Randomized Clinical Trial Comparing Sentinel Lymph Node Excision (SLNE) with or without preoperative hybrid "single-photon emission computed tomography/computed tomography" (SPECT/CT) in Melanoma. (SNEPS-Trial)

比较前哨淋巴结切除术 (SLNE) 与术前混合“单光子发射计算机断层扫描/计算机断层扫描”(SPECT/CT) 治疗黑色素瘤的随机临床试验。

• 批准号: 326107690
• 负责人: Professor Dr. Joachim Klode
• 金额: --
• 依托单位: Klinik für Dermatologie
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 资助国家: 德国
• 项目状态: 未结题
• 来源: https://gepris.dfg.de/gepris/projekt/326107690?language=en
• 关键词: Randomized; Clinical; Trial; Comparing; Sentinel

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 regional lymph nodes, sentinel lymph node (SLN) excision (SLNE) is included in the current AJCC guideline. But SLNE is a cost intensive surgical intervention with potential morbidity that does not offer patients any advantage in overall survival. Moreover SLNE has a high false negative rate of up to 44%. The gold standard for detection and extirpation of the SLN 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 SLN-SPECT/CT provides valuable information before SLNE and advocates its use in melanoma. We plan 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 SLN), number of positive SLN (sensitivity, false positive rate), complication rate, Quality of life (Qol), QALY, inpatient days and overall costs during hospital stays.

黑色素瘤已成为全球公共卫生领域一个日益增长的跨学科问题。根据世界卫生组织的数据，黑色素瘤的发病率增长速度比世界上任何其他癌症都要快。由于黑色素瘤早期转移到局部淋巴结，前哨淋巴结（SLN）切除术（SLNE）被列入当前AJCC指南。但SLNE是一种成本高的手术干预，有潜在的发病率，对患者的总生存期没有任何优势。此外，SLNE的假阴性率高达44%。术前淋巴显像是检测和清除SLN的金标准。SPECT/CT提供了补充信息：其优势包括准确的解剖定位，识别假阳性，减少假阴性数量和改变手术入路。因此，SLN-SPECT/CT在SLNE前提供了有价值的信息，并提倡在黑色素瘤中使用它。我们计划进行一项多中心、非盲随机对照试验，比较SPECT/CT辅助SLNE与标准SLNE在黑色素瘤患者中的应用。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、随访期间局部复发率（SLN假阴性率）、SLN阳性数（敏感性、假阳性率）、并发症发生率、生活质量（Qol）、QALY、住院天数和住院总费用。