Differentiated Thyroid Cancer (DTC)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
An observational study of Differentiated Thyroid Cancer (DTC) and Robotic Assistance, run by Ruijin Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Differentiated Thyroid Cancer (DTC), Robotic Assistance
- How many people
- 332 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Jan 2025
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population came from a single high-volume thyroid center, with all surgeries performed by the same surgeon.
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| robotic modified radical neck dissection group | Not described | |
| open modified radical neck dissection group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of retrieved Lymph nodes
Measured: From enrollment to the end of surgical procedure
postoperative complications
Vocal cord paralysis; hypocalcemia; spinal accessory nerve injury; chyle leakage
Measured: From enrollment to the end of treatment at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start1 Jan 2018
- Primary completion31 Dec 2022
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Differentiated Thyroid Cancer (DTC)Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 332 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229859
- Sponsor's protocol ID
- RHEC-D-2021-024
- Status last verified
- Oct 2025
- First submitted
- 13 Nov 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sun H, Zhan L, Qin X, Wang Y, Gao H, Liu Z, Zhao Q, Liao Z, Qiu W, Cai W, Yan J. Robotic surgery for papillary thyroid carcinoma with lateral cervical lymph node metastasis: a hybrid design, observational, propensity score matching cohort study. Surg Endosc. 2026 Nov 2. doi: 10.1007/s00464-026-13474-1. Online ahead of print.
PubMed 42972062
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07229859
- Acronym / sponsor ID
- RHEC-D-2021-024
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| robotic modified radical neck dissection group | – | – |
| open modified radical neck dissection group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population came from a single high-volume thyroid center, with all surgeries performed by the same surgeon.
Key inclusion criteria (6 listed)
- (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;
Key exclusion criteria (5 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of retrieved Lymph nodes
Time frame: From enrollment to the end of surgical procedure
postoperative complications
Time frame: From enrollment to the end of treatment at 1 year
Vocal cord paralysis; hypocalcemia; spinal accessory nerve injury; chyle leakage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Derived from this study: PubMed 42972062Sun H, Zhan L, Qin X, Wang Y, Gao H, Liu Z, Zhao Q, Liao Z, Qiu W, Cai W, Yan J. Robotic surgery for papillary thyroid carcinoma with lateral cervical lymph node metastasis: a hybrid design, observational, propensity score matching cohort study. Surg Endosc. 2026 Nov 2. doi: 10.1007/s00464-026-13474-1. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Differentiated Thyroid Cancer (DTC) and Robotic Assistance, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of retrieved Lymph nodes (time frame: From enrollment to the end of surgical procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07229859, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.