Comparative Study of Transaxillary Robotic Thyroidectomy With MRND Versus Conventional Open Surgery in N1b PTC

November 25, 2025 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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

Thyroid cancer is one of the most common malignant tumors in women, ranking seventh in the United States and fourth in China. Papillary thyroid carcinoma is the most common pathological type (about 85% to 90% of thyroid cancers), and lateral cervical lymph node metastasis can reach 0.6-37.5% at diagnosis. For papillary thyroid cancer with lateral cervical lymph node metastasis, the 2015 ATA Guidelines in the United States recommend surgical resection and neck lymph node dissection as the primary treatment. Traditional cervical lymph node dissection often leaves obvious scars in the neck, which seriously affects the postoperative quality of life of patients. The previous studies have shown that endoscopy-assisted surgery with external cervical approach can achieve oncologic effects similar to traditional open surgery in the treatment of N1b papillary thyroid cancer, and can obtain better aesthetic results. However, endoscopic surgery still has some shortcomings, such as poor exposure of some surgical areas and difficult operation. Since November 2016, the investigators tried to apply modified transaxillary robotic-assisted surgery technology to the treatment of thyroid papillary carcinoma in China. The preliminary study included 30 patients, and the results showed that robot-assisted surgery via combined transaxillary-retroaural approach in the treatment of N1b papillary thyroid carcinoma achieved a good oncologic effect (5-year overall survival rate was 100.0%). As the surgical techniques improved, now the investigators can complete robotic-assisted lateral neck lymph node dissection via single-incision transaxillary approach. However, there is still a lack of high-quality evidence on the long-term oncologic outcome and quality of life of this procedure. In this study, a prospective, multi-center, randomized controlled study was conducted to compare the safety, long-term oncologic outcomes and postoperative quality of life of the robot-assisted surgery via single-incision transaxillary approach and open surgery in the treatment of N1b papillary thyroid cancer, which may provide an alternative for the patients with N1b papillary thyroid cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

876

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Sun Yat-sen Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Xiaoming Huang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: robotic-assisted surgery
Procedure: robotic-assisted surgery
robotic-assisted surgery via single-incision transaxillary approach
Other: Open Surgery
conventional treatment
Procedure: Open Surgery
conventional open surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the disease-free survival rate
Time Frame: 60 months
The 5-year survival rate without a functional, structural, or biological event
60 months
Postoperative quality of life：36-Item Short-Form Survey
Time Frame: 12 months
The quality of life is assessed by 36-Item Short-Form Survey (SF-36) 1 year after surgery, and the differences in physical and physiological dimensions between the two groups were compared. The higher scores mean a better outcome.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival（OS）
Time Frame: 60 months
The time from randomization to death from any cause
60 months
The dynamic change trend of shoulder function
Time Frame: 60 months
Shoulder function is assessed using arm abduction test (0-5) to explore the dynamic change. The higher scores mean a better outcome.
60 months
The dynamic change trend of the postoperative quality of life
Time Frame: 60 months
The postoperative quality of life is assessed using 36-Item Short-Form Survey to explore the dynamic change. The higher scores mean a better outcome.
60 months
The dynamic change of swallowing function
Time Frame: 60 months
Swallowing function is assessed using Swallowing Impairment Index 6 (0-24) to explore the dynamic change. The higher scores mean a worse outcome.
60 months
The dynamic change trend of neck function
Time Frame: 60 months
Neck function is assessed using Ten-item Neck Dissection Impairment Index (0-100) to explore the dynamic change. The higher scores mean a better outcome.
60 months
The dynamic change trend of aesthetic satisfaction
Time Frame: 60 months
Aesthetic satisfaction is assessed using verbal response scale (0-10) to explore the dynamic change. The higher scores mean a better outcome.
60 months
The dynamic change trend of voice function
Time Frame: 60 months
Voice function is assessed using Voice Handicap Index 10 (0-40) to explore the dynamic change. The higher scores mean a worse outcome.
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2024

Primary Completion (Estimated)

December 31, 2033

Study Completion (Estimated)

December 31, 2033

Study Registration Dates

First Submitted

September 20, 2024

First Submitted That Met QC Criteria

September 29, 2024

First Posted (Actual)

October 2, 2024

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSKY-2024-495-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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