Thyroid CancerNCT07654322
Clinical Study on the Efficacy of Laparoscopic Assisted Open Surgery Through Subclavian Approach for Unilateral Thyroid Cancer
An observational study of Thyroid Cancer, run by Xijing Hospital.
Trial summary
This study compares the clinical efficacy of non inflatable subclavian endoscopic surgery and open surgery for unilateral thyroid cancer, aiming to compare the differences in lymph node dissection rate, complication rate, surgical time, hospitalization time, drainage tube placement time and other indicators between… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thyroid Cancer
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 28 Feb 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: According to the latest ATA guidelines for the diagnosis and treatment of thyroid nodules and thyroid cancer in China, papillary thyroid carcinoma confirmed by histopathology has a clinical staging of cN0 in cervical lymph nodes. The patient has unilateral thyroid cancer with T1-T2 stage tumors, no lymph node metastasis, no extraglandular invasion, and no distant metastasis. They are willing to undergo surgical treatment for thyroid cancer
Who may be able to join
- Patients with newly diagnosed thyroid cancer aged ≥ 18 years and ≤ 70 years old;
- According to the latest ATA guidelines for the diagnosis and treatment of thyroid nodules and thyroid cancer in China, papillary thyroid carcinoma confirmed by histopathology has a clinical staging of cN0 in cervical lymph nodes.
- The patient has unilateral thyroid cancer with T1-T2 stage tumors, no lymph node metastasis, no extraglandular invasion, and no distant metastasis. They are willing to undergo surgical treatment for thyroid cancer;
- The surgical method is determined through joint consultation between the patient and the doctor;
- Participants voluntarily join this study and sign an informed consent form.
Who cannot join
- Age>70 years old;
- Initial diagnosis of stage III-IV thyroid cancer;
- Thyroid cancer accompanied by abnormal thyroid function;
- The heart, lung, liver, kidney and other important organs have abnormal functions, and diabetes with poor control cannot tolerate surgery;
- The researcher believes that the patient is not suitable to participate in any other circumstances of this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Multicenter Prospective Cohort Clinical Study on the Efficacy of Pneumoperitoneum-Free, Subclavian Transaxillary Laparoscopic-Assisted Versus Open Surgery for Unilateral Thyroid Cancer
This study compares the clinical efficacy of non inflatable subclavian endoscopic surgery and open surgery for unilateral thyroid cancer, aiming to compare the differences in lymph node dissection rate, complication rate, surgical time, hospitalization time, drainage tube placement time and other indicators between the two surgical procedures, and provide guidance for surgical selection and safety in the later stage.
This study is a clinical controlled trial that plans to include 400 consecutive patients with thyroid cancer. After being fully informed and signing the informed consent form, the subjects will enter the trial period after being screened and qualified. The subjects will undergo non inflatable subclavian endoscopic thyroidectomy or open subclavian thyroidectomy according to their own wishes. The enrollment period is from March 2026-2028. The follow-up period should be at least 5 years.
Read more
After the start of the experiment, a recruitment notice and corresponding recruitment manual will be issued, with a planned recruitment of 100 patients. The preparation stage for clinical research should include the preparation, distribution, and confirmation of research documents, as well as personnel training; Sign the informed consent form and screen the subjects. The surgical method for thyroid cancer is determined by the surgeon based on the patient's condition and after communication with the patient Evaluate the number of lymph nodes and metastatic lymph nodes in the central area by the pathology department, organize the operation time according to the surgical records, calculate the patient's drainage volume and hospitalization time according to the nursing records, and conduct telephone follow-up on patient satisfaction in the later stage.
Establish individual patient information using the existing thyroid cancer database in the department, recording general information, diagnosis and treatment history, and other relevant data.
- Conditions
- Thyroid Cancer
- Medical subject headings
- Thyroid Neoplasms
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 |
|---|---|---|
| Endoscopic assisted surgery | Not described | |
| Conventional open surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complications
The short-term complication rate of surgery in subjects includes postoperative infection, postoperative bleeding, temporary recurrent laryngeal nerve injury, superior laryngeal nerve injury, and temporary hypocalcemia or hypoparathyroidism; the long-term complication rate includes permanent recurrent laryngeal nerve injury and permanent hypocalcemia or hypoparathyroidism.
Measured: The observation period is at least 3 years from the start of enrollment
patient satisfaction
The assessment was conducted using the Patient Scar Assessment Questionnaire (PSAQ). This questionnaire comprises four valid subscales (totaling 29 items): Scar Appearance (10 items, scoring range 9-36), Scar-Related Self-Consciousness (6 items, scoring range 6-24), Satisfaction with Appearance (8 items, scoring range 8-32), and Satisfaction with Symptoms (5 items, scoring range 5-20). Each item is scored using a four-point categorical response scale (1=most favorable, 4=least favorable). A higher total score indicates more severe scar-related issues or lower satisfaction.
Measured: The assessment was conducted at 6, 12, and 24 months post-surgery
Secondary outcomes (1)
Disease-free-survival
The duration from the subject's enrollment to the first occurrence of recurrent disease, which includes ipsilateral lymph node recurrence, local or regional recurrence, distant recurrence, and death from any cause.
