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Hybrid Endoscopic Hemithyroidectomy and Targeted Ablation for Bilateral Papillary Thyroid Carcinoma

ConditionsThyroid NeoplasmsCarcinoma, Papillary
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFujian Medical University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • Endoscopic Hemithyroidectomy with Central-Neck Dissection

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Hybrid Endoscopic Hemithyroidectomy + Same-Session Contralateral RFAExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Structural Recurrence-Free Survival

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

Time frame
24 months
2

Endocrine-Function Preservation

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

Time frame
24 months

Secondary outcomes

1

Permanent RLN Palsy Incidence

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

Time frame
12 months
2

Permanent Hypocalcemia Incidence

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

Time frame
12 months
3

Nodule Volume Reduction Rate

Percentage reduction of ablated nodule volume on ultrasound.

Time frame
12 months
4

Procedure-Related Adverse Events

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

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Medical University

Lead sponsor

Source ClinicalTrials.gov
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