Journal Article

Spinal needles versus conventional needles for fine-needle aspiration biopsy of thyroid nodules—A multicenter randomized controlled trial

Pedersen, Jens, Hvilsom, Gitte Bjørn, Hegedüs, Laszlo, Andersen, Tobias Vennervald, Rosenørn, Marie Røsland, Todsen, Tobias, Kiss, Katalin, Larsen, Kasper Daugaard, Bennedbæk, Finn Noe, Homøe, Preben, Andersen, Luise, Kaltoft, Mikkel, Hahn, Christoffer Holst, Ersbøll, Annette Kjær, Sigurd, Lena Bjergved, Lelkaitis, Giedrius, Warm, Jens Jessen, Lomholt, Anne Fog

2025

Overview

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. 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. 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). 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.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Ablation / Adequacy / Adult / Aged / Aged, 80 and over / Biology and Life Sciences / Biopsy / Biopsy, Fine-Needle - adverse effects / Biopsy, Fine-Needle - instrumentation / Biopsy, Fine-Needle - methods / Biopsy, Needle / Cellular biology / Clinical trials / Comparative analysis / Consent / Cytology / Departments / Female / Hematoma / Histology / Hospital costs / Humans / Male / Medicine and Health Sciences / Methods / Middle Aged / Needles / Nodules / Otolaryngology / Pain / Pain sensitivity / Patients / People and Places / Physicians / Regression analysis / Research and Analysis Methods / Sample size / Statistical analysis / Surgery / Thyroid / Thyroid gland / Thyroid Nodule - diagnosis / Thyroid Nodule - pathology / Ultrasonic imaging / Young Adult