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Papillary Thyroid CarcinomaNCT06623578

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

A study testing robotic-assisted surgery and Open Surgery in people with Papillary Thyroid Carcinoma and Lymphatic Metastasis, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
robotic-assisted surgery and Open Surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
876 participants
Where
1 siteChina
Study dates
23 Sep 2024to 31 Dec 2033
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lin contact

0086-020-34071439

linpliang3@mail.sysu.edu.cn

China1 site, 1 recruiting

  • Sun Yat-sen Memorial Hospital

    Guangzhou, Guangdong, 510120

    Peiliang Lin, M.D., 008602034071439, linpliang3@mail.sysu.edu.cn

    Xiaoming Huang, M.D.

    Recruiting

Other trials in China

About this study

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

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.

Being tested
robotic-assisted surgery, Open Surgery
Medical subject headings
Thyroid Cancer, Papillary, Lymphatic Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • robotic-assisted surgeryProcedure or surgery

    robotic-assisted surgery via single-incision transaxillary approach

  • Open SurgeryProcedure or surgery

    conventional open surgery

Study groups in NCT06623578
Study groupRoleWhat they receive
robotic-assisted surgeryExperimentalNot described
Receives: Procedure: robotic-assisted surgery
Open SurgeryOtherconventional treatment
Receives: Procedure: Open Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the disease-free survival rate

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

    Measured: 60 months

  2. Postoperative quality of life：36-Item Short-Form Survey

    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.

    Measured: 12 months

Secondary outcomes (7)

  1. Overall survival（OS）

    The time from randomization to death from any cause

    Measured: 60 months

  2. The dynamic change trend of shoulder function

    Shoulder function is assessed using arm abduction test (0-5) to explore the dynamic change. The higher scores mean a better outcome.

    Measured: 60 months

  3. The dynamic change trend of the postoperative quality of life

    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.

    Measured: 60 months

  4. The dynamic change of swallowing function

    Swallowing function is assessed using Swallowing Impairment Index 6 (0-24) to explore the dynamic change. The higher scores mean a worse outcome.

    Measured: 60 months

  5. The dynamic change trend of neck function

    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.

    Measured: 60 months

  6. The dynamic change trend of aesthetic satisfaction

    Aesthetic satisfaction is assessed using verbal response scale (0-10) to explore the dynamic change. The higher scores mean a better outcome.

    Measured: 60 months

  7. The dynamic change trend of voice function

    Voice function is assessed using Voice Handicap Index 10 (0-40) to explore the dynamic change. The higher scores mean a worse outcome.

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2024
  2. Study start23 Sep 2024
  3. Primary completion31 Dec 2033 (estimated)
  4. Study completion31 Dec 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
876 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06623578
Sponsor's protocol ID
SYSKY-2024-495-02
Status last verified
Nov 2025
First submitted
20 Sep 2024
Last updated
3 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing robotic-assisted surgery and Open Surgery in people with Papillary Thyroid Carcinoma and Lymphatic Metastasis, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lin (0086-020-34071439, linpliang3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the disease-free survival rate (time frame: 60 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06623578.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025; AzTrials last refreshed its copy on 30 Oct 2026.

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