Wennberg Ebba, Claeson Magdalena, Olofsson Bagge Roger, Polesie Sam, Paoli John
Department of Dermatology and Venereology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden, University of Gothenburg, Gothenburg, Sweden.
Region Västra Götaland, Sahlgrenska University Hospital, Department of Dermatology and Venereology, Gothenburg, Sweden, Sahlgrenska University Hospital, Goteborg, Västra Götaland, Sweden.
BMJ Open. 2025 Apr 2;15(4):e094544. doi: 10.1136/bmjopen-2024-094544.
Sweden has one of the highest incidence rates of cutaneous melanoma globally, and the incidence is rapidly increasing. Melanoma mortality is linked to the thickness of the primary tumour, with thicker melanomas having a poorer prognosis. Thin invasive melanomas (≤1.0 mm Breslow thickness) have excellent prognosis. Traditionally, the surgical approach for melanoma involves a two-step procedure of a diagnostic excision followed by a wide local excision (WLE) with 10 mm clinical margins. The WLE aims to remove potential microsatellites and residual melanoma, which in theory would prevent loco-regional recurrence and could improve survival. However, recent research questions the necessity of WLE for thin invasive melanomas, given their favourable prognosis, minimal risk of microsatellitosis and low rates of residual melanoma found in WLE tissue specimens.
This multicentre, non-inferiority, randomised controlled trial seeks to enrol 2486 patients with thin invasive melanomas that are completely excised with ≥1.5 mm histopathological margins following the diagnostic excision. Patients will be randomly assigned to either a control group that will undergo a WLE with 10 mm clinical margins according to current clinical routine or an experimental group without a WLE. The primary and secondary endpoints are recurrence-free survival at 5 and 10 years, respectively, with tertiary aims including postoperative complications, scar quality, patient satisfaction and quality of life, healthcare resource utilisation as well as differences in biomarkers of recurrent and non-recurrent melanomas. Patients will be assessed at clinical follow-up visits at 3 months as well as at 1, 2, 3, 5 and 10 years.
Approval of this study was obtained from the Swedish Ethical Review Authority (2024-03274-01). The findings of the study will be presented at international scientific meetings and published in peer-reviewed academic journals.
NCT06363591.
瑞典是全球皮肤黑色素瘤发病率最高的国家之一，且发病率正在迅速上升。黑色素瘤死亡率与原发肿瘤厚度相关，肿瘤越厚，预后越差。薄型浸润性黑色素瘤（ Breslow厚度≤1.0毫米）预后良好。传统上，黑色素瘤的手术方法包括两步：先进行诊断性切除，然后进行临床切缘为10毫米的广泛局部切除（WLE）。WLE旨在切除潜在的微卫星灶和残留黑色素瘤，理论上可预防局部区域复发并提高生存率。然而，鉴于薄型浸润性黑色素瘤预后良好、微卫星形成风险极小以及在WLE组织标本中发现的残留黑色素瘤发生率较低，最近的研究对WLE的必要性提出了质疑。
这项多中心、非劣效性、随机对照试验旨在招募2486例薄型浸润性黑色素瘤患者，这些患者在诊断性切除后，组织病理学切缘≥1.5毫米且肿瘤已完全切除。患者将被随机分配至对照组或试验组，对照组按照当前临床常规进行临床切缘为10毫米的WLE，试验组不进行WLE。主要和次要终点分别为5年和10年无复发生存率，三级目标包括术后并发症、瘢痕质量、患者满意度和生活质量、医疗资源利用以及复发和未复发黑色素瘤生物标志物的差异。将在3个月以及1、2、3、5和10年的临床随访中对患者进行评估。
本研究已获得瑞典伦理审查局批准（2024 - 03274 - 01）。研究结果将在国际科学会议上展示，并发表在同行评审的学术期刊上。
NCT06363591。