Measured: The observation period is at least 3 years from the start of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Xijing 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654322
- Sponsor's protocol ID
- XJYY-LL-FJ-029
- Other IDs
- 82303359, S2021-YF-YBSF-0258
- Status last verified
- Jan 2026
- First submitted
- 23 Feb 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Cohort Clinical Study on the Efficacy of Pneumoperitoneum-Free, Subclavian Transaxillary Laparoscopic-Assisted Versus Open Surgery for Unilateral Thyroid Cancer
- ClinicalTrials.gov ID
- NCT07654322
- Acronym / sponsor ID
- XJYY-LL-FJ-029
- Conditions
- Thyroid Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2031 (estimated)
- First posted
- 17 Jun 2026 (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.
This study compares the clinical efficacy of non inflatable subclavian endoscopic surgery and open surgery for unilateral thyroid cancer, aiming to compare the differences in lymph node dissection rate, complication rate, surgical time, hospitalization time, drainage tube placement time and other indicators between the two surgical procedures, and provide guidance for surgical selection and safety in the later stage.
This study is a clinical controlled trial that plans to include 400 consecutive patients with thyroid cancer. After being fully informed and signing the informed consent form, the subjects will enter the trial period after being screened and qualified. The subjects will undergo non inflatable subclavian endoscopic thyroidectomy or open subclavian thyroidectomy according to their own wishes. The enrollment period is from March 2026-2028. The follow-up period should be at least 5 years.
After the start of the experiment, a recruitment notice and corresponding recruitment manual will be issued, with a planned recruitment of 100 patients. The preparation stage for clinical research should include the preparation, distribution, and confirmation of research documents, as well as personnel training; Sign the informed consent form and screen the subjects. The surgical method for thyroid cancer is determined by the surgeon based on the patient's condition and after communication with the patient Evaluate the number of lymph nodes and metastatic lymph nodes in the central area by the pathology department, organize the operation time according to the surgical records, calculate the patient's drainage volume and hospitalization time according to the nursing records, and conduct telephone follow-up on patient satisfaction in the later stage.
Establish individual patient information using the existing thyroid cancer database in the department, recording general information, diagnosis and treatment history, and other relevant data.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic assisted surgery | – | – |
| Conventional open surgery | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- According to the latest ATA guidelines for the diagnosis and treatment of thyroid nodules and thyroid cancer in China, papillary thyroid carcinoma confirmed by histopathology has a clinical staging of cN0 in cervical lymph nodes. The patient has unilateral thyroid cancer with T1-T2 stage tumors, no lymph node metastasis, no extraglandular invasion, and no distant metastasis. They are willing to undergo surgical treatment for thyroid cancer
Key inclusion criteria (5 listed)
- Patients with newly diagnosed thyroid cancer aged ≥ 18 years and ≤ 70 years old;
- According to the latest ATA guidelines for the diagnosis and treatment of thyroid nodules and thyroid cancer in China, papillary thyroid carcinoma confirmed by histopathology has a clinical staging of cN0 in cervical lymph nodes.
- The patient has unilateral thyroid cancer with T1-T2 stage tumors, no lymph node metastasis, no extraglandular invasion, and no distant metastasis. They are willing to undergo surgical treatment for thyroid cancer;
- The surgical method is determined through joint consultation between the patient and the doctor;
- Participants voluntarily join this study and sign an informed consent form.
Key exclusion criteria (5 listed)
- Age>70 years old;
- Initial diagnosis of stage III-IV thyroid cancer;
- Thyroid cancer accompanied by abnormal thyroid function;
- The heart, lung, liver, kidney and other important organs have abnormal functions, and diabetes with poor control cannot tolerate surgery;
- The researcher believes that the patient is not suitable to participate in any other circumstances of this study.
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
Incidence of complications
Time frame: The observation period is at least 3 years from the start of enrollment
The short-term complication rate of surgery in subjects includes postoperative infection, postoperative bleeding, temporary recurrent laryngeal nerve injury, superior laryngeal nerve injury, and temporary hypocalcemia or hypoparathyroidism; the long-term complication rate includes permanent recurrent laryngeal nerve injury and permanent hypocalcemia or hypoparathyroidism.
patient satisfaction
Time frame: The assessment was conducted at 6, 12, and 24 months post-surgery
The assessment was conducted using the Patient Scar Assessment Questionnaire (PSAQ). This questionnaire comprises four valid subscales (totaling 29 items): Scar Appearance (10 items, scoring range 9-36), Scar-Related Self-Consciousness (6 items, scoring range 6-24), Satisfaction with Appearance (8 items, scoring range 8-32), and Satisfaction with Symptoms (5 items, scoring range 5-20). Each item is scored using a four-point categorical response scale (1=most favorable, 4=least favorable). A higher total score indicates more severe scar-related issues or lower satisfaction.
1 secondary outcome
Disease-free-survival
Time frame: The observation period is at least 3 years from the start of enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer, run by Xijing Hospital.
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 5 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: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juliang Zhang (86+18792998965, 408123913@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of complications (time frame: The observation period is at least 3 years from the start of enrollment). 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?
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 Jun 2026.