Hybrid Endoscopic Hemithyroidectomy and Targeted Ablation for Bilateral Papillary Thyroid Carcinoma

Fujian Medical University

Status: Enrolling

Conditions: Carcinoma, Papillary; Thyroid Neoplasms

Treatments: Procedure: Endoscopic Hemithyroidectomy with Central-Neck Dissection; Procedure: Ultrasound-Guided Radiofrequency Ablation of Contralateral Nodule

Study type: Interventional

Funder types: Other

Identifiers

NCT07033572

Hybrid

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Hybrid Endoscopic Hemithyroidectomy + Same-Session Contralateral RFA

Experimental group

Description:

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.

Treatment:

Procedure: Ultrasound-Guided Radiofrequency Ablation of Contralateral Nodule

Procedure: Endoscopic Hemithyroidectomy with Central-Neck Dissection