Thyroid NoduleNCT01778400
RFA (Radiofrequency Ablation) Versus EA (Ethanol Ablation) for Predominantly Cystic Thyroid Nodules
A study testing radiofrequency ablation and Ethanol ablation in people with Thyroid Nodule, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Ultrasound-guided ethanol ablation is an effective treatment modality for patients with cystic thyroid nodules (cystic portion > 90%); however it is less effective in predominantly cystic thyroid nodules (90% > cystic portions > 50%). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- radiofrequency ablation and Ethanol ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with predominantly cystic thyroid nodules (90% > cystic portion > 50%)
- reports of pressure symptoms or cosmetic problems
- cytologic confirmation of benignancy in at least two, separate US-guided, fine-needle aspiration cytology or core needle biopsy for cystic fluid and/or a mural, solid component
- serum levels of thyroid hormone, thyrotropin, and calcitonin within normal limits.
Who cannot join
- nodules showing malignant features, i.e. taller than wide, spiculated margin, markedly hypoechoic, micro- or macrocalcifications, on US
- lack of informed consent
- less than 20 years old
- pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Session Treatment of RFA Versus EA for Predominantly Cystic Thyroid Nodules: A Randomized Controlled Trial
Ultrasound-guided ethanol ablation is an effective treatment modality for patients with cystic thyroid nodules (cystic portion > 90%); however it is less effective in predominantly cystic thyroid nodules (90% > cystic portions > 50%). The volume reduction after EA has been reported 64% - 69.8% for predominantly cystic thyroid nodules. EA is insufficient for 26% (27/103) of patients with predominantly cystic thyroid nodules. Radiofrequency ablation to patients with incompletely resolved clinical problems after EA and the mean volume reduction ratio was 92% at 6-month follow-up. It is well known that RF ablation is effective in both predominantly cystic and solid thyroid nodules. Although RF ablation has effectively treated the patients who were unsatisfactory after EA, to the best of our knowledge, no study to date has compared these two ablation techniques. Therefore investigators performed a prospective randomized study to compare single-session RF ablation and EA for treating predominantly cystic thyroid nodules.
Read the detailed description
Ablation Procedures Both RF ablation and EA will perform with each patient in the supine position and with mild neck extension. Before the treatment, investigators will measure the three orthogonal diameters of each nodule, i.e, the largest diameter and two other, mutually perpendicular diameters, and the volume of each nodule was calculated using the equation V = π abc/6, where V is the volume, a is the largest diameter, and b and c are the other two diameters. Investigators will use 2% lidocaine at skin puncture site. The skin will be punctured, and target nodules will be approached using the trans-isthmic approach method in which the RF ablation electrode or EA needle is inserted into the short axis of the nodule from the isthmus to the targeting nodule. This technical approach has several advantages. It can prevent a change in the position of the needle or electrode when the patient is swallowing or talking during the ablation and can also prevent fluid leakage, i.e. injected ethanol or ablated, hot fluid of the cystic portion of thyroid nodules, to areas outside the thyroid gland. This approach also allows clear, continuous US monitoring of the relationship of the nodule, the needle or electrode tip, and the expected location of the recurrent laryngeal nerve, thus minimizing the risks of injury to that nerve and/or the esophagus.
Radiofrequency Ablation All patients will be required to fast for at least six hours before each procedure. Before starting the RF ablation, investigators will aspirate the internal fluid as much as possible .
Moving shot technique for thyroid RF ablation has been proposed. In treatment of the liver, the electrode is fixed during ablation. Because the thyroid is a relatively small organ compared with the liver, prolonged fixation of the electrode is dangerous. Investigators therefore divide thyroid nodules into multiple conceptual ablation units, and perform RF ablation unit by unit by moving the electrode tip. These conceptual ablation units are smaller in the periphery of the nodule and in the portion of the nodule adjacent to the critical structures of the neck; however the units are larger in the central safe portion. Initially, the electrode tip will be positioned in the deepest, most remote imaginary unit of the nodule to enable easy monitoring of the electrode tip without the disturbance caused by microbubbles. The electrode moves within the thyroid mass by tilting it upward or downward. When ablation in the peripheral unit was finished, the electrode will be moved backward and in the superficial direction. Ablation will begin with 40 W of RF power. If a transient hyperechoic zone do not form at the electrode tip within 5-10 seconds, RF power was increased in 10-W increments up to (100) W. If the patient do not tolerate pain during the ablation, the RF power will be reduced or turned off. Ablation will be terminated when all imaginary units had changed to transient hyperechoic zones.
Investigators will check for any possible complications both during and immediately after the procedure in order to assess its safety. Procedure-related pain will be graded into four categories, i.e. grade 0, RF power did not have to be turned off because a patient experienced no pain; grade 1, RF power was turned off 1-2 times because the patient's pain; grade 2, RF power was turned off more than three times because of the patient's pain; and grade 3, RF procedure was incompletely terminated due to the patient's severe pain. After RF ablation, each patient will be observed for 1-2 hours while still in the hospital.
