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Comparative study of Ethanol injection, Radiofrequency Ablation, and Levothyroxine Therapy in Patients with Benign Thyroid Nodules: A Multicenter Randomized clinical Trial in Iran

Protocol summary

Study aim
Comparison of the effects of ethanol injection, radiofrequency ablation, levothyroxine therapy in the treatment of benign thyroid nodules based on nodule size changes in ultrasonography.
Design
Randomizes clinical trial with control group, parallel, single-blinded, on 91 patients through Block Randomization with blocks of 6.
Settings and conduct
In this multicenter study, after identifying the patient group, 31 patients underwent one-session radiofrequency ablation therapy, 30 patients underwent one session of 96% ethanol injection, and 30 patients underwent 6-month treatment with levothyroxine (standard dose 1.6-2.1 μg/kg/Per day), eventually this study will be single-blinded (data analyzer)
Participants/Inclusion and exclusion criteria
Inclusion criteria Normal thyroid test TSH, T4, T3, T3RU, Anti TPO History of pressure sign/nodule growth. Benign biopsy specimen. Normal blood calcitonin levels The patient has not received previous treatment for thyroid nodules Exclusion criteria: Nodules with malignant features Malignant or non-diagnostic pathology after biopsy under ultrasound guidance Pregnancy Abnormal thyroid function test or abnormal calcitonin
Intervention groups
Intervention medical treatment in form of suppression therapy with levothyroxine and intervention procedure with ethanol injection and radiofrequency ablation (RFA); levothyroxine treatment group is considered as control group and there is no placebo.
Main outcome variables
complications and efficacy of treatment with ethanol injection, radiofrequency ablation and levothyroxine therapy based on nodule size changes in ultrasound, gender, family history of thyroid cancer and changes in laboratory variables in the first, third and sixth months after treatment.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140712018457N6
Registration date: 2022-07-09, 1401/04/18
Registration timing: retrospective

Last update: 2022-07-09, 1401/04/18
Update count: 0
Registration date
2022-07-09, 1401/04/18
Registrant information
Name
Hossein Ghanaati
Name of organization / entity
Advanced Diagnostic and Interventional Radiology Research Center (ADIR), Tehran University of Medica
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1516
Email address
ghenaati@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-07, 1400/07/15
Expected recruitment end date
2022-05-05, 1401/02/15
Actual recruitment start date
2021-10-07, 1400/07/15
Actual recruitment end date
2022-05-21, 1401/02/31
Trial completion date
empty
Scientific title
Comparative study of Ethanol injection, Radiofrequency Ablation, and Levothyroxine Therapy in Patients with Benign Thyroid Nodules: A Multicenter Randomized clinical Trial in Iran
Public title
Comparative study of the different treatment methods in size reduction of the benign thyroid nodules
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Normal thyroid test including TSH, T۴, T۳, T۳RU, Anti TPO The nodule has grown or the patient reports pressure sign FNA biopsy specimen or core needle biopsy under ultrasound guidance is benign. Normal blood calcitonin level The patient has not received previous treatment for thyroid nodules
Exclusion criteria:
Malignant sonographic features of thyroid nodules Malignant or non-diagnostic lesions in pathology results Pregnancy Abnormal thyroid function tests or abnormal calcitonin
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 90
Actual sample size reached: 91
Randomization (investigator's opinion)
Randomized
Randomization description
After getting familiar with the study design and obtaining the informed consent form, patients enter the intervention group (ethanol or radiofrequency therapy) or medical treatment (levothyroxine) group using block randomization method with block of 6.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, each group is given a specific name (such as A, B, and C) so that the nature of the group's treatment is unknown to the person who follows up and evaluates the results within 6 months (indeed the evaluator is blinded).
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Imam Khomeini Hospital Medical Ethics Committee
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2021-10-06, 1400/07/14
Ethics committee reference number
IR.TUMS.IKHC.REC.1400.248

Health conditions studied

1

Description of health condition studied
Benign thyroid nodule
ICD-10 code
E04.1
ICD-10 code description
Nontoxic single thyroid nodule

Primary outcomes

1

Description
Size of thyroid nodule
Timepoint
one, three and six month following related treatment.
Method of measurement
Measurement of thyroid nodules size using ultrasound based on millimeters

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients treated with radiofrequency ablation and ethanol injection
Category
Treatment - Other

2

Description
Control group: patients treated with Levothyroxine
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital complex
Full name of responsible person
Hossein Ghanaati
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1579
Email
ghanaati@yahoo.com

2

Recruitment center
Name of recruitment center
Tehran medical imaging center
Full name of responsible person
Hossein Ghanaati
Street address
No 27, W Mir hadi Alley, Jooybar St, Fatei Sq
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8897 1179
Email
Tehranmedicalimaging@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Ghanaati
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 81631
Email
ghanaati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
1
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
Tehran University of Medical Sciences
Full name of responsible person
Mahsa Alborzi
Position
GP, research assistant
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1579
Email
mahsaalborzi94@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahsa Alborzi Avanaki
Position
GP, research assistant
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1579
Email
mahsaalborzi94@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Ghanaati
Position
Professor of radiology
Latest degree
Subspecialist
Other areas of specialty/work
Radiology
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1579
Email
ghanaati@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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