Department of Surgery, Royal Derby Hospital, Uttoxeter Road, Derby, DE22 3NE, UK.
Department of Radiology, Royal Derby Hospital, Derby, UK.
Breast Cancer Res Treat. 2021 Jan;185(2):433-440. doi: 10.1007/s10549-020-05961-3. Epub 2020 Oct 6.
The primary aim of this prospective, multicentre feasibility study was to determine whether the biopsied axillary node can be marked using black carbon dye and successfully identified at the time of surgery.
We included breast cancer patients undergoing needle biopsy of the axillary node. The biopsied node was tattooed at the time of needle biopsy (fine needle aspiration or core biopsy) or at a separate visit with black carbon dye (Spot® or Black Eye™). Participants underwent primary surgery or neoadjuvant chemotherapy (NACT) and axillary surgery (SNB or ALND) as per routine care.
110 patients were included. Median age of the women was 59 (range 31-88) years. 48 (44%) underwent SNB and 62 (56%) ALND. Median volume of dye injected was 2.0 ml (range 0.2-4.2). Tattooed node was identified intra-operatively in 90 (82%) patients. The identification rate was higher (76 of 88, 86%) in the primary surgery group compared with NACT (14 of 22, 64%) (p = 0.03). Of those undergoing NACT, the identification rate was better in the patients undergoing SNB (3 of 4, 75%) compared with ALND (11 of 18, 61%) (p > 0.99). The tattooed node was the sentinel node in 78% (28 of 36) patients in the primary surgery group and 100% (3 of 3) in the NACT group. There was no learning curve for surgeons or radiologists. The identification rate did not vary with timing between dye injection and surgery (p = 0.56), body mass index (p = 0.62) or volume of dye injected (p = 0.25).
It is feasible to mark the axillary node with carbon dye and identify it intra-operatively. ClinicalTrials.gov: NCT03640819.
本前瞻性、多中心可行性研究的主要目的是确定在活检时使用黑色碳染料是否可以标记活检的腋窝淋巴结，并在手术时成功识别。
我们纳入了接受腋窝淋巴结经皮穿刺活检的乳腺癌患者。在进行针吸活检（细针抽吸或核心活检）或使用黑色碳染料（Spot®或 Black Eye™）进行单独就诊时，对活检的淋巴结进行纹身。根据常规护理，患者接受了原发性手术或新辅助化疗（NACT）和腋窝手术（SNB 或 ALND）。
共纳入 110 例患者。女性的中位年龄为 59 岁（范围 31-88 岁）。48 例（44%）接受 SNB，62 例（56%）接受 ALND。注射染料的中位数体积为 2.0ml（范围 0.2-4.2）。90 例（82%）患者在术中识别到纹身的淋巴结。原发性手术组的识别率较高（88 例中有 76 例，86%），与 NACT 组（22 例中有 14 例，64%）相比（p=0.03）。在接受 NACT 的患者中，接受 SNB 的患者的识别率更高（4 例中有 3 例，75%），而接受 ALND 的患者的识别率更低（18 例中有 11 例，61%）（p>0.99）。在原发性手术组的 36 例患者中，有 78%（28 例）的纹身淋巴结为前哨淋巴结，在 NACT 组的 3 例患者中，100%（3 例）为前哨淋巴结。外科医生和放射科医生没有学习曲线。识别率与染料注射与手术之间的时间间隔（p=0.56）、体重指数（p=0.62）或染料注射量（p=0.25）无关。
用碳染料标记腋窝淋巴结并在术中识别是可行的。临床试验.gov：NCT03640819。
