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

NCT ID: NCT06623578

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 876 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-23
• Study Completion Date: 2033-12-31

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.

Conditions

Papillary Thyroid Carcinoma; Lymphatic Metastasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

robotic-assisted surgery

Group Type: EXPERIMENTAL

robotic-assisted surgery

Intervention Type: PROCEDURE

robotic-assisted surgery via single-incision transaxillary approach

Open Surgery

conventional treatment

Group Type: OTHER

Open Surgery

Intervention Type: PROCEDURE

conventional open surgery

Interventions

robotic-assisted surgery

robotic-assisted surgery via single-incision transaxillary approach

Intervention Type: PROCEDURE

Open Surgery

conventional open surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lin

Role: CONTACT

linpliang3@mail.sysu.edu.cn

0086-020-34071439

Facility Contacts

Peiliang Lin, M.D.

Role: primary

linpliang3@mail.sysu.edu.cn

008602034071439

Other Identifiers

SYSKY-2024-495-02

Identifier Type: -

Identifier Source: org_study_id