Thyroid CancerNCT06583057
Multicenter Comparison of Thermal Ablation Versus Thyroid Lobectomy for Subcapsular Papillary Thyroid Microcarcinoma
An observational study of Thyroid Cancer and Papillary Thyroid Microcarcinoma, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
To compare the clinical outcomes of Thermal ablation with those of thyroid lobectomy in patients with subcapsular papillary thyroid microcarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer, Papillary Thyroid Microcarcinoma
- What is being tested?
- Thermal ablation and Thyroid lobectomy
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Jul 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: This study included patients with clinical T1aN0M0 PTC who underwent thermal ablation or thyroid lobectomy at three institutions between June 2014 and December 2020.
Who may be able to join
- a unifocal papillary thyroid carcinoma (PTC) diagnosed by fine-needle aspiration or core-needle biopsy;
- tumor with a maximum diameter of ≤ 10 mm detected on ultrasound;
- tumor located within ≤ 2mm from the thyroid capsule (with or without tumor-associated capsular bulging or capsular discontinuity);
- absence of clinical or imaging evidence of gross ETE (involvement of strap muscles, obtuse angles between the tumor and trachea/esophagus, protrusion into the tracheoesophageal groove, and invasion into other neck structures);
- no clinical or imaging evidence suggesting lymph node metastasis or distant metastasis
Who cannot join
- aggressive subtypes of PTC (aggressive subtypes of PTC includes the tall cell, columnar cell, solid, and hobnail variants);
- multifocal PTMC;
- history of neck surgery or TA;
- a follow-up period of < 24 months;
- incomplete follow-up data, or poor-quality pre-treatment ultrasound images
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Comparison of Thermal Ablation Versus Thyroid Lobectomy for Subcapsular Papillary Thyroid Microcarcinoma: a Retrospective Cohort Study
To compare the clinical outcomes of Thermal ablation with those of thyroid lobectomy in patients with subcapsular papillary thyroid microcarcinoma.
Read the detailed description
The global incidence of papillary thyroid microcarcinoma (PTMC) has increased rapidly in recent decades because of improved ultrasound (US) detection and fine needle aspiration biopsy and has primarily contributed to the surge in cases of thyroid carcinoma. Given the indolent characteristics of most PTMCs, the American Thyroid Association guidelines recommend active surveillance for low-risk PTMC to prevent over-treatment. Nevertheless, in many countries, active surveillance poses challenges, including patient anxiety, limited medical resources, and insurance coverage limitations when adopted. Furthermore, many patients prefer treatment rather than active surveillance due to anxiety, a meta-analysis showed that a significant proportion of patients (8.7%-32%) who underwent delayed surgery without tumor progression during active surveillance. Thyroid lobectomy (TL), replacing total thyroidectomy is recommended as the first-line treatment for PTMC by several guidelines. However, there were still concerns remain regarding lifelong hormone replacement therapy, surgery-related complications, and the potential over-treatment associated with TL.
Thermal ablation (TA) has emerged as a viable alternative for the managing of PTMC within the thyroid gland, as evidenced by studies conducted across various Asian and European countries. It has been endorsed as an alternative treatment strategy to TL in clinical guidelines issued by multiple professional associations in Europe, Asia, and North America. However, controversy persists regarding its usefulness for subcapsular PTMC because of concerns about potential extrathyroidal extension (ETE) or occult lymph node metastasis (LNM), which may impact disease progression post-treatment. There are also technical challenges and safety issues when ablating subcapsular lesions. To date, a limited number of studies have reported the short-term efficacy of TA in treating subcapsular PTMC.However, these studies were constrained by small sample sizes and the absence of comparative analyses between the first-line treatment option, TL, and TA. Consequently, further research is needed to fully understand the role of TA in the therapeutic management of subcapsular PTMC and its potential as an alternative to TL.
Therefore, the aim of this multicenter study was to compare the clinical outcomes of TA with those of TL in patients with subcapsular PTMC.
