Evidence map›Paper›PMID 40743258›Full record

Trial reportPloS one2025

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

Kasper Daugaard Larsen, Gitte Bjørn Hvilsom, Tobias Vennervald Andersen, Preben Homøe, Finn Noe Bennedbæk, Jens Pedersen, Lena Bjergved Sigurd, Jens Jessen Warm, Katalin Kiss, Giedrius Lelkaitis and 8 more

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Development and validation of a theoretical test for ultrasound-guided biopsy competence in the head and neck.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2026
    Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Kasper Daugaard LarsenDepartment of Otorhinolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet - Copenhagen University Hospital, Copenhagen, Denmark.ORCID https://orcid.org/0000-0002-5386-4051
Gitte Bjørn HvilsomDepartment of Otorhinolaryngology, Head and Neck Surgery, Zealand University Hospital, Køge, Denmark.ORCID https://orcid.org/0000-0001-9239-3208
Tobias Vennervald AndersenDepartment of Otorhinolaryngology, Head and Neck Surgery, Zealand University Hospital, Køge, Denmark.
Preben HomøeDepartment of Otorhinolaryngology, Head and Neck Surgery, Zealand University Hospital, Køge, Denmark.
Finn Noe BennedbækDepartment of Endocrinology and Metabolism, Herlev and Gentofte Hospital, Herlev, Denmark.
Jens PedersenInstitute of Clinical Medicine, Faculty of Health Sciences, Copenhagen University, Copenhagen, Denmark.
Lena Bjergved SigurdInstitute of Clinical Medicine, Faculty of Health Sciences, Copenhagen University, Copenhagen, Denmark.
Jens Jessen WarmDepartment of Otorhinolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet - Copenhagen University Hospital, Copenhagen, Denmark.
Katalin KissDepartment of Pathology, Rigshospitalet - Copenhagen University Hospital, Copenhagen, Denmark.
Giedrius LelkaitisDepartment of Pathology, Rigshospitalet - Copenhagen University Hospital, Copenhagen, Denmark.
Luise AndersenDepartment of Pathology, Rigshospitalet - Copenhagen University Hospital, Copenhagen, Denmark.
Marie Røsland RosenørnDepartment of Pathology, Zealand University Hospital, Roskilde, Denmark.
Laszlo HegedüsDepartment of Endocrinology, Odense University Hospital, University of Southern Denmark, Odense, Denmark.
Annette Kjær ErsbøllNational Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark.
Anne Fog LomholtDepartment of Otorhinolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet - Copenhagen University Hospital, Copenhagen, Denmark.
Mikkel KaltoftDepartment of Otorhinolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet - Copenhagen University Hospital, Copenhagen, Denmark.ORCID https://orcid.org/0009-0000-1900-3445
Christoffer Holst HahnDepartment of Otorhinolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet - Copenhagen University Hospital, Copenhagen, Denmark.
Tobias TodsenDepartment of Otorhinolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet - Copenhagen University Hospital, Copenhagen, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveUltrasound-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.

methodsBetween 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.

resultsA 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).

conclusionsNo 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.

Indexed as

NeedlesThyroid NoduleAdultAgedAged, 80 and overBiopsy, Fine-NeedleFemaleHumansMaleMiddle AgedYoung Adult

Identifiers

PMID40743258
PMCPMC12312885

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.