Thyroid NeoplasmsNCT07033572
Hybrid Endoscopic Hemithyroidectomy and Targeted Ablation for Bilateral Papillary Thyroid Carcinoma
A study testing Endoscopic Hemithyroidectomy with Central-Neck Dissection and Ultrasound-Guided Radiofrequency Ablation of Contralateral Nodule in people with Thyroid Neoplasms and Carcinoma, Papillary, run by Fujian Medical University at 1 site in China.
Trial summary
This study evaluates a thyroid-function-preserving alternative to routine total thyroidectomy for bilateral papillary thyroid carcinoma (PTC). Eligible adults undergo remote-access gas-less axillo-breast endoscopic hemithyroidectomy with level VI dissection on the dominant side, followed by ultrasound-guided… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thyroid Neoplasms, Carcinoma, Papillary
- What is being tested?
- Endoscopic Hemithyroidectomy with Central-Neck Dissection and Ultrasound-Guided Radiofrequency Ablation of Contralateral Nodule
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 30 Jun 2028
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years.
- Dominant-side PTC ≤1.5 cm suitable for endoscopic resection.
- Contralateral nodule ≤7 mm located ≥2 mm from posterior capsule.
- No radiologic lymph-node metastasis on contralateral side.
- Written informed consent.
Who cannot join
- Extrathyroidal extension, gross nodal or distant metastasis.
- Prior neck surgery, prior RFA/ethanol injection, or neck irradiation.
- Pregnancy or lactation.
- Serious comorbidities precluding anesthesia or follow-up.
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, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Bo Wang Porfessor, MD, +13959123550, wangbo@fjmu.edu.cn
Bo Wang MD, Principal Investigator
About this study
This study evaluates a thyroid-function-preserving alternative to routine total thyroidectomy for bilateral papillary thyroid carcinoma (PTC). Eligible adults undergo remote-access gas-less axillo-breast endoscopic hemithyroidectomy with level VI dissection on the dominant side, followed by ultrasound-guided radiofrequency ablation (RFA) of a ≤7 mm contralateral focus during the same anesthesia. Outcomes include structural-recurrence-free survival, endocrine-function preservation, safety, and quality of life over 24 months.
Read the detailed description
Bilateral PTC traditionally prompts total thyroidectomy, exposing patients to lifelong thyroxine replacement and a 1 - 3 % risk of permanent hypocalcemia. Building on a pilot cohort of 11 patients treated from June 2018 to September 2024 that showed no structural recurrence, no permanent RLN palsy, and preserved endocrine function after a median 17-month follow-updraft_Proof_hi, we launch a multicenter registry to confirm oncologic adequacy and functional benefits. Intervention: endoscopic hemithyroidectomy (dominant lobe) via gas-less axillo-breast approach plus central-neck dissection; then contralateral lesion RFA with a 17-gauge 0.7-cm active-tip electrode at 40 W (moving-shot). Follow-up at 1, 6, 12, 18, and 24 months includes ultrasound, serum Tg, calcium, PTH, and QoL instruments. Long-term surveillance continues annually to five years.
- Conditions
- Thyroid Neoplasms, Carcinoma, Papillary
- Being tested
- Endoscopic Hemithyroidectomy with Central-Neck Dissection, Ultrasound-Guided Radiofrequency Ablation of Contralateral Nodule
- Keywords
- Hybrid endoscopic thyroidectomy, Radiofrequency ablation, Thyroid function preservation, Bilateral Thyroid Carcinoma
- Medical subject headings
- Thyroid Neoplasms, Carcinoma, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Hemithyroidectomy with Central-Neck DissectionProcedure or surgery
Gas-less axillo-breast approach (trans-axillary + peri-areolar), carbon-dioxide-free working space, removing dominant thyroid lobe plus level VI lymph nodes; intra-operative neuromonitoring used throughout.
Ultrasound-Guided Radiofrequency Ablation of Contralateral NoduleProcedure or surgery
17-gauge internally-cooled electrode, 0.7 cm active tip, power 40 W; moving-shot technique under real-time ultrasound until hyperechoic halo fully covers ≤ 7 mm papillary microcarcinoma ≥ 2 mm from posterior capsule; same anesthesia session as surgery.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Endoscopic Hemithyroidectomy + Same-Session Contralateral RFA | Experimental | Remote-access gas-less axillo-breast endoscopic hemithyroidectomy with level VI central-neck dissection on the dominant lobe, immediately followed-under the same anesthesia-by ultrasound-guided radiofrequency ablation (17-G, 0.7 cm active tip, 40 W, moving-shot technique) of a ≤ 7 mm contralateral papillary thyroid microcarcinoma. Receives: Procedure: Endoscopic Hemithyroidectomy with Central-Neck Dissection; Procedure: Ultrasound-Guided Radiofrequency Ablation of Contralateral Nodule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structural Recurrence-Free Survival
Proportion of participants without local, regional, or distant structural recurrence confirmed by imaging ± cytopathology.
Measured: 24 months
Endocrine-Function Preservation
Participants alive and free from lifelong levothyroxine therapy and permanent hypocalcemia (serum Ca ≥2.1 mmol/L without supplementation).
Measured: 24 months
Secondary outcomes (4)
Permanent RLN Palsy Incidence
Laryngoscopy-confirmed vocal-fold mobility disorder persisting ≥6 months.
Measured: 12 months
Permanent Hypocalcemia Incidence
Need for calcium/vit-D >6 months after surgery.
Measured: 12 months
Nodule Volume Reduction Rate
Percentage reduction of ablated nodule volume on ultrasound.
