Trial Information

Phase IV Study of Self-Expandable Esophageal Stent Loaded With 125I Seeds: a Randomized Controlled Multiple Center Trial in Patients With Advanced Esophageal Cancer

Esophageal cancer ranks 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 following preliminary clinical study in a single
institute has demonstrated longer survival time, better quality of life and less restenosis
of the stent than whose with the conventional stent. This prospective multiple center trial
is designed to further demonstrate the clinical outcomes with this irradiation, stent in
patients compared to those using a conventional covered stent.