低容量甲状腺机构中无甲状旁腺手术经验的自体荧光引导半甲状腺切除术：随机临床试验。
Autofluorescence-guided hemithyroidectomy in a low-volume thyroid institution with no experience in parathyroid surgery: randomized clinical trial.
机构信息
Department of Otorhinolaryngology, Goedstrup Hospital, Herning, Denmark.
Department of Otorhinolaryngology, Head and Neck Surgery, Aarhus University Hospital, Aarhus, Denmark.
出版信息
Br J Surg. 2024 Apr 3;111(4). doi: 10.1093/bjs/znae075.
BACKGROUND
Recent studies suggest that low-volume surgeons with no experience in parathyroid surgery are at increased risk of causing parathyroid gland damage during thyroid surgery. The aim of this RCT was to evaluate the impact of using autofluorescence in hemithyroidectomy on parathyroid gland identification and preservation in a low-volume institution with no experience in parathyroid surgery.
METHODS
Patients referred for hemithyroidectomy were randomized 1 : 1 to either autofluorescence-guided hemithyroidectomy (the near-infrared autofluorescence group) or conventional hemithyroidectomy (the control group). The primary outcome was parathyroid gland identification rate. Secondary outcomes were the rate of parathyroid gland autotransplantation and the rate of inadvertent parathyroid gland excision.
RESULTS
A total of 170 patients were randomized to either autofluorescence-guided hemithyroidectomy (84 patients) or conventional hemithyroidectomy (86 patients). In the near-infrared autofluorescence group, 81.0% of parathyroid glands were identified, compared with 57.0% in the control group (P < 0.001). Autofluorescence enabled parathyroid gland visualization before the naked eye in 46.3% of cases. Surgeons had lower confidence in the parathyroid gland identification process in the control group than in the near-infrared autofluorescence group (59.1% versus 87.5% respectively; P < 0.001). In the near-infrared autofluorescence group, the parathyroid gland autotransplantation rate was initially high, but declined over time. There was no difference in the rate of inadvertent parathyroid gland excision.
CONCLUSION
Autofluorescence guidance significantly improved the parathyroid gland identification rate in hemithyroidectomy in a low-volume institution with no experience in parathyroid surgery and provided an increase in surgical confidence. The pattern of parathyroid gland autotransplantation in autofluorescence-guided surgery indicates the presence of a learning curve.
REGISTRATION NUMBER
NCT05044351 (http://www.clinicaltrials.gov).
背景
最近的研究表明，没有甲状旁腺手术经验的低容量外科医生在甲状腺手术中导致甲状旁腺损伤的风险增加。本 RCT 的目的是评估在没有甲状旁腺手术经验的低容量机构中使用近红外荧光在半甲状腺切除术时对甲状旁腺识别和保留的影响。
方法
将转诊接受半甲状腺切除术的患者以 1:1 的比例随机分为近红外荧光引导半甲状腺切除术（近红外荧光组）或常规半甲状腺切除术（对照组）。主要结局是甲状旁腺识别率。次要结局是甲状旁腺自体移植率和意外甲状旁腺切除率。
结果
共有 170 名患者被随机分配至近红外荧光引导半甲状腺切除术（84 名患者）或常规半甲状腺切除术（86 名患者）。在近红外荧光组中，81.0%的甲状旁腺被识别，而对照组为 57.0%（P<0.001）。近红外荧光在 46.3%的病例中使甲状旁腺在肉眼观察之前可见。与近红外荧光组相比，对照组的外科医生在甲状旁腺识别过程中的信心较低（分别为 59.1%和 87.5%；P<0.001）。在近红外荧光组中，甲状旁腺自体移植率最初较高，但随着时间的推移逐渐下降。意外甲状旁腺切除率无差异。
结论
在没有甲状旁腺手术经验的低容量机构中，近红外荧光引导显著提高了半甲状腺切除术的甲状旁腺识别率，并增加了手术信心。近红外荧光引导手术中甲状旁腺自体移植的模式表明存在学习曲线。
登记号
NCT05044351（http://www.clinicaltrials.gov）。
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