title: Conventional stents versus stents loaded with (125)iodine seeds for the treatment of unresectable oesophageal cancer: a multicentre, randomised phase 3 trial.
abstract: BACKGROUND
  The 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.
  
  
  METHODS
  In 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.
  
  
  RESULTS
  Between 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%]).
  
  
  CONCLUSIONS
  In 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.
authors.affiliation: Department of Radiology, Zhong-da Hospital, Medical School, Southeast University, Nanjing, China.
authors.forename: Hai-Dong
authors.initials: HD
authors.lastname: Zhu
authors.affiliation: Department of Radiology, Zhong-da Hospital, Medical School, Southeast University, Nanjing, China.
authors.forename: Jin-He
authors.initials: JH
authors.lastname: Guo
authors.affiliation: Department of Interventional Radiology, Shanghai St Luke's Hospital, Shanghai, China.
authors.forename: Ai-Wu
authors.initials: AW
authors.lastname: Mao
authors.affiliation: Department of Interventional Radiology, Imaging Center, Anhui Provincial Hospital, Hefei, China.
authors.forename: Wei-Fu
authors.initials: WF
authors.lastname: Lv
authors.affiliation: Department of Radiology, Lishui Central Hospital, Wenzhou Medical College, Lishui, China.
authors.forename: Jian-Song
authors.initials: JS
authors.lastname: Ji
authors.affiliation: Department of Interventional Radiology, The First Hospital, Lanzhou University, Lanzhou, China.
authors.forename: Wen-Hui
authors.initials: WH
authors.lastname: Wang
authors.affiliation: Department of Gastroenterology, The Affiliated Hospital of Zhejiang Traditional Chinese Medicine College, Hangzhou, China.
authors.forename: Bin
authors.initials: B
authors.lastname: Lv
authors.affiliation: Department of Interventional Radiology, First Affiliated Hospital of Xinxiang Medical College, Weihui, China.
authors.forename: Rui-Min
authors.initials: RM
authors.lastname: Yang
authors.affiliation: Department of Gastroenterology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Wu
authors.affiliation: Department of Interventional Radiology, First Affiliated Hospital of Soochow University, Suzhou, China.
authors.forename: Cai-Fang
authors.initials: CF
authors.lastname: Ni
authors.affiliation: Department of Epidemiology and Biostatistics, School of Public Health, Southeast University, Nanjing, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Min
authors.affiliation: Department of Radiology, Zhong-da Hospital, Medical School, Southeast University, Nanjing, China.
authors.forename: Guang-Yu
authors.initials: GY
authors.lastname: Zhu
authors.affiliation: Department of Radiology, Zhong-da Hospital, Medical School, Southeast University, Nanjing, China.
authors.forename: Li
authors.initials: L
authors.lastname: Chen
authors.affiliation: Department of Gastroenterology, Suqian People's Hospital, Drum Tower Hospital Group, Nanjing, Suqian, China.
authors.forename: Mei-Ling
authors.initials: ML
authors.lastname: Zhu
authors.affiliation: Department of Radiology, The Affiliated Yancheng hospital of Southeast University Medical College, Yancheng, China.
authors.forename: Zhen-Yu
authors.initials: ZY
authors.lastname: Dai
authors.affiliation: Department of Gastroenterology, The Affiliated Jiangyin People's Hospital of Southeast University Medical College, Jiangyin, China.
authors.forename: Peng-Fei
authors.initials: PF
authors.lastname: Liu
authors.affiliation: Department of Interventional Radiology, Nanjing First Hospital Affiliated to Nanjing Medical University, Nanjing, China.
authors.forename: Jian-Ping
authors.initials: JP
authors.lastname: Gu
authors.affiliation: Department of Interventional Radiology, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.
authors.forename: Wei-Xin
authors.initials: WX
authors.lastname: Ren
authors.affiliation: Department of Gastroenterology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
authors.forename: Rui-Hua
authors.initials: RH
authors.lastname: Shi
authors.affiliation: Department of Radiology, The First People's Hospital of Yancheng, Yancheng 224001, China.
authors.forename: Gao-Feng
authors.initials: GF
authors.lastname: Xu
authors.affiliation: Department of Radiology, Zhong-da Hospital, Medical School, Southeast University, Nanjing, China.
authors.forename: Shi-Cheng
authors.initials: SC
authors.lastname: He
authors.affiliation: Department of Radiology, Zhong-da Hospital, Medical School, Southeast University, Nanjing, China.
authors.forename: Gang
authors.initials: G
authors.lastname: Deng
authors.affiliation: Department of Radiology, Zhong-da Hospital, Medical School, Southeast University, Nanjing, China. Electronic address: gjteng@vip.sina.com.
authors.forename: Gao-Jun
authors.initials: GJ
authors.lastname: Teng
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000532:radiotherapy*; D000368:Aged; D001918:Brachytherapy / Q000295:instrumentation / Q000379:methods*; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000532:radiotherapy*; D004938:Esophageal Neoplasms / Q000401:mortality / Q000532:radiotherapy*; D005260:Female; D006801:Humans; D007457:Iodine Radioisotopes / Q000627:therapeutic use; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D016037:Single-Blind Method; D015607:Stents
chemical_list: D007457:Iodine Radioisotopes