Transaxillary robotic thyroidectomy with modified radical neck dissection versus conventional open surgery for papillary thyroid cancer with lateral lymph node spread
Official title: 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: a Prospective Multicenter Randomized Controlled Study
Run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · NCT06623578 · Data updated 2026-11-12
This trial tests whether a transaxillary robotic thyroidectomy with modified radical neck dissection can provide similar cancer control but better cosmetic results and recovery than conventional open surgery for adults with papillary thyroid cancer that has spread to nearby neck lymph nodes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 876 (estimated) |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | September 23, 2024 |
| Main results expected | December 31, 2033 |
| Study ends | December 31, 2033 |
| Registry record updated | December 3, 2025 |
| Trial ID | NCT06623578 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–70 with papillary thyroid carcinoma, ipsilateral lateral cervical lymph node metastasis confirmed by fine-needle aspiration, tumor less than 3.0 cm, and no evidence of extrathyroidal extension are ideal candidates.
✕Probably not a fit
Patients with level I or contralateral neck node metastases, enlarged or infiltrative nodes over 2.0 cm, distant metastases, prior neck surgery or radiation, major organ failure, or intolerance to general anesthesia are excluded and unlikely to benefit from the robotic approach in this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This comparative interventional study enrolls adults with papillary thyroid carcinoma and ipsilateral lateral cervical lymph node metastasis to receive either a transaxillary robotic thyroidectomy with modified radical neck dissection or conventional open surgery. Eligible patients are 18–70 years old with tumors under 3.0 cm and no extrathyroidal extension by imaging, and surgeons will follow standardized operative and perioperative protocols. Outcomes will include oncologic measures (lymph node clearance, recurrence), surgical complications, cosmetic outcomes, and postoperative quality of life, tracked during inpatient recovery and scheduled follow-up visits. All procedures are performed at Sun Yat-sen Memorial Hospital with long-term follow-up to compare safety and effectiveness between approaches.
Why it matters
Potential benefit: If successful, the robotic transaxillary approach could offer comparable cancer control with smaller or hidden scars and improved postoperative quality of life.
How similar studies have gone: Previous studies of endoscopy-assisted external cervical approaches have reported similar oncologic outcomes and better cosmetic results compared with open surgery, but transaxillary robotic modified radical neck dissection is less widely studied and remains relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-70 years old, male or female; * papillary thyroid carcinoma with ipsilateral lateral cervical lymph node metastasis confirmed by FNAB; * thyroid tumor of less than 3.0 cm in the largest diameter; * lack of extrathyroidal extensions as estimated by preoperative ultrasonography and CT. Exclusion Criteria: * level I or contralateral neck node metastases. * enlarged lymph node of larger than 2.0 cm in the short diameter. * suspected perinodal infiltration of metastatic lymph nodes. * cervical or/and thoracic deformity. * life-threatening diseases of liver, kidney, heart and other organs, or abnormal coagulation function. * clinical evidence of distant metastases such as in the lung, bone, and so on. * history of previous neck surgery and/or radiation therapy. * intolerable to general anesthesia * refuse either surgical procedure * unwilling to cooperate with long-term follow-up evaluation.
Where it's running
-
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Lin
- Email: linpliang3@mail.sysu.edu.cn
- Phone: 0086-020-34071439
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.