NSCLC NCCN2016V4 PRINCIPLES OF DIAGNOSTIC EVALUATION
诊断评估原则

* Patients with a strong clinical suspicion of stage I or II lung cancer (based on risk factors and radiologic appearance) do not require a biopsy before surgery.山东省肿瘤医院呼吸肿瘤内科张品良
*临床高度怀疑I或II期肺癌的患者（基于危险因素和影像学表现）不需要术前活检。

△A biopsy adds time, costs, and procedural risk and may not be needed for treatment decisions.
△活检增加时间、成本和诉讼风险，治疗决策可能不需要。

△A preoperative biopsy may be appropriate if a non-lung cancer diagnosis is strongly suspected that can be diagnosed by core biopsy or fine-needle aspiration (FNA).
△如果强烈怀疑非肺癌诊断，术前活检可能是恰当的，可经空芯针活检或细针穿刺（FNA）确诊。

△A preoperative biopsy may be appropriate if an intraoperative diagnosis appears difficult or very risky.
△如果术中诊断看上去好像困难或非常危险，术前活检可能是合理的。

△If a preoperative tissue diagnosis has not been obtained, then an intraoperative diagnosis (ie, wedge resection, needle biopsy) is necessary before lobectomy, bilobectomy, or pneumonectomy.
△如果尚未获得术前诊断，则在双肺叶或全肺切除术之前必须术中诊断（即楔形切除、针吸活检）。

* Bronchoscopy should preferably be performed during the planned surgical resection, rather than as a separate procedure.
*支气管镜检查最好是在计划的手术切除期间，而不是作为一个单独的措施。

△Bronchoscopy is required before surgical resection (see NSCL-2).
△术前要求支气管镜检查（见NSCL-2）。

△A separate bronchoscopy may not be needed for treatment decisions before the time of surgery and adds time, costs, and procedural risk.
△在手术过程之前可能不需要单独的支气管镜检查来确定治疗决策，因增加时间、费用和诉讼风险。

△A preoperative bronchoscopy may be appropriate if a central tumor requires pre-resection evaluation for biopsy, surgical planning (eg, potential sleeve resection), or preoperative airway preparation (eg, coring out an obstructive lesion).
△中心性肿瘤如果需要切除前评估，术前支气管镜对于活检、手术计划（如，袖状切除的可能性）或术前气道准备（如，阻塞性病变钻心复张）可能是合适的。

* Invasive mediastinal staging is recommended before surgical resection for most patients with clinical stage I or II lung cancer (see NSCL-2).
*对于大多数临床I或II期肺癌患者在手术切除前建议纵隔分期（见NSCL-2）。

△Patients should preferably undergo invasive mediastinal staging as the initial step before the planned resection (during the same anesthetic procedure), rather than as a separate procedure.
△在计划的切除术前患者最好接受侵袭性纵隔分期作为最初的步骤（在同一的麻醉过程中），而不是作为一个单独的措施。

△A separate staging procedure adds time, costs, coordination of care, inconvenience, and an additional anesthetic risk.
△单独的分期程序增加了时间、成本、护理协调、不便和额外的麻醉风险。

△Preoperative invasive mediastinal staging may be appropriate for a strong clinical suspicion of N2 or N3 nodal disease or when intraoperative cytology or frozen section analysis is not available.
△对于临床高度怀疑N2或N3淋巴结病变或无法获得术中细胞学或冰冻切片分析时，术前侵袭性纵隔分期可能是合理的。

* In patients with suspected non-small cell lung cancer (NSCLC), many techniques are available for tissue diagnosis.
*在可疑非小细胞肺癌（NSCLC）患者中，许多技术可用于组织学诊断。

△Diagnostic tools that should be routinely available include:
△可以获得的常规诊断工具应包括：

→ Sputum cytology
→ 痰细胞学检查

→ Bronchoscopy with biopsy and transbronchial needle aspiration (TBNA)
→ 支气管镜活检和经支气管针吸活检（TBNA）

→ Image-guided transthoracic needle core biopsy (preferred) or FNA
→ 影像引导下经皮肺穿刺活检（首选）或细针穿刺活检

→ Thoracentesis
→ 胸腔穿刺术

→ Mediastinoscopy
→ 纵隔镜检查

→ Video-assisted thoracic surgery (VATS) and open surgical biopsy
→ 电视胸腔镜手术（VATS）和开放手术活检

△Diagnostic tools that provide important additional strategies for biopsy include:
△可提供其他重要策略的活检诊断工具包括：

→ Endobronchial ultrasound (EBUS)–guided biopsy
→ 支气管内超声（EBUS）引导下活检

→ Endoscopic ultrasound (EUS)–guided biopsy
→ 内镜超声（EUS）引导下活检

→ Navigational bronchoscopy
→ 导航支气管镜

* The preferred diagnostic strategy for an individual patient depends on the size and location of the tumor, the presence of mediastinal or distant disease, patient characteristics (such as pulmonary pathology and/or other significant comorbidities), and local experience and expertise.
*个体患者首选的诊断策略取决于肿瘤的大小和位置、存在纵隔或远隔病变、患者特征（如肺病理学和/或其他重要的合并症）以及本地医生的经验和专业知识。

△Factors to be considered in choosing the optimal diagnostic step include:
△选择最佳诊断步骤应考虑的因素包括：

