Initial clinical experiences using the intraoperative probe-based parathyroid autofluorescence identification system-PTeye™ during thyroid and parathyroid procedures.
Initial clinical experiences using the intraoperative probe-based parathyroid autofluorescence identification system-PTeye™ during thyroid and parathyroid procedures.
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DOI：
10.1002/jso.26500
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发表时间：
2021-09
影响因子：
2.5
通讯作者：
Solόrzano CC
中科院分区：
文献类型：
--
作者：
Kiernan CM;Thomas G;Baregamian N;Solόrzano CC
美国食品和药物管理局已经批准了一种基于探针的NIRAF检测系统，称为PTeye™，作为无标记术中甲状旁腺识别的辅助工具。由于PTeye™迄今为止仅以“盲态”方式进行研究，因此本研究描述了外科医生在不对器械输出设盲的情况下使用PTeye™时的初步印象。前瞻性招募接受甲状腺和甲状旁腺手术的患者。术中用PTeye™评估靶组织。外科医生对PG识别的信心与PTeye™实时输出的NIRAF参数同时记录。对83例患者前瞻性收集的数据进行了回顾性分析。PTeye™用于在46例甲状旁腺和37例甲状腺手术中询问336个靶组织。PTeye™的总体准确性为94.3%，阳性预测值为93.0%，阴性预测值为100%。所有三名参与的高手术量外科医生均观察到使用PTeye™进行术中PG识别的置信度增加，无论其累积的手术经验水平如何。使用PTeye™进行的基于探头的NIRAF检测是一种有价值的辅助器械，可用于不同培训和经验的外科医生术中识别PG。
The Food and Drug Administration has cleared a probe-based NIRAF detection system called PTeye™ as an adjunct tool for label-free intraoperative parathyroid gland identification. Since PTeye™ has been investigated only in a ‘blinded’ manner to date, this study describes the preliminary impressions of PTeye™ when used by surgeons without being blinded to the device output. Patients undergoing thyroid and parathyroid procedures were prospectively recruited. Target tissues were intraoperatively assessed with PTeye™. The surgeon’s confidence in PG identification was recorded concomitantly with NIRAF parameters that were output in real-time from PTeye™. A retrospective review of prospectively collected data on 83 patients was performed. PTeye™ was used for interrogating 336 target tissues in 46 parathyroid and 37 thyroid procedures. PTeye™ yielded an overall accuracy of 94.3% with a positive predictive value of 93.0% and a negative predictive value of 100%. An increase in confidence for intraoperative PG identification with PTeye™ was observed by all three participating high-volume surgeons, irrespective of their level of accrued surgical experience. Probe-based NIRAF detection with PTeye™ can be a valuable adjunct device to intraoperatively identify PGs for surgeons of varied training and experience.
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