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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Hemithyroidectomy with Central-Neck Dissection | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Structural Recurrence-Free Survival | Proportion of participants without local, regional, or distant structural recurrence confirmed by imaging ± cytopathology. | 24 months |
| Endocrine-Function Preservation | Participants alive and free from lifelong levothyroxine therapy and permanent hypocalcemia (serum Ca ≥2.1 mmol/L without supplementation). | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Permanent RLN Palsy Incidence | Laryngoscopy-confirmed vocal-fold mobility disorder persisting ≥6 months. | 12 months |
| Permanent Hypocalcemia Incidence | Need for calcium/vit-D >6 months after surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bo Wang Professor, MD | Contact | +13959123550 | wangbo@fjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Bo Wang MD, Principal Investigator | Fujian Medical University Union Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Recruiting | Fuzhou | Fujian | 350001 | China |
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| Ultrasound-Guided Radiofrequency Ablation of Contralateral Nodule | Procedure | 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. |
|
| 12 months |
| Nodule Volume Reduction Rate | Percentage reduction of ablated nodule volume on ultrasound. | 12 months |
| Procedure-Related Adverse Events | Any CTCAE v5.0 Grade ≥3 event within 30 days. | 30 days |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D002291 | Carcinoma, Papillary |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
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