- Conditions
- Thyroid Cancer, Papillary Thyroid Microcarcinoma
- Being tested
- Thermal ablation, Thyroid lobectomy
- Keywords
- Thermal ablation, Lobectomy, Ultrasound, Papillary thyroid microcarcinoma
- Medical subject headings
- Thyroid Neoplasms, Papillary Thyroid Microcarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal ablationProcedure or surgery
Also called Ablation technique
Patients who underwent thermal ablation were performed in the outpatient clinic's operating room under local anesthesia. Thermal ablation was performed under real-time ultrasound-guided. The 18-G bipolar radiofrequency applicator with a 0.9 cm active tip (CelonProSurge micro 100-T09, Olympus Surgical Technologies Europe) , or a 16-G/17-G cooled microwave antenna with a 0.3 cm tip (ECO-100A1, YIGAO MWA system Co., Ltd; KY-2000, Kangyou Medical, Nanjing, China) was used during ablation.
Thyroid lobectomyProcedure or surgery
Patients who underwent thyroid lobectomy were performed in the operating theater under general anesthesia. Lobectomy (or lobectomy plus isthmusectomy) with prophylactic central neck dissection were performed.
| Study group | Role | What they receive |
|---|---|---|
| Thermal ablation group | Patients with clinical T1aN0M0 subcapsular papillary thyroid carcinoma who underwent thermal ablation for treatment. Receives: Procedure: Thermal ablation; Procedure: Thyroid lobectomy | |
| Thyroid lobectomy group | Patients with clinical T1aN0M0 subcapsular papillary thyroid carcinoma who underwent thyroid lobectomy for treatment. Receives: Procedure: Thermal ablation; Procedure: Thyroid lobectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Interval between the date of treatment and the date of detection of disease progression or last follow-up.
Measured: From date of enrollment of the first patient until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Secondary outcomes (1)
Complication
Complications included hoarseness, infection, hematoma, airway obstruction, and permanent hypoparathyroidism.
Measured: From date of treatment until the date of first documented complication, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start1 Jan 2019
- Primary completion1 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yukun Luo, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583057
- Sponsor's protocol ID
- S2019-211-01
- Status last verified
- Sep 2024
- First submitted
- 23 Aug 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Some of the data generated or analyzed during the study are available from the corresponding author by reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Comparison of Thermal Ablation Versus Thyroid Lobectomy for Subcapsular Papillary Thyroid Microcarcinoma: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06583057
- Acronym / sponsor ID
- S2019-211-01
- Conditions
- Thyroid Cancer, Papillary Thyroid Microcarcinoma
- Keywords
- Thermal ablation, Lobectomy, Ultrasound, Papillary thyroid microcarcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 3 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 clinical outcomes of Thermal ablation with those of thyroid lobectomy in patients with subcapsular papillary thyroid microcarcinoma.
Detailed description
The global incidence of papillary thyroid microcarcinoma (PTMC) has increased rapidly in recent decades because of improved ultrasound (US) detection and fine needle aspiration biopsy and has primarily contributed to the surge in cases of thyroid carcinoma. Given the indolent characteristics of most PTMCs, the American Thyroid Association guidelines recommend active surveillance for low-risk PTMC to prevent over-treatment. Nevertheless, in many countries, active surveillance poses challenges, including patient anxiety, limited medical resources, and insurance coverage limitations when adopted. Furthermore, many patients prefer treatment rather than active surveillance due to anxiety, a meta-analysis showed that a significant proportion of patients (8.7%-32%) who underwent delayed surgery without tumor progression during active surveillance. Thyroid lobectomy (TL), replacing total thyroidectomy is recommended as the first-line treatment for PTMC by several guidelines. However, there were still concerns remain regarding lifelong hormone replacement therapy, surgery-related complications, and the potential over-treatment associated with TL.
