Hybrid Endoscopic Hemithyroidectomy and Targeted Ablation for Bilateral Papillary Thyroid Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopic Hemithyroidectomy with Central-Neck Dissection, Ultrasound-Guided Radiofrequency Ablation of Contralateral Nodule.
- Who it may be relevant to
- Registry conditions: Thyroid Neoplasms, Carcinoma, Papillary. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Procedure Endoscopic 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. - Procedure Ultrasound-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.
Primary outcome measures
- Structural Recurrence-Free Survival [Time frame: 24 months]
- Endocrine-Function Preservation [Time frame: 24 months]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fujian Medical University Union Hospital — Fuzhou
Identifiers
NCT: NCT07033572 · Hybrid