Department of Dermatology, Venereology and Allergology, University of Duisburg-Essen, Essen, Germany.
Department of Nuclear Medicine, University of Duisburg-Essen, Essen, Germany.
JAMA Surg. 2015 Jul;150(7):617-23. doi: 10.1001/jamasurg.2014.3502.
IMPORTANCE: The metastatic status of regional lymph nodes is the most relevant prognostic factor in breast cancer, melanoma, and other solid organ tumors with a lymphatic spread. The current gold standard for detection and targeted excision of the sentinel lymph node is preoperative lymphoscintigraphy with technetium Tc 99m. Because of the worldwide shortage of technetium Tc 99m, physicians are looking for nonradioactive dyes for sentinel lymph node labeling. Based on several retrospective studies, the fluorescent dye indocyanine green is considered a possible alternative to technetium Tc 99m. OBJECTIVE: To analyze the feasibility and clinical benefit of intraoperative near infrared fluorescence sentinel lymph node excision (SLNE) compared with standard technetium Tc 99m-guided SLNE using malignant melanoma in which SLNE is firmly established. DESIGN, SETTING, AND PARTICIPANTS: Analysis of a prospective clinical trial at the Skin Cancer Center, University Hospital Essen. Eighty patients with malignant melanoma on the trunk or extremities (upper and lower) who were scheduled to undergo SLNE were included in this study from January 1, 2013, to June 27, 2014. MAIN OUTCOMES AND MEASURES: Concordance of preoperative and intraoperative sentinel lymph node detection rates. RESULTS: During the study period, 80 patients were operated on with an additional intraoperative application of a near infrared fluorescent dye. In these 80 surgical procedures, 147 SLNs were excised. Detection of a technetium Tc 99m-marked SLN before surgery was possible in all cases. Intraoperative visualization of the SLN by indocyanine green before skin incision was successful in only 17 of 80 patients (21%). The number of SLNs identified using the near infrared fluorescence technique in the operative site after skin incision and initial tissue preparation was 141 of 147 (96%). CONCLUSIONS AND RELEVANCE: Among patients in whom the lymph node basin cannot be predicted correctly (eg, in cutaneous melanoma on the trunk), the use of indocyanine green for SLN detection is severely limited compared with SLNE using standard technique guided by technetium Tc 99m. Therefore, SLNE with the use of radiocolloid, followed if possible by single-photon emission computed tomography, remains the gold standard. TRIAL REGISTRATION: German Clinical Trials Register identifier DRKS00004619.
重要性：在乳腺癌、黑色素瘤和其他具有淋巴扩散的实体器官肿瘤中，区域淋巴结的转移状态是最相关的预后因素。目前，检测和靶向切除前哨淋巴结的金标准是术前锝 Tc 99m 淋巴闪烁显像。由于全球锝 Tc 99m 的短缺，医生正在寻找用于前哨淋巴结标记的非放射性染料。基于几项回顾性研究，荧光染料吲哚菁绿被认为是替代锝 Tc 99m 的一种可能选择。
目的：分析术中近红外荧光前哨淋巴结切除（SLNE）与标准锝 Tc 99m 引导的 SLNE 相比的可行性和临床获益，使用黑色素瘤作为已经确立的 SLNE 的基准。
设计、地点和参与者：这是在埃森大学医院皮肤癌中心进行的一项前瞻性临床试验的分析。2013 年 1 月 1 日至 2014 年 6 月 27 日，纳入了 80 例计划接受 SLNE 的躯干或四肢（上下）恶性黑色素瘤患者。
主要结局和测量指标：术前和术中前哨淋巴结检测率的一致性。
结果：在研究期间，80 例患者接受了额外的术中近红外荧光染料应用。在这 80 例手术中，切除了 147 个前哨淋巴结。所有病例均能在术前检测到锝 Tc 99m 标记的 SLN。仅在 80 例患者中的 17 例（21%）成功地在皮肤切开前通过吲哚菁绿术中可视化 SLN。在皮肤切开和初步组织准备后在手术部位使用近红外荧光技术识别的 SLN 数量为 147 个中的 141 个（96%）。
结论和相关性：在无法正确预测淋巴结盆地的患者中（例如，躯干上的皮肤黑色素瘤），与标准技术引导的使用锝 Tc 99m 的 SLNE 相比，吲哚菁绿用于 SLN 检测的用途受到严重限制。因此，使用放射性胶体进行 SLNE，如果可能的话，结合单光子发射计算机断层扫描，仍然是金标准。
试验注册：德国临床试验注册中心标识符 DRKS00004619。
Eur J Nucl Med Mol Imaging. 2012-4-18
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