Spinal Needles in Ultrasound-guided Fine Needle Aspirations From Thyroid Nodules

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-11-01

Brief Summary

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This is a multicentre, two-arm, randomised and controlled trial. Adults with thyroid nodules suspected of malignancy are to be included consecutively. A total of 350 patients are randomly assigned 1:1 to have FNA with 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 diagnostic accuracy, patient's experienced pain and complication rates.

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Detailed Description

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Conditions

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Thyroid Nodule

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Eligible patients are randomised at a 1:1-ratio to one of two parallel groups, and all patients are included in the analysis on an intention-to-treat basis.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The patients and the pathologists are blinded to the intervention, while the clinicians performing the FNAs are not.

Study Groups

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Spinal needle

Fine needle aspiration from thyroid nodules using af spinal needle.

Group Type EXPERIMENTAL

Spinal needle (25G)

Intervention Type DEVICE

Fine needle aspiration from thyroid nodules using a 25G spinal needle.

Conventional fine needle

Fine needle aspiration from thyroid nodules using af conventional fine needle, which is traditionally used.

Group Type ACTIVE_COMPARATOR

Conventional fine needle (25G)

Intervention Type DEVICE

Fine needle aspiration from thyroid nodules using a conventional 25G fine needle

Interventions

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Spinal needle (25G)

Fine needle aspiration from thyroid nodules using a 25G spinal needle.

Intervention Type DEVICE

Conventional fine needle (25G)

Fine needle aspiration from thyroid nodules using a conventional 25G fine needle

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. ≥18 years of age.
2. Patients referred for evaluation of a cold nodule on thyroid scintigraphy and with EU-TIRADS score of 3 or higher.

* Score 3 and \> 20 mm in size.
* Score 4 and \>15 mm in size.
* Score 5 and \>10 mm in size.
3. Clinical suspicion of thyroid cancer:

* PET-positive thyroid tumor.
* Thyroid tumor and palsy of the recurrent laryngeal nerve.
* Rapidly growing thyroid tumor.
* Hard and/or immobile thyroid tumor.
* Tumor in the thyroid with suspicious lymph nodes.