Measured: 12 months
Procedure-Related Adverse Events
Any CTCAE v5.0 Grade ≥3 event within 30 days.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Jun 2018
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NeoplasmsStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Wang,MD, Fujian Medical University
- Investigators
- Bo Wang MD, Principal Investigator, Principal investigator, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033572
- Sponsor's protocol ID
- Hybrid
- Status last verified
- Jul 2025
- First submitted
- 13 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Endoscopic Hemithyroidectomy and Targeted Ablation for Bilateral Papillary Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT07033572
- Acronym / sponsor ID
- Hybrid
- Conditions
- Thyroid Neoplasms, Carcinoma, Papillary
- Keywords
- Hybrid endoscopic thyroidectomy, Radiofrequency ablation, Thyroid function preservation, Bilateral Thyroid Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 24 Jun 2025 (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.
This study evaluates a thyroid-function-preserving alternative to routine total thyroidectomy for bilateral papillary thyroid carcinoma (PTC). Eligible adults undergo remote-access gas-less axillo-breast endoscopic hemithyroidectomy with level VI dissection on the dominant side, followed by ultrasound-guided radiofrequency ablation (RFA) of a ≤7 mm contralateral focus during the same anesthesia. Outcomes include structural-recurrence-free survival, endocrine-function preservation, safety, and quality of life over 24 months.
Detailed description
Bilateral PTC traditionally prompts total thyroidectomy, exposing patients to lifelong thyroxine replacement and a 1 - 3 % risk of permanent hypocalcemia. Building on a pilot cohort of 11 patients treated from June 2018 to September 2024 that showed no structural recurrence, no permanent RLN palsy, and preserved endocrine function after a median 17-month follow-updraft_Proof_hi, we launch a multicenter registry to confirm oncologic adequacy and functional benefits. Intervention: endoscopic hemithyroidectomy (dominant lobe) via gas-less axillo-breast approach plus central-neck dissection; then contralateral lesion RFA with a 17-gauge 0.7-cm active-tip electrode at 40 W (moving-shot). Follow-up at 1, 6, 12, 18, and 24 months includes ultrasound, serum Tg, calcium, PTH, and QoL instruments. Long-term surveillance continues annually to five years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hybrid Endoscopic Hemithyroidectomy + Same-Session Contralateral RFA | Experimental | Procedure: Endoscopic Hemithyroidectomy with Central-Neck Dissection, Procedure: Ultrasound-Guided Radiofrequency Ablation of Contralateral NoduleRemote-access gas-less axillo-breast endoscopic hemithyroidectomy with level VI central-neck dissection on the dominant lobe, immediately followed-under the same anesthesia-by ultrasound-guided radiofrequency ablation (17-G, 0.7 cm active tip, 40 W, moving-shot technique) of a ≤ 7 mm contralateral papillary thyroid microcarcinoma. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65 years.
- Dominant-side PTC ≤1.5 cm suitable for endoscopic resection.
- Contralateral nodule ≤7 mm located ≥2 mm from posterior capsule.
- No radiologic lymph-node metastasis on contralateral side.
- Written informed consent.
Key exclusion criteria (4 listed)
- Extrathyroidal extension, gross nodal or distant metastasis.
- Prior neck surgery, prior RFA/ethanol injection, or neck irradiation.
- Pregnancy or lactation.
- Serious comorbidities precluding anesthesia or follow-up.
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 |
|---|---|---|
| Endoscopic Hemithyroidectomy with Central-Neck DissectionGas-less axillo-breast approach (trans-axillary + peri-areolar), carbon-dioxide-free working space, removing dominant thyroid lobe plus level VI lymph nodes; intra-operative neuromonitoring used throughout. | Procedure or surgery | Hybrid Endoscopic Hemithyroidectomy + Same-Session Contralateral RFA |
| Ultrasound-Guided Radiofrequency Ablation of Contralateral Nodule17-gauge internally-cooled electrode, 0.7 cm active tip, power 40 W; moving-shot technique under real-time ultrasound until hyperechoic halo fully covers ≤ 7 mm papillary microcarcinoma ≥ 2 mm from posterior capsule; same anesthesia session as surgery. | Procedure or surgery | Hybrid Endoscopic Hemithyroidectomy + Same-Session Contralateral RFA |
Primary outcome
Structural Recurrence-Free Survival
Time frame: 24 months
Proportion of participants without local, regional, or distant structural recurrence confirmed by imaging ± cytopathology.
Endocrine-Function Preservation
Time frame: 24 months
Participants alive and free from lifelong levothyroxine therapy and permanent hypocalcemia (serum Ca ≥2.1 mmol/L without supplementation).
4 secondary outcomes
Permanent RLN Palsy Incidence
Time frame: 12 months
Permanent Hypocalcemia Incidence
Time frame: 12 months
Nodule Volume Reduction Rate
Time frame: 12 months
Procedure-Related Adverse Events
Time frame: 30 days
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 3 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Bo Wang MD, Principal Investigator principal investigator
Fujian Medical University Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Hemithyroidectomy with Central-Neck Dissection and Ultrasound-Guided Radiofrequency Ablation of Contralateral Nodule in people with Thyroid Neoplasms and Carcinoma, Papillary, run by Fujian Medical University 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 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: looking for participants now, as of the sponsor's last update on 3 Jul 2025. 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 Bo Wang Professor, MD (+13959123550, wangbo@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structural Recurrence-Free Survival (time frame: 24 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 3 Jul 2025.