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

Not Applicable

Not yet recruiting

• Conditions: Papillary Thyroid Carcinoma; Lymphatic Metastasis
• Interventions: Procedure: robotic-assisted surgery; Procedure: Open Surgery

• Registration Number: NCT06623578
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-20
• Study Start: 2024-09-25
• Study First Submitted QC: 2024-09-29
• Last Update Submitted: 2024-09-29
• Study First Posted: 2024-10-02
• Last Update Posted: 2024-10-02
• Primary Completion: 2033-12-31
• Study Completion: 2033-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 876

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
robotic-assisted surgery	robotic-assisted surgery	-
Open Surgery	Open Surgery	conventional treatment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Overall survival（OS）	60 months	The time from randomization to death from any cause
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.
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.
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 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.