Benign Thyroid NodulesNCT06607133
Thermal Ablation Vs Thyroidectomy for Large Benign Thyroid Nodules
An observational study of Benign Thyroid Nodules, run by Ming-an Yu at 1 site in China.
Trial summary
To compare the safety, efficacy and quality of life between staged thermal ablation and thyroidectomy in the treatment of Large benign thyroid nodules. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Benign Thyroid Nodules
- What is being tested?
- surgery and staged thermal ablation
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2024to Dec 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients treated with surgery, or staged thermal ablation in China-Japan Friendship Hospital
Who may be able to join
- benign thyroid nodules confirmed by surgical pathology in surgery group, and by two separate US-guided fine-needle aspiration (FNA) or core needle biopsy (CNB) in thermal ablation group;
- the largest diameter of the nodule ≥4 cm;
- the presence of nodule-related symptoms, cosmetic concerns, or psychological stress;
- patients treated with surgery, or staged thermal ablation (who explicitly refused surgery);
- more than 12-month follow-up duration
Who cannot join
- suspicion of malignant nodule on ultrasound findings (e.g., marked hypoechoic, microcalcifications, or ill-defined margins);
- comorbidities of other severe diseases;
- without complete treatment and/or follow-up information
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
About this study
Official title: Comparison of Staged Thermal Ablation and Thyroidectomy for Large Benign Thyroid Nodules
To compare the safety, efficacy and quality of life between staged thermal ablation and thyroidectomy in the treatment of Large benign thyroid nodules.
Read the detailed description
Large benign thyroid nodules （BTNs）usually cause compressive symptoms or cosmetic concerns and therefore require treatment. Thyroidectomy remains the mainstay treatment for large, symptomatic BTNs. However, if surgery is not feasible or refused, ablative approach could be considered in selected patients. However, it has been proved that single application of thermal ablation is less effective in causing shrinkage in large thyroid nodules. The possible reason is that it is difficult for single application of thermal ablation to cover all of the nodule tissue in a three-dimension if the nodule is large. In addition, nodule locations adjacent to vital structures might hinder complete treatment in one session because of safety concerns. Few studies reveal that staged thermal ablation (Pre-designed multiple sessions of thermal ablation) can also achieve complete ablation and adequate volume reduction of large benign thyroid nodules. However, there is a lack of comparison between these two methods. Thus, this study is aimed to compare the safety, efficacy, quality of life between staged thermal ablation and thyroidectomy for treating large benign thyroid nodules.
- Conditions
- Benign Thyroid Nodules
- Being tested
- surgery, staged thermal ablation
- Keywords
- thermal ablation, Thyroidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
patients undergo conventional/open thyroidectomy or endoscopic thyroidectomy for large benign thyroid nodules
staged thermal ablationProcedure or surgery
patients undergo multiple sessions of thermal ablation for large benign thyroid nodules
| Study group | Role | What they receive |
|---|---|---|
| surgery group | patients treated with thyroidectomy for benign thyroid nodules Receives: Procedure: surgery | |
| thermal ablation group | patients treated with staged thermal ablation for benign thyroid nodules Receives: Procedure: staged thermal ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
volume reduction ratio
The volume reduction ratio(VRR) = [(preoperative volume - volume at the follow-up point)/preoperative volume] × 100%. The volumes of the nodules were calculated using the following equation: V=π/6 a×b×c (where V is the volume, a is the maximum diameter, b and c are the other two perpendicular diameters).
Measured: From enrollment to the end of treatment at 12 months
Complications
Complications related to thermal ablation or thyroidectomy during treatment procedures, at the hospital stay and follow-ups.
Measured: From enrollment to the end of treatment at 12 months
Secondary outcomes (2)
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire
Questionnaires of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) was used to evaluate the quality of life for cancer patients. All scales and single-item measures range from score 0-100 after linear transformation. The summary score of QLQ-C30 is used to measure the overall health-related quality-of-life (HRQoL), with a lower score indicating poorer HRQoL. And a higher score on the functional scales and global status scale indicates a better level of functioning and HRQoL, while a higher score on the symptom scales and single item means more discomfort and complaints.
Measured: From enrollment to the end of treatment at 12 months
Thyroid Cancer-Specific Quality of Life questionnaire
The Thyroid Cancer-Specific Quality of Life questionnaire (THYCA-QoL) was used to assess thyroid-specific symptoms in thyroid cancer survivors. The questionnaire consists of seven symptom scales (including neuromuscular, voice, concentration, sympathetic, throat/mouth, psychological and sensory problems) and six single items (including problems with scar, feeling chilly, tingling hands/feet, gained weight, headache, less interest in sex). A higher score on this scale implies more symptoms and complaints.
