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)

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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.