Carcinoma, Papillary, Thyroid Neoplasms
Conditions
Keywords
Hybrid endoscopic thyroidectomy, Radiofrequency ablation, Thyroid function preservation, Bilateral Thyroid Carcinoma
Brief 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 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.
Interventions
PROCEDUREEndoscopic Hemithyroidectomy with Central-Neck Dissection
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.
PROCEDUREUltrasound-Guided Radiofrequency Ablation of Contralateral Nodule
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.
Sponsors
Fujian Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Structural Recurrence-Free Survival | 24 months | Proportion of participants without local, regional, or distant structural recurrence confirmed by imaging ± cytopathology. |
| Endocrine-Function Preservation | 24 months | Participants alive and free from lifelong levothyroxine therapy and permanent hypocalcemia (serum Ca ≥2.1 mmol/L without supplementation). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Permanent RLN Palsy Incidence | 12 months | Laryngoscopy-confirmed vocal-fold mobility disorder persisting ≥6 months. |
| Permanent Hypocalcemia Incidence | 12 months | Need for calcium/vit-D \>6 months after surgery. |
| Nodule Volume Reduction Rate | 12 months | Percentage reduction of ablated nodule volume on ultrasound. |
| Procedure-Related Adverse Events | 30 days | Any CTCAE v5.0 Grade ≥3 event within 30 days. |
Countries
China
Contacts
Primary ContactBo Wang Professor, MD
Outcome results
None listed