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

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

NCT ID: NCT06623578

Condition: Papillary Thyroid Carcinoma
Lymphatic Metastasis

Conditions: Official terms:
Carcinoma
Neoplasm Metastasis
Thyroid Neoplasms
Thyroid Cancer, Papillary
Lymphatic Metastasis

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Procedure
Intervention name: robotic-assisted surgery
Description: robotic-assisted surgery via single-incision transaxillary approach
Arm group label: robotic-assisted surgery

Intervention type: Procedure
Intervention name: Open Surgery
Description: conventional open surgery
Arm group label: Open Surgery

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Start date: September 25, 2024

Completion date: December 31, 2033

Lead sponsor:
Agency: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class: Other

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

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06623578