RecruitingNot ApplicableNCT07033572

Hybrid Endoscopic Hemithyroidectomy and Targeted Ablation for Bilateral Papillary Thyroid Carcinoma


Sponsor

Fujian Medical University

Enrollment

60 participants

Start Date

Jun 1, 2018

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

  • 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 Criteria4

  • 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.

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.


Locations(1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

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NCT07033572


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