→ Anticipated diagnostic yield (sensitivity)
→ 预期的诊断阳性率（敏感性）

→ Diagnostic accuracy including specificity and particularly the reliability of a negative diagnostic study (ie, true negative)
→ 诊断准确性包括特异性，特别是阴性诊断的可靠性（即，真阴性）

→ Adequate volume of tissue specimen for diagnosis and molecular testing
→ 用于诊断和分子检测的组织标本足够大

→ Invasiveness and risk of procedure
→ 操作的侵袭性与风险

→ Efficiency of evaluation
→ 评估的效能

– Access and timeliness of procedure
– 操作的获取和时效性

– Concomitant staging is beneficial, because it avoids additional biopsies or procedures.
– 同时分期是有益的，因为这避免了额外的活检或步骤。

It is preferable to biopsy the pathology that would confer the highest stage (ie, to biopsy a suspected metastasis or mediastinal lymph node rather than the pulmonary lesion).
最高级别的活检病理更好（即，对可疑转移灶或纵隔淋巴结而非肺部病变进行活检）。

Therefore, PET imaging is frequently best performed before a diagnostic biopsy site is chosen in cases of high clinical suspicion for aggressive, advanced-stage tumors.
因此，在临床高度怀疑侵袭性、晚期肿瘤的情况下，在选择诊断活检部位之前，进行PET成像常常是最佳的。

→ Technologies and expertise available
→ 现有的技术和专业知识

→ Tumor viability at proposed biopsy site from PET imaging.
→ PET成像提议的活检部位的肿瘤活性。

△Decisions about the optimal diagnostic steps for suspected stage I to III lung cancer should be made by thoracic radiologists, interventional radiologists, and board-certified thoracic surgeons who devote a significant portion of their practice to thoracic oncology.
△疑似I-III期肺癌诊断的最佳步骤应该由胸部放射科医师、介入放射科医师以及将胸部肿瘤作为其实践的重要部分、通过职业认证的胸外科医生决定。

Multidisciplinary evaluation should also include a pulmonologist or thoracic surgeon with expertise in advanced bronchoscopic techniques for diagnosis.
多学科评估还应包括具有先进支气管镜诊断专业技巧的肺脏专家或胸外科医生。

△The least invasive biopsy with the highest yield is preferred as the first diagnostic study.
△首次诊断检查首选收益最高、侵袭性最小的活检。

→ Patients with central masses and suspected endobronchial involvement should undergo bronchoscopy.
→ 中心性肿块以及怀疑支气管受累的患者应行支气管镜检查。

→ Patients with peripheral (outer one-third) nodules may benefit from navigational bronchoscopy, radial EBUS, or TTNA.
→ 周围性（外1/3）结节患者可能受益于导航支气管镜、径向支气管内超声（EBUS）或经胸腔针吸活检（TTNA）。

→ Patients with suspected nodal disease should be biopsied by EBUS, EUS, navigational bronchoscopy, or mediastinoscopy.
→ 具有可疑淋巴结病变的患者应通过支气管内超声（EBUS）、超声内镜（EUS）、导航支气管镜或纵隔镜活检。

– EBUS provides access to nodal stations 2R/2L, 4R/4L, 7, 10R/10L, and other hilar nodal stations if necessary.
– 如有必要，支气管内超声（EBUS）可进入2R/2L、4R/4L、7、10R/10L和肺门淋巴结区。

– EUS–guided biopsy provides additional access to stations 5, 7, 8, and 9 lymph nodes if these are clinically suspicious.
– 超声内镜（EUS）引导的穿刺活检可进一步进入5、7、8和9淋巴结区，如果这些区域临床可疑。

– TTNA and anterior mediastinotomy (ie, Chamberlain procedure) provide additional access to anterior mediastinal (station 5 and 6) lymph nodes if these are clinically suspicious.
– 经胸腔针吸活检（TTNA）和前纵隔切开术（即Chamberlain手术）可进一步进入前纵隔（5和6区）淋巴结，如果这些临床可疑。

→ EUS also provides reliable access to the left adrenal gland.
→ 超声内镜（EUS）同样可以可靠地进入左侧肾上腺。

→ Lung cancer patients with an associated pleural effusion should undergo thoracentesis and cytology.
→ 合并胸腔积液的肺癌患者应进行胸腔穿刺细胞学检查。

A negative cytology result on initial thoracentesis does not exclude pleural involvement.
初始穿刺细胞学阴性并不能排除胸膜受累。

An additional thoracentesis and/or thoracoscopic evaluation of the pleura should be considered before starting curative intent therapy.
在开始根治性治疗前，应该考虑追加胸腔穿刺和/或胸腔镜胸膜评估。

→ Patients suspected of having a solitary site of metastatic disease should have tissue confirmation of that site if feasible.
→ 怀疑有孤立性转移灶的患者，如果可行的话，该病灶应该有组织学证实。

→ Patients suspected of having metastatic disease should have confirmation from one of the metastatic sites if feasible.
→ 怀疑有转移性疾病的患者，如果可行的话，应该确认其中的一个转移灶。

→ Patients who may have multiple sites of metastatic disease-based on a strong clinical suspicion—should have biopsy of the primary lung lesion or mediastinal lymph nodes if it is technically difficult or very risky to biopsy a metastatic site.
→ 可能有多部位转移性疾病的患者——根据临床强烈怀疑——如果技术上困难或转移部位活检非常危险，应该活检肺原发灶或纵隔淋巴结。