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Effectiveness of radiofrequency ablation therapy with ultrasound guidance in thyroid nodules

Protocol summary

Study aim
Determining the effectiveness of ultrasound-guided radiofrequency ablation therapy in the treatment of thyroid nodules
Design
The current study is a non-randomized clinical trial. It should be noted that there is no randomization, blinding, or control group in this study.
Settings and conduct
In this study, patients in the intervention group who visited the office of Dr. Talaei Zadeh and Dr. Motamedfar during the research registration period were entered in the study based on inclusion criteria and exclusion criteria. Patients are then referred to the office of Dr. Motamed Far, an interventional radiologist, for an ultrasound-guided RFA procedure, and this procedure is performed on them; then, 3 months after the first RFA session for their fallopian tubes, they undergo a thyroid ultrasound.
Participants/Inclusion and exclusion criteria
Patients must be over 18 years of age. The diagnosis of autonomous nodule or benign thyroid nodule must be definitive and documented. Patients with residual thyroid after thyroid cancer surgery. Patients with metastatic lymph nodes after LND surgery for thyroid cancer. Patients with benign thyroid nodules less than 20 mm without clinical symptoms. Patients with a benign thyroid nodule greater than 20 mm with clinical symptoms. Patients with autonomous thyroid nodules less than 20 ml.
Intervention groups
In current study, the intervention will be performed on patients with benign nodules, autonomous thyroid nodules, thyroid remnants remaining after thyroid cancer surgery, and metastatic lymph nodes remaining after thyroid cancer lymph node dissection surgery based on inclusion and exclusion criteria.
Main outcome variables
The thyroid nodule volume reduction rate (VRR) is the result of dividing the difference between the pre-procedure and post-procedure volume of the thyroid nodule by the pre-procedure volume multiplied by 100.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251024067738N1
Registration date: 2025-11-04, 1404/08/13
Registration timing: registered_while_recruiting

Last update: 2025-11-04, 1404/08/13
Update count: 0
Registration date
2025-11-04, 1404/08/13
Registrant information
Name
Nima Farhadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 937 057 7224
Email address
farhadi.ni@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-03, 1404/08/12
Expected recruitment end date
2026-02-01, 1404/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of radiofrequency ablation therapy with ultrasound guidance in thyroid nodules
Public title
ًRadiofrequency ablation in thyroid nodules
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a definitive and documented diagnosis of autonomous nodule or benign thyroid nodule. Patients must be over 18 years of age. Patients with residual thyroid after thyroid cancer surgery. Patients with metastatic lymph nodes after lymph node dissection surgery for thyroid cancer. Patients with benign thyroid nodules less than 20 mm without clinical symptoms. Patients with a benign thyroid nodule greater than 20 mm with clinical symptoms. Patients with autonomous thyroid nodules less than 20 ml.
Exclusion criteria:
Patients who do not consent to participate in the research. Patients with known cases of dementia or psychiatric cognitive disorders. Patients under 18 years of age. Patients in whom the diagnosis of autonomous nodule or benign thyroid nodule is not definitive and documented. Patients with autonomous nodules with a volume greater than 20 ml.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics commitee, Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz, Golestan Boulevard, Ahvaz Jundishapur University of Medical Sciences, secretary for Research, Research Ethics commitee
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2025-10-22, 1404/07/30
Ethics committee reference number
IR.AJUMS.REC.1404.370

Health conditions studied

1

Description of health condition studied
Benign thyroid nodules - Autonomous thyroid nodule - Residual thyroid after thyroid cancer surgery - Residual metastatic lymph nodes after lymph node dissection for thyroid cancer.
ICD-10 code
E04.1
ICD-10 code description
Nontoxic single thyroid nodule

Primary outcomes

1

Description
Thyroid nodule volume reduction rate: It is created by dividing the difference between the pre- and post-thyroid nodule volume by the pre-thyroid nodule volume multiplied by 100.
Timepoint
The volume of the thyroid nodule or lymph node is examined first and 3 and 6 months after the procedure.
Method of measurement
The size of the thyroid nodule or lymph node is determined by ultrasonography of the thyroid or neck.

Secondary outcomes

1

Description
Minor and major complications resulting from ultrasound-guided radio frequency ablation procedure
Timepoint
Beginning of study, 3 and 6 months after the procedure
Method of measurement
History, physical examination, thyroid and neck ultrasound, and thyroid function test

Intervention groups

1

Description
Intervention group: Patients with benign nodules, autonomous thyroid nodules, thyroid remnants remaining after thyroid cancer surgery, and metastatic lymph nodes remaining after thyroid cancer lymph node dissection surgery
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Ahvaz
Full name of responsible person
Abdulhassan Talaizadeh
Street address
Ahvaz, Shahid Azadegan Street, Imam Khomeini Hospital, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3292 3985
Email
hemam@ajums.ac.ir
Web page address
https://himam.ajums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Abdulhasan Talaeizadeh
Street address
Jundishapour University of Medical Sciences, Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 4115
Email
info@ajums.ac.ir
Web page address
https://ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Abdulhasan Talaeizadeh
Position
Professor of Cancer Surgery
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Ahvaz, Shahid Azadegan Street, Imam Khomeini Hospital, General Surgery Department
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 9101 0801
Email
Ahtalaiezadeh@yahoo.com
Web page address
https://professortalaeizadeh.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Abdulhasan Talaeizadeh
Position
Professor of cancer surgery
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Ahvaz, Azadegan Street, Imam Khomeini Educational-Therapeutic Center - Surgery Department
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 2818
Email
Ahtalaiezadeh@yahoo.com
Web page address
http://professortalaiezadeh.ir/

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Abdulhasan Talaeizadeh
Position
Professor of Cancer Surgery
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Ahvaz, Shahid Azadegan Street, Imam Khomeini Hospital, General Surgery Department
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 9101 0801
Email
Ahtalaiezadeh@yahoo.com
Web page address
https://himam.ajums.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the human nature of the current study and information about the demographics, course of treatment, and clinical findings of the patients participating in this study, based on the principles of medical confidentiality and the principles of ethics in research, there is no desire to publish the data file after the end of the clinical trial.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Due to the human nature of the current study and information about the demographics, course of treatment, and clinical findings of the patients participating in this study, based on the principles of medical confidentiality and the principles of ethics in research, there is no desire to publish the data file after the end of the clinical trial.
When the data will become available and for how long
Due to the human nature of the current study and information about the demographics, course of treatment, and clinical findings of the patients participating in this study, based on the principles of medical confidentiality and the principles of ethics in research, there is no desire to publish the data file after the end of the clinical trial.
To whom data/document is available
Only the reviewers of the journal to which the article resulting from this research project is submitted will be allowed to use the data from this clinical trial after going through the process of obtaining permission from the Research Ethics Committee and the Vice President for Research of Ahvaz University of Medical Sciences.
Under which criteria data/document could be used
The use of data from this research for purposes other than publishing the article with the coordination of the corresponding author is not permitted.
From where data/document is obtainable
To obtain data, you can contact the corresponding author for the current research.
What processes are involved for a request to access data/document
Sending an email to the corresponding author
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