a Multicentric Randomized Controlled Trial of Self-Expandable Esophageal Radiation Stent

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. Brachytherapy and esophageal self-expanding stent insertion have longer benefit. Stent insertion provides fastest improvement of dysphagia.However, recurrence of the neoplastic stricture remains a challenge after stent placement, complications in later setting occur and require further endoscopic treatment. Brachytherapy has slower onset of benefit but has fewer complications and longer benefit.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. And a small-sample and unicentric prior clinical trial in the authors' institute certificated the novel esophageal stent can relieve the dysphagia caused by advanced esophageal cancer rapidly and improve the quality of life markedly. This current multicentric randomized clinical trial is further studying the novel esophageal stent loaded with 125I seeds to see how well they work compared with a conventional covered stent in patients with malignant dysphagia caused by advanced esophageal cancer.

Sex

All

Minimum age

20 Years

Maximum age

80 Years

Inclusion Criteria:

* Endoscopically and histologically confirmed cancer of esophagus
* Progressive dysphagia caused by esophageal cancer, and the dysphagia grade of level Ⅲ or level Ⅳ\[STOOLER stand\]
* In barium meal of esophagus, severe stricture of the cancer make the barium difficult to pass through and the superior normal esophagus broaden
* The bulk and shape of the oesophageal cancer displayed by CT three-dimensional reconstruction
* Patients with clear consciousness，Cooperation，ECOG performance status of 0,1 and 3
* Informed consent: authorization and signature

Exclusion Criteria:

* Poor general status,ECOG performance status of 4,
* Dysphagia not caused by esophageal cancer,
* Noncooperation or no authorization and signature.
* The superior border of cancer higher than the seventh cervical vertebrae
* Ulcerative esophageal carcinoma
* Esophageal fistulas,
* WBC less than 3000/mm3

  * Severe hepatic inadequacy or renal inadequacy,

• RESULTGuo JH, Teng GJ, Zhu GY, He SC, Deng G, He J. Self-expandable stent loaded with 125I seeds: feasibility and safety in a rabbit model. Eur J Radiol. 2007 Feb;61(2):356-61. doi: 10.1016/j.ejrad.2006.10.003. Epub 2006 Nov 7. PMID 17085003
• RESULTGuo JH, Teng GJ, Zhu GY, He SC, Fang W, Deng G, Li GZ. Self-expandable esophageal stent loaded with 125I seeds: initial experience in patients with advanced esophageal cancer. Radiology. 2008 May;247(2):574-81. doi: 10.1148/radiol.2472070999. Epub 2008 Mar 18. PMID 18349316
• DERIVEDZhu HD, Guo JH, Mao AW, Lv WF, Ji JS, Wang WH, Lv B, Yang RM, Wu W, Ni CF, Min J, Zhu GY, Chen L, Zhu ML, Dai ZY, Liu PF, Gu JP, Ren WX, Shi RH, Xu GF, He SC, Deng G, Teng GJ. Conventional stents versus stents loaded with (125)iodine seeds for the treatment of unresectable oesophageal cancer: a multicentre, randomised phase 3 trial. Lancet Oncol. 2014 May;15(6):612-9. doi: 10.1016/S1470-2045(14)70131-7. Epub 2014 Apr 14. PMID 24742740