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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
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.
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
RECRUITINGStructural Recurrence-Free Survival
Proportion of participants without local, regional, or distant structural recurrence confirmed by imaging ± cytopathology.
Time frame: 24 months
Endocrine-Function Preservation
Participants alive and free from lifelong levothyroxine therapy and permanent hypocalcemia (serum Ca ≥2.1 mmol/L without supplementation).
Time frame: 24 months
Permanent RLN Palsy Incidence
Laryngoscopy-confirmed vocal-fold mobility disorder persisting ≥6 months.
Time frame: 12 months
Permanent Hypocalcemia Incidence
Need for calcium/vit-D \>6 months after surgery.
Time frame: 12 months
Nodule Volume Reduction Rate
Percentage reduction of ablated nodule volume on ultrasound.
Time frame: 12 months
Procedure-Related Adverse Events
Any CTCAE v5.0 Grade ≥3 event within 30 days.
Time frame: 30 days
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