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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
Relief of dysphagia measured by dysphagia scores, survival time from the interventional procedure to the last follow-up.
Follow-up in intervals of 1, 3, 6 and 12 months after stent placement
Gao-Jun Teng, MD. Ph.D
Principal Investigator
Zhongda Hospital, Southeast University
China: Food and Drug Administration
320106196208052017
NCT00477841
April 2004
December 2006
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