Comparative Study of Transaxillary Robotic Thyroidectomy With MRND Versus Conventional Open Surgery in N1b PTC
1 other identifier
interventional
876
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2024
CompletedStudy Start
First participant enrolled
September 23, 2024
CompletedFirst Posted
Study publicly available on registry
October 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2033
December 3, 2025
November 1, 2025
9.3 years
September 20, 2024
November 25, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
the disease-free survival rate
The 5-year survival rate without a functional, structural, or biological event
60 months
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.
12 months
Secondary Outcomes (7)
Overall survival（OS）
60 months
The dynamic change trend of shoulder function
60 months
The dynamic change trend of the postoperative quality of life
60 months
The dynamic change of swallowing function
60 months
The dynamic change trend of neck function
60 months
- +2 more secondary outcomes
Study Arms (2)
robotic-assisted surgery
EXPERIMENTALOpen Surgery
OTHERconventional treatment
Interventions
robotic-assisted surgery via single-incision transaxillary approach
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510120, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2024
First Posted
October 2, 2024
Study Start
September 23, 2024
Primary Completion (Estimated)
December 31, 2033
Study Completion (Estimated)
December 31, 2033
Last Updated
December 3, 2025
Record last verified: 2025-11