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start10 Sep 2024 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Thyroid NodulesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Ming-an Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ming-an Yu, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607133
- Sponsor's protocol ID
- S2019-283-02
- Status last verified
- Aug 2024
- First submitted
- 8 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available because of the patients privacy.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Staged Thermal Ablation and Thyroidectomy for Large Benign Thyroid Nodules
- ClinicalTrials.gov ID
- NCT06607133
- Acronym / sponsor ID
- S2019-283-02
- Conditions
- Benign Thyroid Nodules
- Keywords
- thermal ablation, Thyroidectomy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ming-an YuUniversity, hospital or other
- Study start
- 10 Sep 2024 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Sep 2024 (actual)
- 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.
To compare the safety, efficacy and quality of life between staged thermal ablation and thyroidectomy in the treatment of Large benign thyroid nodules.
Detailed description
Large benign thyroid nodules （BTNs）usually cause compressive symptoms or cosmetic concerns and therefore require treatment. Thyroidectomy remains the mainstay treatment for large, symptomatic BTNs. However, if surgery is not feasible or refused, ablative approach could be considered in selected patients. However, it has been proved that single application of thermal ablation is less effective in causing shrinkage in large thyroid nodules. The possible reason is that it is difficult for single application of thermal ablation to cover all of the nodule tissue in a three-dimension if the nodule is large. In addition, nodule locations adjacent to vital structures might hinder complete treatment in one session because of safety concerns. Few studies reveal that staged thermal ablation (Pre-designed multiple sessions of thermal ablation) can also achieve complete ablation and adequate volume reduction of large benign thyroid nodules. However, there is a lack of comparison between these two methods. Thus, this study is aimed to compare the safety, efficacy, quality of life between staged thermal ablation and thyroidectomy for treating large benign thyroid nodules.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery group | – | Procedure: surgerypatients treated with thyroidectomy for benign thyroid nodules |
| thermal ablation group | – | Procedure: staged thermal ablationpatients treated with staged thermal ablation for benign thyroid nodules |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients treated with surgery, or staged thermal ablation in China-Japan Friendship Hospital
Key inclusion criteria (5 listed)
- benign thyroid nodules confirmed by surgical pathology in surgery group, and by two separate US-guided fine-needle aspiration (FNA) or core needle biopsy (CNB) in thermal ablation group;
- the largest diameter of the nodule ≥4 cm;
- the presence of nodule-related symptoms, cosmetic concerns, or psychological stress;
- patients treated with surgery, or staged thermal ablation (who explicitly refused surgery);
- more than 12-month follow-up duration
Key exclusion criteria (3 listed)
- suspicion of malignant nodule on ultrasound findings (e.g., marked hypoechoic, microcalcifications, or ill-defined margins);
- comorbidities of other severe diseases;
- without complete treatment and/or follow-up information
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 |
|---|---|---|
| surgerypatients undergo conventional/open thyroidectomy or endoscopic thyroidectomy for large benign thyroid nodules | Procedure or surgery | surgery group |
| staged thermal ablationpatients undergo multiple sessions of thermal ablation for large benign thyroid nodules | Procedure or surgery | thermal ablation group |
Primary outcome
volume reduction ratio
Time frame: From enrollment to the end of treatment at 12 months
The volume reduction ratio(VRR) = [(preoperative volume - volume at the follow-up point)/preoperative volume] × 100%. The volumes of the nodules were calculated using the following equation: V=π/6 a×b×c (where V is the volume, a is the maximum diameter, b and c are the other two perpendicular diameters).
Complications
Time frame: From enrollment to the end of treatment at 12 months
Complications related to thermal ablation or thyroidectomy during treatment procedures, at the hospital stay and follow-ups.
2 secondary outcomes
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire
Time frame: From enrollment to the end of treatment at 12 months
Thyroid Cancer-Specific Quality of Life questionnaire
Time frame: From enrollment to the end of treatment at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available because of the patients privacy.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Thyroid Nodules, run by Ming-an Yu at 1 site in China.
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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 23 Sep 2024. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming-an Yu, MD (86-84205756, yma301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
volume reduction ratio (time frame: From enrollment to the end of treatment at 12 months). The study lists 2 primary outcomes in all. 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 23 Sep 2024; AzTrials last refreshed its copy on 30 Oct 2026.