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

NCT07229859 | Completed

• 1 other identifier: RHEC-D-2021-024
• Study Type: observational
• Target: 332
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Differentiated Thyroid Cancer (DTC); Robotic Assistance

Outcome Measures

Primary Outcomes (2)

• Number of retrieved Lymph nodes

  From enrollment to the end of surgical procedure

• postoperative complications

  Vocal cord paralysis; hypocalcemia; spinal accessory nerve injury; chyle leakage

  From enrollment to the end of treatment at 1 year

Study Arms (2)

robotic modified radical neck dissection group

open modified radical neck dissection group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population came from a single high-volume thyroid center, with all surgeries performed by the same surgeon.

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: January 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: January 1, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-10

Locations

CN (1)