一种新型结节定位装置在甲状腺手术的应用

Application of a Novel Nodule Positioning Device in Thyroid Surgery

摘要: 背景与目的：甲状腺结节的发病率逐年升高，手术切除为甲状腺小结节的病理诊断和治疗提供了理想方法，但是对小结节的定位成为手术过程中的一大难题。本研究的目的在于明确一种新型甲状腺结节定位装置在甲状腺手术中的可行性和安全性。方法：在超声引导下，运用该定位装置在术前对有强烈手术意愿的患者进行甲状腺结节精准定位。随后对该项技术进行回顾性研究，以评估该新型定位技术的安全性和可行性。主要结局指标包括探究该项定位技术的安全性(定位过程是否导致出血以及其他不良反应)和成功率(能否精准定位甲状腺微小结节并且将其成功切除)；次要结局指标包括可行性(定位过程持续时间以及定位装置是否失败和损坏)。结果：共对29例甲状腺切除手术患者的29个甲状腺微小结节进行术前精准定位。总体而言，28例患者的甲状腺微小结节被成功精准定位并切除，未出现术中定位钩子断裂或者脱落的情况。1例患者出现了结节与定位针钩子之间存在距离偏差，最终扩大切除范围后才将结节切除。其中结节直径大小中位数为0.5 cm，定位过程的时间平均数为13 min。没有病人在手术过程中或术后出现明显的相关并发症。结论：在甲状腺手术中使用该定位装置安全可靠，具有较高的定位成功率，能提高对甲状腺疾病的诊断率，同时也方便临床手术医生操作。是一种具有一定临床应用价值的结节精准定位技术。

Abstract: Background & Objective: The incidence of thyroid nodules is increasing year by year. Surgical resection provides an ideal method for the pathologic diagnosis and treatment of thyroid nodules, but the localization of nodules is a major problem in the surgical process. The objective of this study was to determine the feasibility and safety of a novel thyroid nodule localization device in thyroid surgery. Methods: Under the guidance of ultrasound, the localization device was used to accurately locate thyroid nodules in patients with a strong desire for surgery. Subsequently, a retrospective study was conducted to evaluate the safety and feasibility of this novel positioning technology. Primary outcome measures included examining the safety of the localization technique (whether the localization process resulted in bleeding and other adverse effects) and success rate (whether the tiny thyroid nodules could be accurately located and successfully removed). Secondary outcome measures include feasibility (duration of the positioning process and whether the positioning device fails and is damaged). Results: A total of 29 thyroid micronodules in 29 patients undergoing thyroidectomy were accurately located before the operation. Overall, the thyroid micronodules were successfully located and removed in 28 patients without intraoperative location hook breakage or loss. In 1 patient, there was a distance deviation between the nodules and the positioning needle hook, and the nodules were removed only after the scope of resection was expanded. The median diameter of nodules was 0.5cm. The average time of the positioning process was 13 minutes. None of the patients had significant complications during or after the procedure. Conclusion: The localization device is safe and reliable in thyroid surgery, and has a high localization success rate, which can improve the diagnosis rate of thyroid diseases and facilitate the operation of clinical surgeons. It is an accurate nodule localization technique with a certain clinical application value.