Wang Jianli, Lu Yan, Li Fei, Yao Desheng
Department of Gynecologic Oncology, Guangxi Medical University Cancer Hospital, Nanning, Guangxi Zhuang Autonomous Region, P.R. China.
PLoS One. 2024 Dec 2;19(12):e0311144. doi: 10.1371/journal.pone.0311144. eCollection 2024.
Lower limb lymphedema (LLL) is a common postoperative complication following lymphadenectomy in cervical and endometrial cancers. Removal of the circumflex iliac nodes distal to the external iliac node (CINDEIN) is associated with LLL. Here, we sought to evaluate whether preserving the CINDEIN is helpful in reducing the incidence of LLL in women with cervical and endometrial cancers and to evaluate the safety of preserving CINDEIN. In this prospective randomized controlled trial, patients with clinical stage I A2 to II A cervical cancer and stage I to III endometrial carcinoma undergoing surgery were randomly assigned (1:1) to undergo pelvic lymphadenectomy with CINDEIN removal or preservation. The primary endpoint was the incidence of LLL at 24 months post-surgery. Eligible patients underwent sentinel lymph node (SLN) mapping with carbon nanoparticles (CNP). The study was registered with ClinicalTrials.gov, number ChiCTR2300071911. Between Jun 1, 2017, and Dec 31, 2018, 328 participants were randomly assigned to the two groups. Thirteen patients were excluded from the lymphedema analysis. A total of 158 patients in the CINDEIN preservation group and 157 in the CINDEIN removal group completed the follow-up examination. At baseline, no significant differences were observed between the two groups. The 3-year overall survival rate was 96.9% in the preservation group and 95.7% in the resection group. For cervical cancer and endometrial carcinoma, the incidence of LLL were significantly lower in the preservation group than in the removal group both at 24 months. No differences in the occurrence time of LLL were observed between the two groups. The LLL stages also showed no significant difference between the two groups. In the removal group, no CINDEIN metastases were identified in any patient. A total of 125 evaluable patients received the injection of CNP. None of the patients had CINDEIN detected as SLNs. CINDEIN removal is an important risk factor for LLL following lymphadenectomy in cervical and endometrial cancers. The metastasis rate of CINDEIN in cervical cancer and early endometrial cancer is relatively low, and preserving CINDEIN might be safe and helpful in reducing the occurrence of LLL.
下肢淋巴水肿（LLL）是宫颈癌和子宫内膜癌淋巴结清扫术后常见的并发症。切除髂外淋巴结远端的旋髂淋巴结（CINDEIN）与LLL相关。在此，我们试图评估保留CINDEIN是否有助于降低宫颈癌和子宫内膜癌女性患者LLL的发生率，并评估保留CINDEIN的安全性。在这项前瞻性随机对照试验中，将接受手术治疗的临床分期为IA2至IIA期的宫颈癌患者和I至III期的子宫内膜癌患者随机分配（1:1），分别接受切除或保留CINDEIN的盆腔淋巴结清扫术。主要终点是术后24个月时LLL的发生率。符合条件的患者接受了碳纳米颗粒（CNP）前哨淋巴结（SLN）定位。该研究已在ClinicalTrials.gov注册，注册号为ChiCTR2300071911。在2017年6月1日至2018年12月31日期间，328名参与者被随机分配到两组。13名患者被排除在淋巴水肿分析之外。CINDEIN保留组共有158例患者，CINDEIN切除组有157例患者完成了随访检查。在基线时，两组之间未观察到显著差异。保留组的3年总生存率为96.9%，切除组为95.7%。对于宫颈癌和子宫内膜癌，保留组术后24个月时LLL的发生率均显著低于切除组。两组之间LLL的发生时间没有差异。两组之间LLL的分期也没有显著差异。在切除组中，未在任何患者中发现CINDEIN转移。共有125名可评估患者接受了CNP注射。没有患者检测到CINDEIN为SLN。在宫颈癌和子宫内膜癌淋巴结清扫术后，切除CINDEIN是LLL的一个重要危险因素。CINDEIN在宫颈癌和早期子宫内膜癌中的转移率相对较低，保留CINDEIN可能对降低LLL的发生是安全且有帮助的。
