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Completed

NCT Number: NCT07229859

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of retrieved Lymph nodes

    Time frame: From enrollment to the end of surgical procedure

  2. postoperative complications

    Time frame: From enrollment to the end of treatment at 1 year

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

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2025
First posted
Nov 17, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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