Stoffels Ingo, Herrmann Ken, Rekowski Jan, Jansen Philipp, Schadendorf Dirk, Stang Andreas, Klode Joachim
Department of Dermatology, Venerology and Allergology, University-Hospital Essen, University of Duisburg-Essen, 45122, Essen, Germany.
West German Cancer Center, University Duisburg-Essen, 45122, Essen, Germany.
Trials. 2019 Feb 4;20(1):99. doi: 10.1186/s13063-019-3197-7.
Melanoma has become a growing interdisciplinary problem in public health worldwide. According to the World Health Organization, the incidence of melanoma is increasing faster than any other cancer in the world. Because melanoma metastasizes early into the regional lymph nodes, sentinel lymph node excision (SLNE) is included in the current American Joint Committee of Cancer guidelines. However SLNE of melanoma has a high false-negative rate of up to 44%.
The gold standard for detection and extirpation of the sentinel lymph node is preoperative lymphoscintigraphy. SPECT/CT provides complementary information: the advantages include accurate anatomical localization, identification of false positives, reduction in the number of false negatives, and alteration of the surgical approach. Therefore, sentinel lymph node-SPECT/CT provides valuable information before sentinel lymph node excision and advocates its use in melanoma. We present a multicenter, unblinded superiority randomized controlled trial to compare SPECT/CT-aided SLNE versus standard SLNE in melanoma patients.
The primary efficacy endpoint is distant metastasis-free survival. Secondary endpoints comprise overall survival, disease-free survival, rate of local relapses within the follow-up period (false-negative rate of sentinel lymph node), number of positive sentinel lymph nodes (sensitivity, false-positive rate), complication rate, quality of life, quality-adjusted life years, inpatient days, and overall costs during hospital stays.
ClinicalTrials.gov, NCT03683550 . Registered on 20 September 2018.
黑色素瘤已成为全球公共卫生领域一个日益严重的跨学科问题。根据世界卫生组织的数据，黑色素瘤的发病率增长速度超过世界上任何其他癌症。由于黑色素瘤早期会转移至区域淋巴结，前哨淋巴结切除（SLNE）被纳入当前美国癌症联合委员会的指南中。然而，黑色素瘤的前哨淋巴结切除存在高达44%的高假阴性率。
前哨淋巴结检测和切除的金标准是术前淋巴闪烁显像。SPECT/CT提供补充信息：其优点包括准确的解剖定位、识别假阳性、减少假阴性数量以及改变手术方式。因此，前哨淋巴结-SPECT/CT在进行前哨淋巴结切除前可提供有价值的信息，并提倡在黑色素瘤中使用。我们开展了一项多中心、非盲优效性随机对照试验，以比较SPECT/CT辅助的前哨淋巴结切除与标准前哨淋巴结切除在黑色素瘤患者中的效果。
主要疗效终点是无远处转移生存期。次要终点包括总生存期、无病生存期、随访期内局部复发率（前哨淋巴结假阴性率）、前哨淋巴结阳性数量（敏感性、假阳性率）、并发症发生率、生活质量、质量调整生命年、住院天数以及住院期间的总费用。
ClinicalTrials.gov，NCT03683550。于2018年9月20日注册。
