Left thoracoabdominal approach versus abdominal-transhiatal approach for gastric cancer of the cardia or subcardia: a randomised controlled trial
Left thoracoabdominal approach versus abdominal-transhiatal approach for gastric cancer of the cardia or subcardia: a randomised controlled trial
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DOI：
10.1016/s1470-2045(06)70766-5
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发表时间：
2006-08-01
期刊：
影响因子：
51.1
通讯作者：
Hiratsuka, Masahiro
中科院分区：
文献类型：
--
作者：
Sasako, Mitsuru;Sano, Takeshi;Hiratsuka, Masahiro
背景由于纵隔淋巴结转移瘤难以进入，左胸腹联合入路（LTA）常用于治疗贲门或贲门下区胃癌。方法从1995年7月至2003年12月，从日本27家医院招募了167例患者，随机分为经腹裂孔入路（TH）组（82例）和经腹裂孔入路（LTA）组（85例）。主要终点为总生存期，次要终点为无病生存期、术后发病率和住院死亡率、术后症状和呼吸功能变化。预计样本量为302。在第一次中期分析后，最终分析时LTA的总生存期显著优于TH的预测概率仅为3.65%，试验立即关闭。该研究在ClinicalTrials.gov注册，编号NCT 00149266。结果5年总生存率为52.3%（95%CI 40.4-64. 1)TH组为37.9%（26.1-49.6）;与TH相比，LTA的死亡风险比为1.36（0.89-2.08，p=0.92）。3例患者在LTA后死于医院，但无一例在TH后死亡。解释因为LTA不能改善TH后的生存率，并导致贲门癌患者的发病率增加。或贲门下，LTA不能合理治疗这些肿瘤。
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 ClinicalTrials.gov, 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 cannot be justified to treat these tumours.