Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID06623578

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

On this page

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

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

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

Post-operative Follow-up

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

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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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