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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07229859
Enrollment
332
Registered
2025-11-17
Start date
2018-01-01
Completion date
2025-01-01
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Differentiated Thyroid Cancer (DTC), Robotic Assistance

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.

Interventions

None listed

Sponsors

Ruijin Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of retrieved Lymph nodesFrom enrollment to the end of surgical procedure
postoperative complicationsFrom enrollment to the end of treatment at 1 yearVocal cord paralysis; hypocalcemia; spinal accessory nerve injury; chyle leakage

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026