Actively Recruiting
Hybrid Endoscopic Hemithyroidectomy and Targeted Ablation for Bilateral Papillary Thyroid Carcinoma
Led by Fujian Medical University · Updated on 2025-07-03
60
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates a thyroid-function-preserving alternative to the usual total thyroidectomy for adults with bilateral papillary thyroid carcinoma (PTC). The study aims to confirm the cancer control and functional benefits of this approach, building on earlier results from a small patient group that showed no cancer recurrence and preserved thyroid function. It focuses on structural-recurrence-free survival, endocrine function, safety, and quality of life over a 24-month period. Participants receive a combined treatment involving remote-access, gas-less axillo-breast endoscopic hemithyroidectomy with central-neck dissection on the dominant thyroid lobe. Immediately afterward, during the same anesthesia session, ultrasound-guided radiofrequency ablation (RFA) targets a small contralateral thyroid nodule up to 7 mm. The RFA uses a 17-gauge electrode with a moving-shot technique under real-time ultrasound. During the study, participants undergo follow-up visits at 1, 6, 12, 18, and 24 months. These visits include ultrasound scans, blood tests measuring thyroid markers, calcium and parathyroid hormone levels, and quality of life questionnaires. Safety is monitored through adverse event reporting, and longer-term surveillance continues annually up to five years. The main outcomes measured are cancer recurrence-free survival and preservation of thyroid function at 24 months.
CONDITIONS
Brief Title
Hybrid Endoscopic Hemithyroidectomy and Targeted Ablation for Bilateral Papillary Thyroid Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-65 years.
- Dominant-side papillary thyroid carcinoma 1.5 cm or smaller suitable for endoscopic surgery.
- Contralateral thyroid nodule 7 mm or smaller located at least 2 mm from the posterior capsule.
- No lymph node metastasis on the contralateral side by imaging.
- Ability to provide written informed consent.
You will not qualify if you...
- Cancer spread beyond the thyroid, including gross nodal or distant metastasis.
- Previous neck surgery, prior radiofrequency ablation or ethanol injection, or neck radiation treatment.
- Current pregnancy or breastfeeding.
- Serious health conditions that prevent safe anesthesia or follow-up.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure with immediate recovery
Participants undergo endoscopic hemithyroidectomy with central-neck dissection on the dominant thyroid lobe, immediately followed by ultrasound-guided radiofrequency ablation of the contralateral thyroid nodule during the same anesthesia session.
1 day hospital visit
Duration - Up to 24 months
Participants receive follow-up assessments including ultrasound, serum thyroglobulin, calcium, parathyroid hormone, and quality of life measures to monitor recovery and thyroid function.
Follow-up visits at 1, 6, 12, 18, and 24 months
Duration - Up to 5 years
Participants continue annual surveillance assessments to monitor for structural recurrence and functional outcomes up to five years after treatment.
Annual visits
Trial Site Locations
Total: 1 location
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
Research Team
B
Bo Wang Professor, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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