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.

Study Overview

• Status: Recruiting
• Conditions: Thyroid Neoplasms; Carcinoma, Papillary
• Intervention / Treatment: Procedure: Endoscopic Hemithyroidectomy with Central-Neck Dissection; Procedure: Ultrasound-Guided Radiofrequency Ablation of Contralateral Nodule

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bo Wang Professor, MD; Phone Number: +13959123550; Email: wangbo@fjmu.edu.cn

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Medical University Union Hospital
      • Contact: Bo Wang Porfessor, MD; Phone Number: +13959123550; Email: wangbo@fjmu.edu.cn
      • Principal Investigator: Bo Wang MD, Principal Investigator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Hybrid Endoscopic Hemithyroidectomy + Same-Session Contralateral RFA; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Structural Recurrence-Free Survival	Proportion of participants without local, regional, or distant structural recurrence confirmed by imaging ± cytopathology.	24 months
Endocrine-Function Preservation	Participants alive and free from lifelong levothyroxine therapy and permanent hypocalcemia (serum Ca ≥2.1 mmol/L without supplementation).	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Permanent RLN Palsy Incidence	Laryngoscopy-confirmed vocal-fold mobility disorder persisting ≥6 months.	12 months
Permanent Hypocalcemia Incidence	Need for calcium/vit-D >6 months after surgery.	12 months
Nodule Volume Reduction Rate	Percentage reduction of ablated nodule volume on ultrasound.	12 months
Procedure-Related Adverse Events	Any CTCAE v5.0 Grade ≥3 event within 30 days.	30 days

Collaborators and Investigators

• Sponsor: Fujian Medical University
• Investigators: Principal Investigator: Bo Wang MD, Principal Investigator, Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: June 13, 2025
• First Submitted That Met QC Criteria: June 13, 2025
• First Posted (Actual): June 24, 2025

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Radiofrequency ablation; Hybrid endoscopic thyroidectomy; Thyroid function preservation; Bilateral Thyroid Carcinoma
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Neoplasms, Squamous Cell; Adenocarcinoma, Papillary; Thyroid Cancer, Papillary; Thyroid Diseases; Carcinoma; Thyroid Neoplasms; Carcinoma, Papillary
• Other Study ID Numbers: Hybrid

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No