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NCT Number: NCT06623578

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510120, China

Location status: Recruiting

Location contact

Peiliang Lin, M.D.

CONTACT

[email protected]

008602034071439

Xiaoming Huang, M.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

robotic-assisted surgery

Procedure

robotic-assisted surgery via single-incision transaxillary approach

Open Surgery

Procedure

conventional open surgery

Primary outcomes

  1. the disease-free survival rate

    Time frame: 60 months

    The 5-year survival rate without a functional, structural, or biological event

  2. 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.

Secondary outcomes

  1. Overall survival(OS)

    Time frame: 60 months

    The time from randomization to death from any cause

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2033
Study completion
2033
First posted
Oct 2, 2024
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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