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document
Left thoracoabdominal approach versus abdominal-transhiatal approach for gastric cancer of the cardia or subcardia : a randomised controlled trial . BACKGROUND Because of the inaccessibility of mediastinal nodal metastases , the left thoracoabdominal approach ( LTA ) has often been used to treat gastric cancer of the cardia or subcardia . In a randomised phase III study , we aimed to compare LTA with the abdominal-transhiatal approach ( TH ) in the treatment of these tumours . METHODS Between July , 1995 , and December , 2003 , 167 patients were enrolled from 27 Japanese hospitals and randomly assigned to TH ( n=82 ) or LTA ( n=85 ) . The primary endpoint was overall survival , and secondary endpoints were disease-free survival , postoperative morbidity and hospital mortality , and postoperative symptoms and change of respiratory function . The projected sample size was 302 . After the first interim analysis , the predicted probability of LTA having a significantly better overall survival than TH at the final analysis was only 3.65 % , and the trial was closed immediately . Analysis was by intention to treat . This study is registered with , number NCT00149266 . FINDINGS 5-year overall survival was 52.3 % ( 95 % CI 40.4-64.1 ) in the TH group and 37.9 % ( 26.1-49.6 ) in the LTA group . The hazard ratio of death for LTA compared with TH was 1.36 ( 0.89-2.08 , p=0.92 ) . Three patients died in hospital after LTA but none after TH . Morbidity was worse after LTA than after TH . INTERPRETATION Because LTA does not improve survival after TH and leads to increased morbidity in patients with cancer of the cardia or subcardia , LTA can not be justified to treat these tumours .
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Intervention_Surgical
Left thoracoabdominal approach
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Intervention_Surgical
abdominal-transhiatal approach
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Intervention_Surgical
left thoracoabdominal approach ( LTA )
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Intervention_Surgical
LTA with the abdominal-transhiatal approach ( TH ) in the treatment
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Outcome_Other
compare
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Outcome_Mortality
overall survival
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Outcome_Physical
disease-free survival
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Outcome_Physical
postoperative morbidity
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Outcome_Mortality
hospital mortality
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Outcome_Physical
postoperative symptoms
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Outcome_Physical
change of respiratory function
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Outcome_Mortality
5-year overall survival
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Outcome_Mortality
hazard ratio of death
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Outcome_Physical
for LTA
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Outcome_Mortality
died
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Outcome_Physical
Morbidity
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Participant_Condition
The projected sample size was 302 . After the first interim analysis , the predicted probability of LTA having a significantly better overall survival than TH at the final analysis was only 3.65 % , and the trial was closed immediately .
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Participant_Condition
patients with cancer of the cardia or subcardia