Ethanol Ablation A 16- or 18-gauge needle will be inserted into the nodule through an isthmus. After the needle tip is placed into the cystic portion, the internal fluid will be aspirated to the maximal extent possible, followed by slow injection of 99% ethanol into the cystic space. If the cyst contents are viscous, Investigators will aspirate viscous fluid using a large-bore needle (16-gauge) attached to a 30-mL syringe, and followed by irrigation with normal saline to remove viscous material attached to the cystic wall or solid component, after which ethanol will be injected. The volume of ethanol injected usually corresponded to 50% of the aspirated volume. After 2 minutes of ethanol retention with the needle in place, the injected ethanol will be completely removed and the needle was withdrawn. Investigators will not inject the ethanol to solid component. In order to assess its safety, Investigators will check for any complications during and immediately after the procedure. Procedure-related pain will be graded into four categories, i.e. grade 0, no pain or mild pain similar to pain experienced during the lidocaine injection; grade 1, pain greater than that of the lidocaine injection, but not requiring medication; grade 2, pain requiring medication; and grade 3, the procedure was incompletely terminated due to severe pain (1). Following the procedure, each patient was observed for 30 minutes while still in the hospital.
- Conditions
- Thyroid Nodule
- Being tested
- radiofrequency ablation, Ethanol ablation
- Keywords
- Ultrasound, Radiofrequency, Ethanol, Predominantly cystic thyroid nodule, Thyroid nodule, Thyroid
- Medical subject headings
- Thyroid Nodule, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency ablationProcedure or surgery
radiofrequency ablation for the treatment as a new therapy as compared with ethanol ablation as a conventional therapy
Ethanol ablationProcedure or surgery
ethanol ablation as a conventional/control therapy to be compared with a new experimental therapy--radiofrequency ablation
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablation | Experimental | Treatment with radiofrequency ablation for the thyroid lesions and compare the results with ethanol ablation in terms of volume reduction at 6-month follow-up (primary end point). Receives: Procedure: radiofrequency ablation |
| Ethanol | Active comparator | Treatment of predominantly cystic nodule with ethanol ablation and compare these results to radiofrequency ablation in terms of volume reduction at 6-month follow-up. Receives: Procedure: Ethanol ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
quantitative volume reduction ratio of a thyroid lesion at six months following compared with before the ablation treatment
Measured: at six months following compared with before the ablation treatment
Secondary outcomes (1)
binary therapeutic success rate which was defined as the proportion of patients who showed volume reduction >50%, improvement of symptomatic and cosmetic scores, and the number of major complications
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionMay 2013
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung Hwan Baek, Asan Medical Center
- Investigators
- Jung Hwan Baek, MD, Study chair, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778400
- Sponsor's protocol ID
- BJH_PCYST
- Status last verified
- Nov 2013
- First submitted
- 25 Jan 2013
- Last updated
- 11 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Session Treatment of RFA Versus EA for Predominantly Cystic Thyroid Nodules: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01778400
- Acronym / sponsor ID
- BJH_PCYST
- Conditions
- Thyroid Nodule
- Keywords
- Ultrasound, Radiofrequency, Ethanol, Predominantly cystic thyroid nodule, Thyroid nodule, Thyroid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2013 (actual)
- Study completion
- Jan 2014 (estimated)
- First posted
- 29 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ultrasound-guided ethanol ablation is an effective treatment modality for patients with cystic thyroid nodules (cystic portion > 90%); however it is less effective in predominantly cystic thyroid nodules (90% > cystic portions > 50%). The volume reduction after EA has been reported 64% - 69.8% for predominantly cystic thyroid nodules. EA is insufficient for 26% (27/103) of patients with predominantly cystic thyroid nodules. Radiofrequency ablation to patients with incompletely resolved clinical problems after EA and the mean volume reduction ratio was 92% at 6-month follow-up. It is well known that RF ablation is effective in both predominantly cystic and solid thyroid nodules. Although RF ablation has effectively treated the patients who were unsatisfactory after EA, to the best of our knowledge, no study to date has compared these two ablation techniques. Therefore investigators performed a prospective randomized study to compare single-session RF ablation and EA for treating predominantly cystic thyroid nodules.
Detailed description
Ablation Procedures Both RF ablation and EA will perform with each patient in the supine position and with mild neck extension. Before the treatment, investigators will measure the three orthogonal diameters of each nodule, i.e, the largest diameter and two other, mutually perpendicular diameters, and the volume of each nodule was calculated using the equation V = π abc/6, where V is the volume, a is the largest diameter, and b and c are the other two diameters. Investigators will use 2% lidocaine at skin puncture site. The skin will be punctured, and target nodules will be approached using the trans-isthmic approach method in which the RF ablation electrode or EA needle is inserted into the short axis of the nodule from the isthmus to the targeting nodule. This technical approach has several advantages. It can prevent a change in the position of the needle or electrode when the patient is swallowing or talking during the ablation and can also prevent fluid leakage, i.e. injected ethanol or ablated, hot fluid of the cystic portion of thyroid nodules, to areas outside the thyroid gland. This approach also allows clear, continuous US monitoring of the relationship of the nodule, the needle or electrode tip, and the expected location of the recurrent laryngeal nerve, thus minimizing the risks of injury to that nerve and/or the esophagus.
