• Hai-Dong Zhu, Jin-He Guo, Ai-Wu Mao, Wei-Fu Lv, Jian-Song Ji, Wen-Hui Wang, Bin Lv, Rui-Min Yang, Wei Wu, Cai-Fang Ni, Jie Min, Guang-Yu Zhu, Li Chen, Mei-Ling Zhu, Zhen-Yu Dai, Peng-Fei Liu, Jian-Ping Gu, Wei-Xin Ren, Rui-Hua Shi, Gao-Feng Xu, Shi-Cheng He, Gang Deng, and Gao-Jun Teng.
• Department of Radiology, Zhong-da Hospital, Medical School, Southeast University, Nanjing, China.
• Lancet Oncol.. 2014 May 1;15(6):612-9.

BackgroundThe combination of stent insertion and single high-dose brachytherapy is a feasible and safe palliative treatment regimen in patients with unresectable oesophageal cancer. We aimed to further assess the efficacy of this treatment strategy compared to a conventional covered stent in patients with dysphagia caused by unresectable oesophageal cancer.MethodsIn this multicentre, single-blind, randomised, phase 3 trial, we enrolled patients with unresectable oesophageal cancer from 16 hospitals in China. We included adult patients (aged ≥ 20 years) with progressive dysphagia, unresectable tumours due to extensive lesions, metastases, or poor medical condition, and with clear consciousness, cooperation, and an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3. Eligible patients were randomly assigned (in 1:1 ratio, no stratification) to receive either a stent loaded with (125)iodine radioactive seeds (irradiation group) or a conventional oesophageal stent (control group). The primary endpoint was overall survival. Survival analyses were done in a modified intention-to-treat group. This study is registered with ClinicalTrials.gov, number NCT01054274.FindingsBetween Nov 1, 2009, and Oct 31, 2012, 160 patients were randomly assigned to receive treatment with either an irradiation stent (n=80) or a conventional stent (n=80). During a median follow-up of 138 days (IQR 72-207), 148 stents (73 in the irradiation group and 75 in the control group) were successfully placed into the diseased oesophagus in 148 participants. Median overall survival was 177 days (95% CI 153-201) in the irradiation group versus 147 days (124-170) in the control group (p=0.0046). Major complications and side-effects of the treatment were severe chest pain (17 [23%] of 73 patients in the irradiation group vs 15 [20%] of 75 patents in the control group), fistula formation (six [8%] vs five [7%]), aspiration pneumonia (11 [15%] vs 14 [19%]), haemorrhage (five [7%] vs five [7%]), and recurrent dysphagia (21 [28%] vs 20 [27%]).InterpretationIn patients with unresectable oesophageal cancer, the insertion of an oesophageal stent loaded with (125)iodine seeds prolonged survival when compared with the insertion of a conventional covered self-expandable metallic stent.Copyright © 2014 Elsevier Ltd. All rights reserved.

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