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

Sponsor

Preben Homøe (Other)

Overall Status

Recruiting

CT.gov ID

NCT04879355

Collaborator

Herlev Hospital (Other), Rigshospitalet, Denmark (Other)

350

Enrollment

Location

Arms

Anticipated Duration (Months)

14.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Nodule	Device: Spinal needle (25G) Device: Conventional fine needle (25G)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

350 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Diagnostic rate [1 year]
The percentage of samples evaluated as "diagnostic" by the pathologist.

Secondary Outcome Measures

Complication rate [Till 1 month after last inclusion. Corresponding to about 1 year]
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.
Pain assessment [About 2 years]
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.
Diagnostic accuracy [About 2 years]
Cytology from FNAB is compared with histology in the subgroup of patients who undergo surgery during the course of the study

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

≥18 years of age.
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.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zealand University Hospital	Koege		Denmark	4600

Sponsors and Collaborators

Preben Homøe
Herlev Hospital
Rigshospitalet, Denmark

Investigators

Principal Investigator: Tobias Andersen, MD, Zealand University Hospital, Køge, Denmark.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Preben Homøe, Professor, Zealand University Hospital

ClinicalTrials.gov Identifier:

NCT04879355

Other Study ID Numbers:

SJ-878

First Posted:

May 10, 2021

Last Update Posted:

Jul 5, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Thyroid Nodule

Thyroid Diseases

Study Results

No Results Posted as of Jul 5, 2022