Radiofrequency Ablation All patients will be required to fast for at least six hours before each procedure. Before starting the RF ablation, investigators will aspirate the internal fluid as much as possible .
Moving shot technique for thyroid RF ablation has been proposed. In treatment of the liver, the electrode is fixed during ablation. Because the thyroid is a relatively small organ compared with the liver, prolonged fixation of the electrode is dangerous. Investigators therefore divide thyroid nodules into multiple conceptual ablation units, and perform RF ablation unit by unit by moving the electrode tip. These conceptual ablation units are smaller in the periphery of the nodule and in the portion of the nodule adjacent to the critical structures of the neck; however the units are larger in the central safe portion. Initially, the electrode tip will be positioned in the deepest, most remote imaginary unit of the nodule to enable easy monitoring of the electrode tip without the disturbance caused by microbubbles. The electrode moves within the thyroid mass by tilting it upward or downward. When ablation in the peripheral unit was finished, the electrode will be moved backward and in the superficial direction. Ablation will begin with 40 W of RF power. If a transient hyperechoic zone do not form at the electrode tip within 5-10 seconds, RF power was increased in 10-W increments up to (100) W. If the patient do not tolerate pain during the ablation, the RF power will be reduced or turned off. Ablation will be terminated when all imaginary units had changed to transient hyperechoic zones.
Investigators will check for any possible complications both during and immediately after the procedure in order to assess its safety. Procedure-related pain will be graded into four categories, i.e. grade 0, RF power did not have to be turned off because a patient experienced no pain; grade 1, RF power was turned off 1-2 times because the patient's pain; grade 2, RF power was turned off more than three times because of the patient's pain; and grade 3, RF procedure was incompletely terminated due to the patient's severe pain. After RF ablation, each patient will be observed for 1-2 hours while still in the hospital.
Ethanol Ablation A 16- or 18-gauge needle will be inserted into the nodule through an isthmus. After the needle tip is placed into the cystic portion, the internal fluid will be aspirated to the maximal extent possible, followed by slow injection of 99% ethanol into the cystic space. If the cyst contents are viscous, Investigators will aspirate viscous fluid using a large-bore needle (16-gauge) attached to a 30-mL syringe, and followed by irrigation with normal saline to remove viscous material attached to the cystic wall or solid component, after which ethanol will be injected. The volume of ethanol injected usually corresponded to 50% of the aspirated volume. After 2 minutes of ethanol retention with the needle in place, the injected ethanol will be completely removed and the needle was withdrawn. Investigators will not inject the ethanol to solid component. In order to assess its safety, Investigators will check for any complications during and immediately after the procedure. Procedure-related pain will be graded into four categories, i.e. grade 0, no pain or mild pain similar to pain experienced during the lidocaine injection; grade 1, pain greater than that of the lidocaine injection, but not requiring medication; grade 2, pain requiring medication; and grade 3, the procedure was incompletely terminated due to severe pain (1). Following the procedure, each patient was observed for 30 minutes while still in the hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablation | Experimental | Procedure: radiofrequency ablationTreatment with radiofrequency ablation for the thyroid lesions and compare the results with ethanol ablation in terms of volume reduction at 6-month follow-up (primary end point). |
| Ethanol | Active comparator | Procedure: Ethanol ablationTreatment of predominantly cystic nodule with ethanol ablation and compare these results to radiofrequency ablation in terms of volume reduction at 6-month follow-up. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with predominantly cystic thyroid nodules (90% > cystic portion > 50%)
- reports of pressure symptoms or cosmetic problems
- cytologic confirmation of benignancy in at least two, separate US-guided, fine-needle aspiration cytology or core needle biopsy for cystic fluid and/or a mural, solid component
- serum levels of thyroid hormone, thyrotropin, and calcitonin within normal limits.
Key exclusion criteria (4 listed)
- nodules showing malignant features, i.e. taller than wide, spiculated margin, markedly hypoechoic, micro- or macrocalcifications, on US
- lack of informed consent
- less than 20 years old
- pregnant woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiofrequency ablationradiofrequency ablation for the treatment as a new therapy as compared with ethanol ablation as a conventional therapy | Procedure or surgery | Radiofrequency ablation |
| Ethanol ablationethanol ablation as a conventional/control therapy to be compared with a new experimental therapy--radiofrequency ablation | Procedure or surgery | Ethanol |
Primary outcome
quantitative volume reduction ratio of a thyroid lesion at six months following compared with before the ablation treatment
Time frame: at six months following compared with before the ablation treatment
1 secondary outcome
binary therapeutic success rate which was defined as the proportion of patients who showed volume reduction >50%, improvement of symptomatic and cosmetic scores, and the number of major complications
Time frame: 6-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung Hwan Baek, MD study chair
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiofrequency ablation and Ethanol ablation in people with Thyroid Nodule, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quantitative volume reduction ratio of a thyroid lesion at six months following compared with before the ablation treatment (time frame: at six months following compared with before the ablation treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2013.