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胸段食管癌根治术中三野与二野淋巴结清扫术的短期疗效:一项随机临床试验。

Three-field versus two-field lymphadenectomy in transthoracic oesophagectomy for oesophageal squamous cell carcinoma: short-term outcomes of a randomized clinical trial.

机构信息

Department of Thoracic Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China.

Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.

出版信息

Br J Surg. 2020 May;107(6):647-654. doi: 10.1002/bjs.11497. Epub 2020 Feb 28.

Abstract

BACKGROUND

The benefit and harm of three-field lymphadenectomy for oesophageal cancer are still unknown. The aim of this study was to compare overall survival and morbidity and mortality between three- and two-field lymphadenectomy in patients with oesophageal squamous cell carcinoma.

METHODS

Between March 2013 and November 2016, patients with squamous cell carcinoma of the middle or distal oesophagus were assigned randomly to open oesophagectomy with three-field (cervical-thoracic-abdominal) or two-field (thoracic-abdominal) lymphadenectomy. No chemo(radio) therapy was given before surgery. This paper reports on the secondary outcomes of the study: pathology and surgical complications.

RESULTS

Some 400 patients were randomized, 200 in each group. A median of 37 (i.q.r. 30-49) lymph nodes were dissected in the three-field group, compared with 24 (18-30) in the two-field group (P < 0·001). Some 43 of 200 patients (21·5 per cent) in the three-field group had cervical lymph node metastasis. More patients in the three-field group had pN3 disease: 21 of 200 (10·5 per cent) versus 10 of 200 (5·0 per cent) (P = 0·040). The rate and severity of postoperative complications were comparable between the two groups, except that six patients in the three-field arm needed reintubation compared with none in the two-field group (3·0 versus 0 per cent; P = 0·030). The 90-day mortality rate was 0 per cent in the three-field group and 0·5 per cent (1 patient) in the two-field group (P = 1·000).

CONCLUSION

Oesophagectomy with three-field lymphadenectomy increased the number of lymph nodes dissected and led to stage migration owing to a 21·5 per cent rate of cervical lymph node metastasis. Postoperative complications were largely comparable between two- and three-field lymphadenectomy. Registration number: NCT01807936 ( https://www.clinicaltrials.gov).

摘要

背景

三野淋巴结清扫术治疗食管癌的获益和危害尚不清楚。本研究旨在比较食管鳞癌患者行三野和二野淋巴结清扫术的总生存和发病率及死亡率。

方法

2013 年 3 月至 2016 年 11 月,中下段食管鳞癌患者被随机分配至行开放食管癌切除术并接受三野(颈胸腹)或二野(胸腹)淋巴结清扫术。术前均未行放化疗。本研究报告了该研究的次要结局:病理和手术并发症。

结果

400 例患者随机分组,每组 200 例。三野组淋巴结清扫中位数为 37(IQR 30-49)枚,二野组为 24(18-30)枚(P<0·001)。三野组中有 43 例(21·5%)患者存在颈淋巴结转移。三野组 pN3 疾病的患者更多:200 例中有 21 例(10·5%),二野组中有 10 例(5·0%)(P=0·040)。两组术后并发症的发生率和严重程度相当,只有三野组有 6 例患者需要再次插管,二野组无此情况(3·0%比 0%;P=0·030)。三野组 90 天死亡率为 0%,二野组为 0·5%(1 例)(P=1·000)。

结论

三野淋巴结清扫术增加了淋巴结清扫的数量,并由于 21·5%的颈淋巴结转移率导致了分期迁移。二野和三野淋巴结清扫术的术后并发症大致相当。注册号:NCT01807936(https://www.clinicaltrials.gov)。

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