TY - JOUR
T1 - Spinal versus conventional fine needle for ultrasound-guided thyroid nodule biopsy
T2 - a protocol for a randomised clinical trial
AU - Andersen, Tobias Vennervald
AU - Bennedbæk, Finn Noe
AU - Pedersen, Jens
AU - Rosenørn, Marie Røsland
AU - Kiss, Katalin
AU - Lelkaitis, Giedrius
AU - Andersen, Luise
AU - Hegedüs, Laszlo
AU - Lomholt, Anne Fog
AU - Hahn, Christoffer Holst
AU - Hvilsom, Gitte Bjørn
AU - Homøe, Preben
AU - Todsen, Tobias
N1 - Articles published in the DMJ are “open access”. This means that the articles are distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits any non-commercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited.
PY - 2022/7/21
Y1 - 2022/7/21
N2 - INTRODUCTION: Thyroid nodules are very common and constitute an increasing clinical challenge since improved imaging capabilities and utilisation have led to a higher number of incidental findings. Ultrasound-guided fine-needle aspiration biopsy (FNAB) is the standard diagnostic tool in the work-up of thyroid nodules suspected of malignancy. Non-diagnostic results remain common and require repeated FNAB, leading to increased costs and delayed treatment of thyroid diseases, including treatment of thyroid cancer. If cytological diagnoses cannot be achieved, surgery may be warranted, which may potentially lead to overtreatment. Optimisation of the FNAB procedure is therefore essential. Spinal needles with a stylet have been found to lead to fewer non-diagnostic results, but studies on the subject are few.METHODS: This is a multicentre, two-arm, randomised clinical trial. Adults with thyroid nodules suspected of malignancy will be included consecutively. A total of 350 patients will be assigned randomly 1:1 to have a FNAB with either a spinal (25G) or a conventional (25G) needle. The primary outcome is the rate of diagnostic cytological samples according to the Bethesda system. Secondary outcomes are patient-experienced pain, complication rate and sensitivity and specificity.CONCLUSIONS: This trial will explore whether FNAB from thyroid nodules employing spinal needles compared with conventional fine needles improves diagnostic results, thereby providing evidence-based recommendations for a future choice of the FNAB needle. Secondary outcomes are patient-experienced pain, complication rate and sensitivity and specificity.FUNDING: This trial received funding from Erik and Susanna Olesens Fond. The funding source had no influence on trial design, data collection, analysis or publication.CLINICALTRIALS: gov Identifier: NCT04879355. Registration date: 07032021; version: 29062022.
AB - INTRODUCTION: Thyroid nodules are very common and constitute an increasing clinical challenge since improved imaging capabilities and utilisation have led to a higher number of incidental findings. Ultrasound-guided fine-needle aspiration biopsy (FNAB) is the standard diagnostic tool in the work-up of thyroid nodules suspected of malignancy. Non-diagnostic results remain common and require repeated FNAB, leading to increased costs and delayed treatment of thyroid diseases, including treatment of thyroid cancer. If cytological diagnoses cannot be achieved, surgery may be warranted, which may potentially lead to overtreatment. Optimisation of the FNAB procedure is therefore essential. Spinal needles with a stylet have been found to lead to fewer non-diagnostic results, but studies on the subject are few.METHODS: This is a multicentre, two-arm, randomised clinical trial. Adults with thyroid nodules suspected of malignancy will be included consecutively. A total of 350 patients will be assigned randomly 1:1 to have a FNAB with either a spinal (25G) or a conventional (25G) needle. The primary outcome is the rate of diagnostic cytological samples according to the Bethesda system. Secondary outcomes are patient-experienced pain, complication rate and sensitivity and specificity.CONCLUSIONS: This trial will explore whether FNAB from thyroid nodules employing spinal needles compared with conventional fine needles improves diagnostic results, thereby providing evidence-based recommendations for a future choice of the FNAB needle. Secondary outcomes are patient-experienced pain, complication rate and sensitivity and specificity.FUNDING: This trial received funding from Erik and Susanna Olesens Fond. The funding source had no influence on trial design, data collection, analysis or publication.CLINICALTRIALS: gov Identifier: NCT04879355. Registration date: 07032021; version: 29062022.
KW - Adult
KW - Biopsy, Fine-Needle/methods
KW - Humans
KW - Multicenter Studies as Topic
KW - Pain
KW - Randomized Controlled Trials as Topic
KW - Retrospective Studies
KW - Sensitivity and Specificity
KW - Thyroid Neoplasms/diagnosis
KW - Thyroid Nodule/diagnostic imaging
KW - Ultrasonography, Interventional
UR - https://ugeskriftet.dk/dmj/spinal-versus-conventional-fine-needle-ultrasound-guided-thyroid-nodule-biopsy-protocol-randomised
M3 - Journal article
C2 - 35959834
SN - 1603-9629
VL - 69
JO - Danish Medical Journal
JF - Danish Medical Journal
IS - 8
M1 - A03220165
ER -