Lymphatic Metastasis, Papillary Thyroid Carcinoma
Conditions
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.
Interventions
PROCEDURErobotic-assisted surgery
robotic-assisted surgery via single-incision transaxillary approach
PROCEDUREOpen Surgery
conventional open surgery
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the disease-free survival rate | 60 months | The 5-year survival rate without a functional, structural, or biological event |
| Postoperative quality of life：36-Item Short-Form Survey | 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
| Measure | Time frame | Description |
|---|---|---|
| The dynamic change trend of the postoperative quality of life | 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. |
| The dynamic change of swallowing function | 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. |
| Overall survival（OS） | 60 months | The time from randomization to death from any cause |
| The dynamic change trend of aesthetic satisfaction | 60 months | Aesthetic satisfaction is assessed using verbal response scale (0-10) to explore the dynamic change. The higher scores mean a better outcome. |
| The dynamic change trend of voice function | 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. |
| The dynamic change trend of neck function | 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. |
| The dynamic change trend of shoulder function | 60 months | Shoulder function is assessed using arm abduction test (0-5) to explore the dynamic change. The higher scores mean a better outcome. |
Countries
China
Contacts
Primary ContactLin
Outcome results
None listed