Hybrid endoscopic hemithyroidectomy plus targeted radiofrequency ablation for bilateral papillary thyroid cancer
Hybrid Endoscopic Hemithyroidectomy and Targeted Ablation for Bilateral Papillary Thyroid Carcinoma
It will test whether removing the larger tumor with a gas-less axillo-breast endoscopic hemithyroidectomy and treating a small opposite-side tumor with same-session radiofrequency ablation preserves thyroid function and controls cancer in adults with bilateral papillary thyroid carcinoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Fujian Medical University Academic / other |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT07033572 on ClinicalTrials.gov |
What this trial studies
This multicenter registry tests a thyroid-function-preserving alternative to routine total thyroidectomy for adults with bilateral papillary thyroid carcinoma. Eligible patients undergo a remote-access gas-less axillo-breast endoscopic hemithyroidectomy with level VI central-neck dissection on the dominant side, followed during the same anesthesia by ultrasound-guided radiofrequency ablation of a contralateral focus ≤7 mm. Outcomes over 24 months include structural-recurrence-free survival, endocrine-function preservation (thyroid hormone independence), safety (recurrent laryngeal nerve injury, hypocalcemia), and quality of life with scheduled ultrasound and serum Tg, calcium, and PTH checks. The registry builds on a pilot cohort of 11 patients that showed no structural recurrence and preserved endocrine function after a median 17-month follow-up.
Who should consider this trial
Good fit: Adults 18–65 with a dominant papillary thyroid carcinoma ≤1.5 cm suitable for endoscopic resection and a contralateral nodule ≤7 mm located ≥2 mm from the posterior capsule, with no contralateral radiologic lymph-node metastasis and medically fit for anesthesia.
Not a fit: Patients with extrathyroidal extension, gross nodal or distant metastasis, prior neck surgery or irradiation, pregnancy, or serious comorbidities are excluded and unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could let selected patients avoid total thyroidectomy and lifelong thyroid hormone replacement while maintaining cancer control.
How similar studies have performed: A single-center pilot cohort of 11 patients (median 17 months follow-up) reported no structural recurrences, no permanent recurrent laryngeal nerve palsy, and preserved endocrine function, but this combined endoscopic-plus-RFA strategy is not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Fuzhou, Fujian
- Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Principal investigator: Bo Wang MD, Principal Investigator — Fujian Medical University Union Hospital
- Study coordinator: Bo Wang Professor, MD
- Email: wangbo@fjmu.edu.cn
- Phone: +13959123550
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.