervals of 1, 3, 6, and 12 months after stent placement ]
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Ages Eligible for Study:
20 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Histologically confirmed primary cancer of esophagus,
Must be dysphagia caused by esophageal cancer,
Surgically inoperable, but may be metastatic,
Without esophageal fistulas,
Must be an inpatient at Zhongda Hospital,
Life expectancy is over 6 months,
Tracheal compression with symptoms,
WBC <2000/mm3 and Platelet count <50,000/mm3,
Concurrent therapies:surgery, chemotherapy,radiotherapy, Traditional Chinese Medicine