胸腔镜与内镜超声检查对肺癌纵隔淋巴结分期的比较：一项随机试验。

Mediastinoscopy vs endosonography for mediastinal nodal staging of lung cancer: a randomized trial.

机构信息

Department of Pulmonology, C3-P, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands.

出版信息

JAMA. 2010 Nov 24;304(20):2245-52. doi: 10.1001/jama.2010.1705.

DOI:10.1001/jama.2010.1705

PMID:21098770

Abstract

CONTEXT

Mediastinal nodal staging is recommended for patients with resectable non-small cell lung cancer (NSCLC). Surgical staging has limitations, which results in the performance of unnecessary thoracotomies. Current guidelines acknowledge minimally invasive endosonography followed by surgical staging (if no nodal metastases are found by endosonography) as an alternative to immediate surgical staging.

OBJECTIVE

To compare the 2 recommended lung cancer staging strategies.

DESIGN, SETTING, AND PATIENTS: Randomized controlled multicenter trial (Ghent, Leiden, Leuven, Papworth) conducted between February 2007 and April 2009 in 241 patients with resectable (suspected) NSCLC in whom mediastinal staging was indicated based on computed or positron emission tomography.

INTERVENTION

Either surgical staging or endosonography (combined transesophageal and endobronchial ultrasound [EUS-FNA and EBUS-TBNA]) followed by surgical staging in case no nodal metastases were found at endosonography. Thoracotomy with lymph node dissection was performed when there was no evidence of mediastinal tumor spread.

MAIN OUTCOME MEASURES

The primary outcome was sensitivity for mediastinal nodal (N2/N3) metastases. The reference standard was surgical pathological staging. Secondary outcomes were rates of unnecessary thoracotomy and complications.

RESULTS

Two hundred forty-one patients were randomized, 118 to surgical staging and 123 to endosonography, of whom 65 also underwent surgical staging. Nodal metastases were found in 41 patients (35%; 95% confidence interval [CI], 27%-44%) by surgical staging vs 56 patients (46%; 95% CI, 37%-54%) by endosonography (P = .11) and in 62 patients (50%; 95% CI, 42%-59%) by endosonography followed by surgical staging (P = .02). This corresponded to sensitivities of 79% (41/52; 95% CI, 66%-88%) vs 85% (56/66; 95% CI, 74%-92%) (P = .47) and 94% (62/66; 95% CI, 85%-98%) (P = .02). Thoracotomy was unnecessary in 21 patients (18%; 95% CI, 12%-26%) in the mediastinoscopy group vs 9 (7%; 95% CI, 4%-13%) in the endosonography group (P = .02). The complication rate was similar in both groups.

CONCLUSIONS

Among patients with (suspected) NSCLC, a staging strategy combining endosonography and surgical staging compared with surgical staging alone resulted in greater sensitivity for mediastinal nodal metastases and fewer unnecessary thoracotomies.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00432640.

摘要

背景

对于可切除的非小细胞肺癌（NSCLC）患者，建议进行纵隔淋巴结分期。手术分期存在局限性，导致不必要的开胸手术。目前的指南承认，对于没有纵隔转移的患者，微创性内镜超声检查后进行手术分期（如果内镜超声检查未发现淋巴结转移）是替代立即手术分期的一种方法。

目的

比较 2 种推荐的肺癌分期策略。

设计、地点和患者：2007 年 2 月至 2009 年 4 月期间，在 241 例疑似可切除 NSCLC 患者中进行了一项随机对照多中心试验（根特、莱顿、鲁汶、帕普沃思），这些患者需要根据计算机断层扫描或正电子发射断层扫描进行纵隔分期。

干预

或进行外科分期，或进行内镜超声检查（联合经食管和支气管内超声[EUS-FNA 和 EBUS-TBNA]），如果内镜超声检查未发现淋巴结转移，则进行外科分期。当没有纵隔肿瘤扩散的证据时，进行开胸淋巴结清扫术。

主要观察指标

主要结局是纵隔淋巴结（N2/N3）转移的敏感性。参考标准是手术病理分期。次要结局是不必要开胸手术的发生率和并发症。

结果

241 例患者被随机分为外科分期组（n = 118）和内镜超声组（n = 123），其中 65 例患者还接受了外科分期。外科分期发现 41 例（35%；95%置信区间[CI]，27%-44%）和内镜超声发现 56 例（46%；95%CI，37%-54%）（P =.11）患者存在淋巴结转移，而内镜超声检查后进行外科分期发现 62 例（50%；95%CI，42%-59%）（P =.02）。这对应于 79%（41/52；95%CI，66%-88%）与 85%（56/66；95%CI，74%-92%）（P =.47）和 94%（62/66；95%CI，85%-98%）（P =.02）的敏感性。纵隔镜组中 21 例（18%；95%CI，12%-26%）患者不需要开胸手术，而内镜超声组中 9 例（7%；95%CI，4%-13%）患者不需要开胸手术（P =.02）。两组的并发症发生率相似。