PloS one · 2025
Spinal needles versus conventional needles for fine-needle aspiration biopsy of thyroid nodules-A multicenter randomized controlled trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
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Larsen Kasper Daugaard, Hvilsom Gitte Bjørn, Andersen Tobias Vennervald, Homøe Preben, Bennedbæk Finn Noe, Pedersen Jens, Sigurd Lena Bjergved, Warm Jens Jessen, Kiss Katalin, Lelkaitis Giedrius, Andersen Luise, Rosenørn Marie Røsland, Hegedüs Laszlo, Ersbøll Annette Kjær, Lomholt Anne Fog, Kaltoft Mikkel, Hahn Christoffer Holst, Todsen Tobias
Аннотация
OBJECTIVE: Ultrasound-guided fine-needle aspiration biopsy (FNAB) is essential for evaluating thyroid nodules but often yields inadequate samples, leading to repeated procedures, increased discomfort, and higher costs. Previous non-randomized studies found promising results of spinal needles to improve diagnostic adequacy. Therefore, we conducted a multicenter randomized controlled trial to validate these findings.
METHODS: Between July 1st, 2021, and April 13th, 2023, patients with suspicious thyroid nodules were randomized to receive FNAB with either a 25G spinal needle or conventional needle. The primary outcome was the rate of adequate diagnostic cytology. Secondary outcomes included procedure-related pain, sensitivity and specificity of FNAB, and adverse events.
RESULTS: A total of 359 patients (75.6% female), with a mean age of 59.7 years (range 23-94) were randomized. The rate of adequate diagnostic FNAB was 86.2% (156/181) for the spinal group compared to 84.8% (151/178) for the control group (OR 1.01; 95% CI: 0.95-1.08). The mean pain scale score was 4.0 (SD = 1.8) in the spinal group and 3.9 (SD = 2.0) in the control group (p = 0.40). No complications were observed in either group. We found a significantly better cytological adequacy rate of FNABs performed by physicians with more than four years of experience in the procedure (OR=1.07; 95% CI, 1.01-1.14).
CONCLUSIONS: No significant improvement was found using spinal needles with a stylet compared to conventional needles. Given the significantly higher cost of spinal needles and comparable diagnostic outcomes, their routine use for thyroid FNAB is not recommended.
METHODS: Between July 1st, 2021, and April 13th, 2023, patients with suspicious thyroid nodules were randomized to receive FNAB with either a 25G spinal needle or conventional needle. The primary outcome was the rate of adequate diagnostic cytology. Secondary outcomes included procedure-related pain, sensitivity and specificity of FNAB, and adverse events.
RESULTS: A total of 359 patients (75.6% female), with a mean age of 59.7 years (range 23-94) were randomized. The rate of adequate diagnostic FNAB was 86.2% (156/181) for the spinal group compared to 84.8% (151/178) for the control group (OR 1.01; 95% CI: 0.95-1.08). The mean pain scale score was 4.0 (SD = 1.8) in the spinal group and 3.9 (SD = 2.0) in the control group (p = 0.40). No complications were observed in either group. We found a significantly better cytological adequacy rate of FNABs performed by physicians with more than four years of experience in the procedure (OR=1.07; 95% CI, 1.01-1.14).
CONCLUSIONS: No significant improvement was found using spinal needles with a stylet compared to conventional needles. Given the significantly higher cost of spinal needles and comparable diagnostic outcomes, their routine use for thyroid FNAB is not recommended.