Kuru Oğuzhan, Topuz Samet, Sen Serhat, Iyibozkurt Cem, Berkman Sinan
Department of Obstetrics and Gynecology, İstanbul Faculty of Medicine, İstanbul University, İstanbul, Turkey.
J Turk Ger Gynecol Assoc. 2011 Dec 1;12(4):204-8. doi: 10.5152/jtgga.2011.52. eCollection 2011.
To measure the feasibility of sentinel lymph node technique in endometrial cancer.
The study was designed as a prospective non-randomized case-control trial. Between 2010-2011, in Istanbul University, Istanbul Medical Faculty, Gynecologic Oncology department, 26 patients who were preoperatively evaluated as endometrial cancer enrolled in the study. Patients' detailed informed consent and ethics committee approval were obtained. Sentinel lymph node (SLN) detection rate was determined as the primary outcome. Sensitivity, specificity, positive and negative predictive values and particularly false negative results were determined as secondary outcomes. As a technique of SLN, injection of methylene blue to the subserosal myometrium of the uterine fundus via 5 cc syringe following peritoneal aspiration cytology procedure was obtained. Surgery was made after injection for an average of 5 minutes due to the physiological spread of the blue dye. Then, the standard protocol of hysterectomy was performed and the retroperitoneum was opened to perform lymphadenectomy. The presence of lymph node regions, and presence of a sentinel node was recorded on the trial record form. Positive staining nodes were sent separately for pathological examination. In the course of the study due to insufficient rate of staining, the technique has been changed to cervical and multiple uterine injections.
As the primary outcome, an SLN positivity rate of 23% in 6 patients with a total of 8 lymph nodes were found. The remarkable finding was that in the first technique, the rate was 1/16 (6%), while the second technique, 5/10 (50%), respectively. The difference is statistically significant (p=0.001). In endometrial cancer stage I and II, secondary outcomes for sensitivity, specificity, positive predictive value, negative predictive value were 23%, 0%, 100%, 43%, respectively. Because there were no metastatic lymph nodes found, false negative rate was 0%.
SLN approach is not valuable enough to eliminate the need for lymphadenectomy. On the other hand, it facilitates scanning micrometastases and ultrastaging, while its clinical value has not yet been established. However, according to the recent pilot studies, it provides a means for assessing micrometastases for the medium-risk group for local recurrence.
评估前哨淋巴结技术在子宫内膜癌中的可行性。
本研究设计为前瞻性非随机病例对照试验。2010年至2011年间，在伊斯坦布尔大学伊斯坦布尔医学院妇科肿瘤科，26例术前评估为子宫内膜癌的患者纳入研究。获得了患者详细的知情同意书并经伦理委员会批准。以前哨淋巴结（SLN）检出率作为主要结局。将灵敏度、特异度、阳性和阴性预测值，尤其是假阴性结果作为次要结局。作为SLN技术，在腹腔穿刺细胞学检查后，通过5毫升注射器向子宫底浆膜下肌层注射亚甲蓝。由于蓝色染料的生理性扩散，注射后平均5分钟进行手术。然后，按照子宫切除的标准术式进行操作，并打开后腹膜进行淋巴结清扫。在试验记录表上记录淋巴结区域的存在情况以及前哨淋巴结的存在情况。对染色阳性的淋巴结分别进行病理检查。在研究过程中，由于染色率不足，技术改为宫颈及多处子宫注射。
作为主要结局，在总共8个淋巴结的6例患者中，SLN阳性率为23%。显著的发现是，在第一种技术中，该率为1/16（6%），而在第二种技术中，为5/10（50%），差异具有统计学意义（p = 0.001）。在子宫内膜癌I期和II期，灵敏度、特异度、阳性预测值、阴性预测值的次要结局分别为23%、0%、100%、43%。由于未发现转移淋巴结，假阴性率为0%。
前哨淋巴结方法在消除淋巴结清扫需求方面的价值不足。另一方面，它有助于扫描微转移和超分期，但其临床价值尚未确立。然而，根据最近的初步研究，它为评估局部复发中风险组的微转移提供了一种手段。
