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NCT Number: NCT07033572

Hybrid Endoscopic Hemithyroidectomy and Targeted Ablation for Bilateral Papillary Thyroid Carcinoma

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.

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Key information

Conditions

Thyroid Neoplasms Carcinoma Carcinoma, Papillary Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Thyroid Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location status: Recruiting

Location contact

Bo Wang MD, Principal Investigator

PRINCIPAL_INVESTIGATOR

Bo Wang Porfessor, MD

CONTACT

[email protected]

+13959123550

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Structural Recurrence-Free Survival

    Time frame: 24 months

    Proportion of participants without local, regional, or distant structural recurrence confirmed by imaging ± cytopathology.

  2. Endocrine-Function Preservation

    Time frame: 24 months

    Participants alive and free from lifelong levothyroxine therapy and permanent hypocalcemia (serum Ca ≥2.1 mmol/L without supplementation).

Secondary outcomes

  1. Permanent RLN Palsy Incidence

    Time frame: 12 months

    Laryngoscopy-confirmed vocal-fold mobility disorder persisting ≥6 months.

  2. Permanent Hypocalcemia Incidence

    Time frame: 12 months

    Need for calcium/vit-D >6 months after surgery.

  3. Nodule Volume Reduction Rate

    Time frame: 12 months

    Percentage reduction of ablated nodule volume on ultrasound.

  4. Procedure-Related Adverse Events

    Time frame: 30 days

    Any CTCAE v5.0 Grade ≥3 event within 30 days.

Study contacts

Contact information is provided by the study sponsor or research team.

Bo Wang Professor, MD

CONTACT

[email protected]

+13959123550

Sponsors and collaborators

Lead sponsor

Fujian Medical University

Other

Registry information

Important dates

Study start
2018
Primary completion
2026
Study completion
2028
First posted
Jun 24, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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