Thermal ablation (TA) has emerged as a viable alternative for the managing of PTMC within the thyroid gland, as evidenced by studies conducted across various Asian and European countries. It has been endorsed as an alternative treatment strategy to TL in clinical guidelines issued by multiple professional associations in Europe, Asia, and North America. However, controversy persists regarding its usefulness for subcapsular PTMC because of concerns about potential extrathyroidal extension (ETE) or occult lymph node metastasis (LNM), which may impact disease progression post-treatment. There are also technical challenges and safety issues when ablating subcapsular lesions. To date, a limited number of studies have reported the short-term efficacy of TA in treating subcapsular PTMC.However, these studies were constrained by small sample sizes and the absence of comparative analyses between the first-line treatment option, TL, and TA. Consequently, further research is needed to fully understand the role of TA in the therapeutic management of subcapsular PTMC and its potential as an alternative to TL.
Therefore, the aim of this multicenter study was to compare the clinical outcomes of TA with those of TL in patients with subcapsular PTMC.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thermal ablation group | – | Procedure: Thermal ablation, Procedure: Thyroid lobectomyPatients with clinical T1aN0M0 subcapsular papillary thyroid carcinoma who underwent thermal ablation for treatment. |
| Thyroid lobectomy group | – | Procedure: Thermal ablation, Procedure: Thyroid lobectomyPatients with clinical T1aN0M0 subcapsular papillary thyroid carcinoma who underwent thyroid lobectomy for treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study included patients with clinical T1aN0M0 PTC who underwent thermal ablation or thyroid lobectomy at three institutions between June 2014 and December 2020.
Key inclusion criteria (5 listed)
- a unifocal papillary thyroid carcinoma (PTC) diagnosed by fine-needle aspiration or core-needle biopsy;
- tumor with a maximum diameter of ≤ 10 mm detected on ultrasound;
- tumor located within ≤ 2mm from the thyroid capsule (with or without tumor-associated capsular bulging or capsular discontinuity);
- absence of clinical or imaging evidence of gross ETE (involvement of strap muscles, obtuse angles between the tumor and trachea/esophagus, protrusion into the tracheoesophageal groove, and invasion into other neck structures);
- no clinical or imaging evidence suggesting lymph node metastasis or distant metastasis
Key exclusion criteria (5 listed)
- aggressive subtypes of PTC (aggressive subtypes of PTC includes the tall cell, columnar cell, solid, and hobnail variants);
- multifocal PTMC;
- history of neck surgery or TA;
- a follow-up period of < 24 months;
- incomplete follow-up data, or poor-quality pre-treatment ultrasound images
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 |
|---|---|---|
| Thermal ablationAlso: Ablation techniquePatients who underwent thermal ablation were performed in the outpatient clinic's operating room under local anesthesia. Thermal ablation was performed under real-time ultrasound-guided. The 18-G bipolar radiofrequency applicator with a 0.9 cm active tip (CelonProSurge micro 100-T09, Olympus Surgical Technologies Europe) , or a 16-G/17-G cooled microwave antenna with a 0.3 cm tip (ECO-100A1, YIGAO MWA system Co., Ltd; KY-2000, Kangyou Medical, Nanjing, China) was used during ablation. | Procedure or surgery | Thermal ablation group, Thyroid lobectomy group |
| Thyroid lobectomyPatients who underwent thyroid lobectomy were performed in the operating theater under general anesthesia. Lobectomy (or lobectomy plus isthmusectomy) with prophylactic central neck dissection were performed. | Procedure or surgery | Thermal ablation group, Thyroid lobectomy group |
Primary outcome
Progression-free survival
Time frame: From date of enrollment of the first patient until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Interval between the date of treatment and the date of detection of disease progression or last follow-up.
1 secondary outcome
Complication
Time frame: From date of treatment until the date of first documented complication, assessed up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: Undecided. Some of the data generated or analyzed during the study are available from the corresponding author by reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Thyroid Cancer and Papillary Thyroid Microcarcinoma, run by Chinese PLA General Hospital 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 5 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: finished, as of the sponsor's last update on 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progression-free survival (time frame: From date of enrollment of the first patient until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months). 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 3 Sep 2024.