Actively Recruiting
Preserving Function Integrity of Neck Anatomy in Thyroid Surgery: A Randomized Clinical Trial
Led by Wuhan University · Updated on 2020-12-14
1264
Participants Needed
1
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial focuses on patients with low-risk papillary thyroid carcinoma who also have a benign nodule on the opposite side of the thyroid. It explores whether routine total thyroid removal is necessary, as lobectomy alone may be sufficient. The study addresses concerns about anxiety related to residual benign nodules and evaluates an alternative approach using intraoperative thermal ablation to treat these nodules after lobectomy. This approach has shown benefits in quality of life with manageable complication rates. Participants undergo thyroid lobectomy using a precise surgical technique that preserves important neck structures like the parathyroid glands. After removing the affected thyroid lobe and performing neck dissection, the benign nodule on the opposite side is treated with thermal ablation using a special hydrodissection technique. This method helps protect critical nerves and tissues from heat damage during the procedure. The trial compares standard lobectomy alone to lobectomy combined with this thermal ablation treatment. Throughout the study, participants will be monitored for complications over two years and assessed for anxiety, fear of disease progression, and thyroid cancer-specific quality of life up to six months after treatment. Additionally, the rate of cancer recurrence will be evaluated with a five-year follow-up. The study aims to understand both the safety and psychological impact of adding thermal ablation to thyroid lobectomy over an extended observation period.
CONDITIONS
Brief Title
Function Integrity of Neck Anatomy in Thyroid Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with unilateral thyroid carcinoma and contralateral benign nodule confirmed by preoperative ultrasound-guided fine-needle aspiration cytology
- Patients with contralateral nodules �3C= 20mm and located in the thyroid gland
- Patients with clinical node-negative cervical compartment at palpation and neck ultrasound
You will not qualify if you...
- Previous history of neck surgery
- Previous history of neck radiation therapy
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo thyroid lobectomy surgery. Some participants also receive intraoperative thermal ablation of the contralateral benign thyroid nodule during surgery using a hydrodissection technique to protect important neck structures.
1 surgical visit (in-person)
Duration - Up to 5 years
Participants are monitored for surgical complications, anxiety, depression, quality of life, and recurrence of disease after surgery.
Multiple follow-up visits up to 6 months and longer-term assessments up to 5 years
Trial Site Locations
Total: 1 location
1
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430071
Actively Recruiting
Research Team
Q
Qianqian Yuan, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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