To determine the effect of percutaneous ethanol injection in the treatment of benign cystic and mixed thyroid nodules based on nodules size changes in ultrasonography
Design
Randomized clinical trial with control group, parallel, on 52 patients through Block Randomization with blocks of 4
Settings and conduct
In this study, after identifying the patient group including 52 patients with benign cystic and predominantly cystic thyroid nodules, 26 patients in the intervention group will be treated with percutaneous ethanol injection under ultrasound guidance. Patients in the control group will not receive any intervention including percutaneous ethanol injection or surgery, and the size of the nodules will be evaluated before the intervention and 6 months later.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with benign cystic and predominantly cystic thyroid nodules
Patients with a minimum age of 18 years
Exclusion criteria:
Patients confirmed with or suspected of thyroid cancer
Patients younger than 18 years old
Patients with a history of hypersensitivity reaction to methanol
Pregnant women
Patients suspected of Covid-19 infection
Intervention groups
Intervention group: Patients treated with percutaneous ethanol injection
Control group: Patients did not receive any intervention
Main outcome variables
Determining thyroid nodules size changes based on ultrasound at the beginning of the study (before the start of the intervention) and 6 months after the relevant treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240718062461N1
Registration date:2024-08-04, 1403/05/14
Registration timing:retrospective
Last update:2024-08-04, 1403/05/14
Update count:0
Registration date
2024-08-04, 1403/05/14
Registrant information
Name
Mohammad Sakhaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3323 0110
Email address
yaghobsakhaei@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-04, 1399/03/15
Expected recruitment end date
2020-12-15, 1399/09/25
Actual recruitment start date
2020-06-04, 1399/03/15
Actual recruitment end date
2020-12-15, 1399/09/25
Trial completion date
2021-06-16, 1400/03/26
Scientific title
Efficacy of percutaneous ethanol injection in benign cystic and mixed thyroid nodules: a randomized clinical trial
Public title
Percutaneous ethanol injection in benign thyroid nodules
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with benign cystic and predominantly cystic thyroid nodules
Patients with a minimum age of 18 years
Exclusion criteria:
Patients confirmed or suspected of thyroid cancer
Patients suspected of Covid-19 infection
Patients with a history of hypersensitivity reaction to methanol
Pregnant women
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Actual sample size reached:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Restricted randomization
block randomization
Choose the size of the blocks randomly
Random blocks of 2, 4 and 6 people
Using Sequentially numbered, sealed, opaque envelopes to hide random allocation
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committee of Islamic Azad University Sari Branch
Street address
Farahabad Road
City
Sari
Province
Mazandaran
Postal code
48164-194
Approval date
2020-05-03, 1399/02/14
Ethics committee reference number
IR.IAU.SARI.REC.1399.030
Health conditions studied
1
Description of health condition studied
benign thyroid nodules
ICD-10 code
E04.1
ICD-10 code description
Nontoxic single thyroid nodule
Primary outcomes
1
Description
Thyroid nodules size changes in ultrasonography
Timepoint
Measurement of the thyroid nodules size at baseline and at sixth months following treatment
Method of measurement
Measurement of thyroid nodules size using ultrasound based on ellipsoid formula
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients treated with ablation therapy technique including subcutaneous injection of 99% ethanol will be guided by ultrasound. The procedure will be performed by a radiologist with several years of experience in the field of subcutaneous injections in thyroid nodules with a precise radiological technique. First, the area is cleaned with 50% alcohol and then the liquid contents of the nodule are aspirated. The volume of injected ethanol is calculated as 50% of the primary thyroid nodule volume, which is slowly injected with a needle in small pulses by moving up-down and sideways.
Category
Treatment - Other
2
Description
Control group: Patients did not receive any intervention
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sari Imam Khomeini Hospital
Full name of responsible person
Sayed Mohammad Sakhaei
Street address
Razi Sreet
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3335 0670
Email
Yaghobsakhaei@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sayed Mohammad Sakhaei
Street address
Farahabad Road
City
Sari
Province
Mazandaran
Postal code
۱۹۴-۴۸۱۶۴
Phone
+98 11 3303 2891
Email
Yaghobsakhaei@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Mazandaran University of Medical Sciences
Full name of responsible person
Ghazal Mohseni
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Moallem Square, Deputy of research and technology, Student Research Committee office
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3448 4864
Email
mohseni.ghazal@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ghazal Mohseni
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Moallem Square, Deputy of research and technology, Student Research Committee office
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3448 4864
Email
mohseni.ghazal@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Sayed Mohammad Sakhaei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Radiology
Street address
Razi Street, Department of Radiology and Nuclear Medicine, School of Medicine, Sari Imam Khomeini Hospital
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3323 0110
Email
Yaghobsakhaei@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available