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一种用于黑色素瘤和泌尿生殖系统恶性肿瘤腹股沟淋巴结清扫术的微创方法:一项尝试性随机对照试验的长期结果。

A Minimally Invasive Approach for Inguinal Lymphadenectomy in Melanoma and Genitourinary Malignancy: Long-Term Outcomes in an Attempted Randomized Control Trial.

机构信息

Division of Surgical Oncology, Department of Surgery, Winship Cancer Institute, Emory University, Atlanta, GA, USA.

Department of Urology, Winship Cancer Institute, Emory University, Atlanta, GA, USA.

出版信息

Ann Surg Oncol. 2017 Oct;24(11):3237-3244. doi: 10.1245/s10434-017-5971-7. Epub 2017 Aug 2.

Abstract

BACKGROUND

Open inguinal lymphadenectomy (OIL) has a high incidence of complications. The authors adapted and reported a minimally invasive technique [videoscopic inguinal lymphadenectomy (VIL)] for use with melanoma, subsequently pursuing a randomized, prospective trial comparing open and minimally invasive approaches in an attempt to confirm retrospective findings illustrating reduced complications with the minimally invasive approach.

METHODS

A randomized, prospective trial (NCT01526486) was designed to compare outcomes for patients undergoing VIL versus OIL. Patients with a diagnosis of malignancies requiring inguinal lymphadenectomy at Emory University were enrolled in the study, and informed consent was obtained. Failure to accrue sufficient patients resulted in suspension of the randomization process. Clinicopathologic, procedural, and outcomes data on VILs were prospectively collected. The primary outcome was wound complications, and the secondary outcome was recurrence-free survival.

RESULTS

The results are limited to VILs. In this study, 102 patients underwent 137 procedures. Most of the complications were Clavien-Dindo 1 or 2, accounting for 89.7% of all postoperative issues. The wound infection rate was 47.4%. Skin necrosis or wound dehiscence occurred after 13 of the procedures (9.5%). For the patients with melanoma, the median overall survival was 68.8 months, and the recurrence-free survival was 18.5 months. The median inguinal recurrence-free survival was not reached. The median stage-specific recurrence-free survival was not reached for stage IIIA, was 22.8 months for stage IIIB, and was 8.8 months for stage IIIC disease (p < 0.001).

CONCLUSIONS

The long-term findings presented in this report expand on and confirm previously published results demonstrating decreased morbidity and oncologic noninferiority of VIL, further validating the technique for patients requiring lymphadenectomy.

摘要

背景

开放式腹股沟淋巴结清扫术(OIL)并发症发生率较高。作者改良并报道了一种用于黑色素瘤的微创技术[腔镜腹股沟淋巴结清扫术(VIL)],随后进行了一项随机、前瞻性试验,比较开放式和微创方法,试图证实微创方法降低并发症的回顾性发现。

方法

设计了一项随机、前瞻性试验(NCT01526486),比较 VIL 与 OIL 治疗患者的结果。在埃默里大学被诊断患有需要腹股沟淋巴结清扫术的恶性肿瘤的患者入组本研究,并获得了知情同意。由于未能获得足够的患者,随机过程被暂停。前瞻性收集 VIL 的临床病理、手术和结局数据。主要结局是伤口并发症,次要结局是无复发生存率。

结果

结果仅限于 VIL。在这项研究中,102 例患者接受了 137 次手术。大多数并发症为 Clavien-Dindo 1 级或 2 级,占所有术后问题的 89.7%。伤口感染率为 47.4%。13 例患者出现皮肤坏死或伤口裂开(9.5%)。对于黑色素瘤患者,总生存中位数为 68.8 个月,无复发生存率为 18.5 个月。腹股沟无复发生存中位数未达到。ⅢA 期的中位分期特异性无复发生存中位数未达到,ⅢB 期为 22.8 个月,ⅢC 期为 8.8 个月(p<0.001)。

结论

本报告中的长期发现扩展并证实了先前发表的结果,表明 VIL 降低了发病率和肿瘤学非劣效性,进一步验证了该技术对需要淋巴结清扫术的患者的有效性。

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