Robotic Surgery Via Bilateral Axillo-breast Approach for Relatively Low-risk Papillary Thyroid Carcinoma With Lateral Cervical Lymph Node Metastasis: a Safe and Effective Cosmetic Procedure in the Context of Prevalent Thyroid Ultrasound Screening

Shanghai Jiao Tong University

Status: Completed

Conditions: Robotic Assistance; Differentiated Thyroid Cancer (DTC)

Study type: Observational

Funder types: Other

Identifiers

NCT07229859

RHEC-D-2021-024

Details and patient eligibility

About

The goal of this observational study is to learn the efficacy, cosmetic effectiveness and safety of robotic modified radical neck dissection in well-selected cases, through direct comparison with conventional open surgery in low-risk papillary thyroid carcinoma with lateral cervical lymph node metastasis. The main questions it aims to answer are:

Does robotic neck dissection provide tumor clearance equivalent to that of the conventional open approach? How does the postoperative complication rate of the robotic technique compare with open surgery? Are patients satisfied with the cosmetic appearance of the wound following robotic neck dissection? Researchers will compare robotic surgery with conventional open surgery to see if it has the same efficacy, cosmetic effectiveness and safety.

Participants' postoperative recovery will be followed up, and they will provide pain scores and rate their cosmetic satisfaction with the wound.

Enrollment: 332 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• (1) PTC with lateral LN metastasis confirmed by fine needle aspiration (FNA) biopsy;
• (2) maximum tumor size < 3 cm;
• (3) without extrathyroidal extension;
• (4) metastatic LNs in unilateral levels II, III, IV and/or V;
• (5) number of suspicious metastatic LNs based on preoperative ultrasonography < 5;
• (6) maximum metastatic LN diameter < 3 cm.

Exclusion criteria

• (1) metastatic LNs in level I or VII;
• (2) metastatic LNs fused with each other or fixed in the neck or extra-nodal extension;
• (3) history of neck surgery or radiation therapy;
• (4) extranodal extension;
• (5) the presence of TERT mutation.

Trial design

332 participants in 2 patient groups

robotic modified radical neck dissection group

open modified radical neck dissection group