Actively Recruiting
Comparative Study of Transaxillary Robotic Thyroidectomy With Modified Radical Neck Dissection Versus Conventional Open Surgery in Patients With Papillary Thyroid Carcinoma and Lateral Neck Node Metastases
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-12-03
876
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Papillary thyroid carcinoma, the most common type of thyroid cancer, often involves lateral neck lymph node metastasis. This trial investigates the safety, long-term cancer control, and quality of life after two surgical treatments for patients with N1b papillary thyroid cancer: robotic-assisted surgery via a single-incision transaxillary approach versus traditional open surgery. The goal is to provide evidence on whether the newer robotic method can offer similar cancer outcomes with improved cosmetic results and quality of life. Participants will be randomly assigned to receive either the robotic-assisted surgery using a single incision through the armpit or conventional open surgery with neck lymph node dissection. This prospective, multicenter randomized controlled study compares these two surgical approaches in treating papillary thyroid cancer with lateral neck metastases. The robotic surgery technique aims to reduce visible neck scars while maintaining cancer control. During the study, participants will be followed for up to 60 months to measure disease-free survival and overall survival rates. Quality of life will be assessed at 12 months and monitored over 60 months, including shoulder function, swallowing, neck movement, voice, and aesthetic satisfaction. Researchers will also evaluate long-term safety and functional outcomes. The study is sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University and includes adults aged 18 to 70 years with confirmed papillary thyroid cancer and lateral neck lymph node involvement.
CONDITIONS
Brief Title
Comparative Study of Transaxillary Robotic Thyroidectomy With MRND Versus Conventional Open Surgery in N1b PTC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years old, male or female
- Papillary thyroid carcinoma with ipsilateral lateral cervical lymph node metastasis confirmed by fine needle aspiration biopsy
- Thyroid tumor smaller than 3.0 cm in largest diameter
- No extrathyroidal extension as estimated by preoperative ultrasound and CT
You will not qualify if you...
- Level I or contralateral neck node metastases
- Enlarged lymph node larger than 2.0 cm in short diameter
- Suspected perinodal infiltration of metastatic lymph nodes
- Cervical and/or thoracic deformity
- Life-threatening diseases of liver, kidney, heart, or other organs, or abnormal blood clotting function
- Clinical evidence of distant metastases such as lung or bone
- History of previous neck surgery and/or radiation therapy
- Intolerant to general anesthesia
- Refusal of either surgical procedure
- Unwillingness to cooperate with long-term follow-up evaluation
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 - Hospital stay duration as per clinical practice
Participants undergo either transaxillary robotic thyroidectomy with modified radical neck dissection or conventional open surgery, followed by immediate post-operative care.
1 surgery visit (in-person) and immediate post-operative assessments
Duration - Up to 60 months
Participants are monitored for recovery, functional outcomes, and quality of life after surgery.
Regular follow-up visits over 60 months
Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China, 510120
Actively Recruiting
Research Team
L
Lin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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