Department of General Thoracic Surgery, Juntendo University School of Medicine, Tokyo, Japan.
Department of General Thoracic Surgery, St Marianna University School of Medicine, Kanagawa, Japan.
J Thorac Cardiovasc Surg. 2019 Sep;158(3):895-907. doi: 10.1016/j.jtcvs.2019.03.090. Epub 2019 Apr 9.
No definitive comparisons of surgical morbidity between segmentectomy and lobectomy for non-small cell lung cancer have been reported.
We conducted a randomized controlled trial to confirm the noninferiority of segmentectomy to lobectomy in regard to prognosis (trial No. JCOG0802/WJOG4607L). Patients with invasive peripheral non-small cell lung cancer tumor of a diameter ≤2 cm were randomized to undergo either lobectomy or segmentectomy. The primary end point was overall survival. Here, we have focused on morbidity and mortality. Predictors of surgical morbidity were evaluated by the mode of surgery. Segmentectomy was categorized into simple and complex. Simple segmentectomy was defined as segmental resection of the right or left segment 6, left superior, or lingular segment. Complex segmentectomy was resection of the other segment. This trial is registered with the University Hospital Medical Information Network--Clinical Trial Registry (UMIN000002317).
Between August 10, 2009, and October 21, 2014, 1106 patients (lobectomy n = 554 and segmentectomy n = 552) were enrolled. No mortality was noted. Complications (grade ≥ 2) occurred in 26.2% and 27.4% in the lobectomy and segmentectomy arms (P = .68), respectively. Fistula/pulmonary-lung (air leak) was detected in 21 (3.8%) and 36 (6.5%) patients in the lobectomy and segmentectomy arms (P = .04), respectively. Multivariable analysis revealed that predictors of pulmonary complications, including air leak and empyema (grade ≥ 2) were complex segmentectomy (vs lobectomy) (odds ratio, 2.07; 95% confidence interval, 1.11-3.88; P = .023), and > 20 pack-years of smoking (odds ratio, 2.61; 95% confidence interval, 1.14-5.97; P = .023).
There was no difference in almost any postoperative measure of intraoperative and postoperative complication in segmentectomy and lobectomy patients, except more air leakage was observed in the segmentectomy arm. Segmentectomy will be a standard treatment if the superior pulmonary function and noninferiority in overall survival are confirmed.
目前尚无关于非小细胞肺癌患者行解剖性肺段切除术与肺叶切除术的围手术期并发症的直接比较报道。
我们开展了一项随机对照临床试验，旨在确认与肺叶切除术相比，解剖性肺段切除术在预后方面不劣效（临床试验注册号：JCOG0802/WJOG4607L）。纳入的患者为直径≤2cm 的外周型浸润性非小细胞肺癌。将这些患者随机分为行肺叶切除术或肺段切除术的两组。主要终点为总生存。在此，我们重点关注了围手术期并发症和死亡率。采用手术方式评估了手术并发症的预测因素。根据手术方式将肺段切除术分为简单肺段切除术和复杂肺段切除术。右肺或左肺的上叶、舌叶或段 6 切除定义为简单肺段切除术。其他肺段切除定义为复杂肺段切除术。本临床试验已在日本大学医院医疗信息网络临床试验注册库（UMIN000002317）进行了注册。
2009 年 8 月 10 日至 2014 年 10 月 21 日期间，共纳入 1106 例患者（肺叶切除术 554 例，肺段切除术 552 例）。无手术相关死亡病例。肺叶切除术组和肺段切除术组的并发症（≥2 级）发生率分别为 26.2%和 27.4%（P=0.68）。肺叶切除术组和肺段切除术组的吻合口瘘/肺漏气（≥2 级）发生率分别为 3.8%和 6.5%（P=0.04）。多变量分析显示，肺漏气和脓胸（≥2 级）等肺部并发症的预测因素包括复杂肺段切除术（与肺叶切除术相比）（比值比，2.07；95%置信区间，1.11-3.88；P=0.023）和吸烟>20 包/年（比值比，2.61；95%置信区间，1.14-5.97；P=0.023）。
除了肺段切除术组的肺漏气发生率更高外，肺段切除术组和肺叶切除术组患者的术中及术后几乎所有术后并发症测量指标均无差异。如果能证实肺段切除术在保留患者较高的肺功能的同时不劣效于肺叶切除术，那么肺段切除术将成为一种标准的治疗方法。
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