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一项随机对照临床试验:临床淋巴结阴性甲状腺乳头状癌患者预防性中央颈部淋巴结清扫术无明显获益。

A Randomized Controlled Clinical Trial: No Clear Benefit to Prophylactic Central Neck Dissection in Patients With Clinically Node Negative Papillary Thyroid Cancer.

机构信息

Division of Endocrine Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.

Division of Otolaryngology, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.

出版信息

Ann Surg. 2020 Sep 1;272(3):496-503. doi: 10.1097/SLA.0000000000004345.

Abstract

OBJECTIVE

The aim of this prospective randomized-controlled trial was to evaluate the risks/benefits of prophylactic central neck dissection (pCND) in patients with clinically node negative (cN0) papillary thyroid cancer (PTC).

BACKGROUND

Microscopic lymph node involvement in patients with PTC is common, but the optimal management is unclear.

METHODS

Sixty patients with cN0 PTC were randomized to a total thyroidectomy (TT) or a TT+ pCND. All patients received postoperative laryngoscopies and standardized radioiodine treatment. Thyroglobulin (Tg) levels and/or neck ultrasounds were performed at 6 weeks, 6 months, and 1 year.

RESULTS

Tumors averaged 2.2 ± 0.2 cm and 11.9% had extra-thyroidal extension. Thirty patients underwent a pCND and 27.6% had positive nodes (all ≤6 mm). Rates of postoperative PTH < 10 (33.3% vs 24.1%, P = 0.57) and transient nerve dysfunction (13.3% vs 10.3%, P = 1.00) were not significantly different between groups. Six weeks after surgery, both TT and TT + pCND were equally likely to achieve a Tg < 0.2 (54.5% vs 66.7%, P = 0.54) and/or a stimulated Tg (sTg) <1 (59.3% vs 64.0%, P = 0.78). At 1 year, rates of Tg < 0.2 (88.9% vs 90.0%, P = 1.00) and sTg < 1 (93.8% vs 92.3%, P = 1.00) remained similar between groups. Neck ultrasounds at 1 year were equally likely to be read as normal (85.7% in TT vs 85.1% in pCND, P = 1.00).

CONCLUSIONS

cN0 PTC patients treated either with TT or TT + pCND had similar complication rates after surgery. Although microscopic nodes were discovered in 27.6% of pCND patients, oncologic outcomes were comparable at 1 year.

摘要

目的

本前瞻性随机对照试验旨在评估预防性中央颈部清扫术(pCND)在临床淋巴结阴性(cN0)甲状腺乳头状癌(PTC)患者中的风险/获益。

背景

PTC 患者的淋巴结微小浸润很常见,但最佳治疗方法尚不清楚。

方法

60 例 cN0 PTC 患者随机分为全甲状腺切除术(TT)或 TT+pCND。所有患者均接受术后喉镜检查和标准化放射性碘治疗。术后 6 周、6 个月和 1 年进行甲状腺球蛋白(Tg)水平和/或颈部超声检查。

结果

肿瘤平均为 2.2±0.2cm,11.9%有甲状腺外侵犯。30 例患者行 pCND,其中 27.6%有阳性淋巴结(均≤6mm)。术后甲状旁腺激素(PTH)<10(33.3%比 24.1%,P=0.57)和暂时性神经功能障碍(13.3%比 10.3%,P=1.00)的发生率在两组间无显著差异。术后 6 周,TT 和 TT+pCND 均能达到 Tg<0.2(54.5%比 66.7%,P=0.54)和/或刺激 Tg(sTg)<1(59.3%比 64.0%,P=0.78)的可能性相同。1 年后,Tg<0.2(88.9%比 90.0%,P=1.00)和 sTg<1(93.8%比 92.3%,P=1.00)的比例在两组间仍相似。1 年后的颈部超声检查同样可能为正常(TT 组为 85.7%,pCND 组为 85.1%,P=1.00)。

结论

接受 TT 或 TT+pCND 治疗的 cN0 PTC 患者术后并发症发生率相似。尽管在 pCND 患者中有 27.6%发现了微小淋巴结,但 1 年时的肿瘤学结果相当。

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