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

The Use of Spinal Needles for Ultrasound-guided Fine Needle Aspiration From Thyroid Nodules - a Protocol for a Multicentre Randomised Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Thyroid Nodule
• Intervention / Treatment: Device: Spinal needle (25G); Device: Conventional fine needle (25G)

• Study Type: Interventional
• Enrollment (Anticipated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tobias Andersen, MD; Phone Number: 0045 28409266; Email: tobiasnicolaiandersen@gmail.com

Study Locations

• Denmark
  • Koege, Denmark, 4600
    • Recruiting
    • Zealand University Hospital
    • Contact: Tobias Andersen, MD; Phone Number: 28409266; Email: tvennervald@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Exclusion Criteria:

• Previous participation in the study.
• Language or other barriers not allowing adequate information.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spinal needle; Fine needle aspiration from thyroid nodules using af spinal needle.	Device: Spinal needle (25G); Fine needle aspiration from thyroid nodules using a 25G spinal needle.
Active Comparator: Conventional fine needle; Fine needle aspiration from thyroid nodules using af conventional fine needle, which is traditionally used.	Device: Conventional fine needle (25G); Fine needle aspiration from thyroid nodules using a conventional 25G fine needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic rate	The percentage of samples evaluated as "diagnostic" by the pathologist.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate	Complications, such as infections, bleedings or hematomas requiring treatment or admission, recurrent nerve injury and Horner's syndrome, will be recorded during the procedure. All patients are instructed to contact the department responsible for their management if they suspect complications. These will then be documented in the patient's medical record. At the end of the study period, the patient's medical records will be reviewed for admissions or contacts concerning complications.	Till 1 month after last inclusion. Corresponding to about 1 year
Pain assessment	Pain is assessed using the VAS (Visual Analog Scale) immediate after the procedure. The score is ranging from 0 to 10 with higher numbers indicating a more painful procedure.	About 2 years
Diagnostic accuracy	Cytology from FNAB is compared with histology in the subgroup of patients who undergo surgery during the course of the study	About 2 years

Collaborators and Investigators

• Sponsor: Preben Homøe
• Collaborators: Rigshospitalet, Denmark; Herlev Hospital
• Investigators: Principal Investigator: Tobias Andersen, MD, Zealand University Hospital, Køge, Denmark.

Publications and helpful links

General Publications

• Andersen TV, Bennedbaek FN, Pedersen J, Rosenorn MR, Kiss K, Lelkaitis G, Andersen L, Hegedus L, Lomholt AF, Hahn CH, Hvilsom GB, Homoe P, Todsen T. Spinal versus conventional fine needle for ultrasound-guided thyroid nodule biopsy: a protocol for a randomised clinical trial. Dan Med J. 2022 Jul 21;69(8):A03220165.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: March 7, 2021
• First Submitted That Met QC Criteria: May 7, 2021
• First Posted (Actual): May 10, 2021

Study Record Updates

• Last Update Posted (Actual): July 5, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Neoplasms; Thyroid Diseases; Thyroid Nodule
• Other Study ID Numbers: SJ-878

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data collected in this trial can be shared upon request from other researchers after publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No