title: Palliative brachytherapy with or without primary stent placement in patients with oesophageal cancer, a randomised phase III trial.
abstract: OBJECTIVE
  To investigate whether a combination of self-expanding metal stent (SEMS) and brachytherapy provided more rapid and prolonged effect on dysphagia without increased pain compared to brachytherapy alone in patients with incurable oesophageal cancer.
  
  
  METHODS
  41 Patients were randomised to SEMS followed by brachytherapy, 8 Gy×3 (n=21) or brachytherapy alone, 8 Gy×3 (n=20). Change in dysphagia and pain three and seven weeks after randomisation (FU1 and FU2) was assessed by patient-reported outcome. Dysphagia, other symptoms and health-related quality of life were assessed every four weeks thereafter. The study was closed before the estimated patient-number was reached due to slow recruitment.
  
  
  RESULTS
  Patients receiving SEMS followed by brachytherapy had significantly improved dysphagia at FU1 compared to patients receiving brachytherapy alone (n=35). Difference in pain was not observed. At FU2, patients in both arms (n=21) had less dysphagia. Four patients in the combined treatment arm experienced manageable complications, no complications occurred after brachytherapy alone.
  
  
  CONCLUSIONS
  For the relief of dysphagia, SEMS followed by brachytherapy is preferable and safe for patients in need of immediate alleviation, while brachytherapy with or without preceding SEMS provides relief within a few weeks after treatment.
authors: Department of Oncology, Oslo University Hospital, Norway. cecia@ous-hf.no
authors: Cecilie Delphin
authors: CD
authors: Amdal
authors: Anne-Birgitte
authors: AB
authors: Jacobsen
authors: Berit
authors: B
authors: Sandstad
authors: Trond
authors: T
authors: Warloe
authors: Kristin
authors: K
authors: Bjordal
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001918:Brachytherapy / Q000009:adverse effects; D003680:Deglutition Disorders / Q000209:etiology; D004938:Esophageal Neoplasms / Q000401:mortality / Q000523:psychology / Q000532:radiotherapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010166:Palliative Care; D011788:Quality of Life; D015607:Stents
keywords: Brachytherapy; Dysphagia; Oesophageal neoplasm; Quality of life; Randomised trial; Stent