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

NCT ID: NCT07229859

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

332 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2025-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Differentiated Thyroid Cancer (DTC) Robotic Assistance

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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robotic modified radical neck dissection group

No interventions assigned to this group

open modified radical neck dissection group

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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RHEC-D-2021-024

Identifier Type: -

Identifier Source: org_study_id

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