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随机对照试验研究临床颈部淋巴结阴性的甲状腺微小乳头状癌患者预防性中央区淋巴结清扫术的效果。

Randomized trial of prophylactic ipsilateral central lymph node dissection in patients with clinically node negative papillary thyroid microcarcinoma.

机构信息

Department of Otorhinolaryngology-Head and Neck Surgery, Sanggye Paik Hospital, College of Medicine, Inje University, Seoul, Republic of Korea.

Graduate School of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.

出版信息

Eur Arch Otorhinolaryngol. 2020 Feb;277(2):569-576. doi: 10.1007/s00405-019-05702-3. Epub 2019 Oct 29.

Abstract

PURPOSE

This study aimed to evaluate the role of prophylactic ipsilateral central neck dissection (pCND) in patients with clinically node-negative (cN0) papillary thyroid microcarcinoma (PTMC).

METHODS

In this randomized control trial, a total of 164 consecutive patients were enrolled. By double-blinded randomization protocol, patients were allocated into hemithyroidectomy with pCND (n = 82) or without pCND (n = 82). With intention-to-treat analysis, post-surgical pathological and clinical course, surgery-related complications, causes and clinical course of protocol-violated cases and 5-year recurrence-free survival were compared.

RESULTS

Operation time, hospital stay, and post-surgical complication were not significantly different between the two groups. In the pCND (+) group, occult lymph node metastasis rate was 50.0%, and lymph node ratio (metastatic/harvested lymph nodes) was 45.2%. Ten patients in the pCND (+) group had converted to undergo onsite or staged completion total thyroidectomy due to the presence of metastatic central lymph nodes and/or positive resection margin. Until last follow-up (mean 73.4 months), one regional recurrence developed in the pCND (-) group, and three regional recurrences occurred in the pCND (+) group. Five-year recurrence-free survival was similar between the two groups.

CONCLUSION

Although ipsilateral pCND could clear occult lymph node metastasis in the central compartment, it failed to provide any oncological benefit for cN0 PTMC patients.

摘要

目的

本研究旨在评估预防性同侧中央颈部清扫术(pCND)在临床淋巴结阴性(cN0)甲状腺微小乳头状癌(PTMC)患者中的作用。

方法

在这项随机对照试验中,共纳入了 164 例连续患者。通过双盲随机分组方案,将患者分为行甲状腺叶切除术伴 pCND(n=82)或不伴 pCND(n=82)的两组。采用意向性治疗分析,比较术后病理和临床过程、手术相关并发症、方案违反病例的原因和临床过程以及 5 年无复发生存率。

结果

两组的手术时间、住院时间和术后并发症无显著差异。在 pCND(+)组中,隐匿性淋巴结转移率为 50.0%,淋巴结比(转移/采集淋巴结)为 45.2%。由于中央淋巴结转移和/或阳性切缘,10 例 pCND(+)组患者转为行同期或分期全甲状腺切除术。截至最后一次随访(平均 73.4 个月),pCND(-)组出现 1 例区域复发,pCND(+)组出现 3 例区域复发。两组 5 年无复发生存率相似。

结论

尽管同侧 pCND 可以清除中央区隐匿性淋巴结转移,但对 cN0 PTMC 患者无任何肿瘤学获益。

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