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

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.

Study Overview

• Status: Completed
• Conditions: Differentiated Thyroid Cancer (DTC); Robotic Assistance

• Study Type: Observational
• Enrollment (Actual): 332

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200025
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
robotic modified radical neck dissection group
open modified radical neck dissection group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: RHEC-D-2021-024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No