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

Primary Purpose

Thyroid Nodule

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Spinal needle (25G)
Conventional fine needle (25G)
Sponsored by
Preben Homøe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thyroid Nodule

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Zealand University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Spinal needle

Conventional fine needle

Arm Description

Fine needle aspiration from thyroid nodules using af spinal needle.

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

Outcomes

Primary Outcome Measures

Diagnostic rate
The percentage of samples evaluated as "diagnostic" by the pathologist.

Secondary Outcome Measures

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.
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.
Diagnostic accuracy
Cytology from FNAB is compared with histology in the subgroup of patients who undergo surgery during the course of the study

Full Information

First Posted
March 7, 2021
Last Updated
June 29, 2022
Sponsor
Preben Homøe
Collaborators
Herlev Hospital, Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT04879355
Brief Title
Spinal Needles in Ultrasound-guided Fine Needle Aspirations From Thyroid Nodules
Official Title
The Use of Spinal Needles for Ultrasound-guided Fine Needle Aspiration From Thyroid Nodules - a Protocol for a Multicentre Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Preben Homøe
Collaborators
Herlev Hospital, Rigshospitalet, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodule

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes Assessor
Masking Description
The patients and the pathologists are blinded to the intervention, while the clinicians performing the FNAs are not.
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spinal needle
Arm Type
Experimental
Arm Description
Fine needle aspiration from thyroid nodules using af spinal needle.
Arm Title
Conventional fine needle
Arm Type
Active Comparator
Arm Description
Fine needle aspiration from thyroid nodules using af conventional fine needle, which is traditionally used.
Intervention Type
Device
Intervention Name(s)
Spinal needle (25G)
Intervention Description
Fine needle aspiration from thyroid nodules using a 25G spinal needle.
Intervention Type
Device
Intervention Name(s)
Conventional fine needle (25G)
Intervention Description
Fine needle aspiration from thyroid nodules using a conventional 25G fine needle
Primary Outcome Measure Information:
Title
Diagnostic rate
Description
The percentage of samples evaluated as "diagnostic" by the pathologist.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Complication rate
Description
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.
Time Frame
Till 1 month after last inclusion. Corresponding to about 1 year
Title
Pain assessment
Description
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.
Time Frame
About 2 years
Title
Diagnostic accuracy
Description
Cytology from FNAB is compared with histology in the subgroup of patients who undergo surgery during the course of the study
Time Frame
About 2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tobias Andersen, MD
Phone
28409266
Ext
0045
Email
tobiasnicolaiandersen@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Andersen, MD
Organizational Affiliation
Zealand University Hospital, Køge, Denmark.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zealand University Hospital
City
Koege
ZIP/Postal Code
4600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias Andersen, MD
Phone
28409266
Email
tvennervald@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data collected in this trial can be shared upon request from other researchers after publication.
Citations:
PubMed Identifier
35959834
Citation
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.
Results Reference
derived

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

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