Transaxillary robotic thyroidectomy with modified radical neck dissection versus conventional open surgery for papillary thyroid cancer with lateral lymph node spread
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 876 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06623578 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Guangzhou, Guangdong
- Sun Yat-sen Memorial Hospital — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Lin
- Email: linpliang3@mail.sysu.edu.cn
- Phone: 0086-020-34071439
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.