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Palliative brachytherapy with or without primary stent placement in patients with oesophageal cancer , a randomised phase III trial . PURPOSE 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 . CONCLUSION 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 .
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Intervention_Physical
Palliative brachytherapy
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Intervention_Surgical
with or without primary stent placement
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Intervention_Physical
combination of
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Intervention_Surgical
self-expanding metal stent ( SEMS )
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Intervention_Physical
and brachytherapy
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Outcome_Physical
dysphagia
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Outcome_Pain
pain
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Outcome_Physical
dysphagia
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Participant_Condition
oesophageal cancer
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Participant_Condition
oesophageal cancer
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Participant_Sample-size
41