Thyroid CancerNCT06793579
Lateral Approach for Mediastinal Lymph Node Dissection in Thyroid Cancer
An observational study of Thyroid Cancer and Mediastinal Diseases, run by Chongqing General Hospital at 1 site in China.
Trial summary
Despite the numerous surgical approaches available for superior mediastinal lymph node dissection in thyroid cancer, many of these methods still have significant limitations. In this study, we report for the first time a novel surgical technique for superior mediastinal lymph node dissection: a thyroid cancer surgery… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Cancer, Mediastinal Diseases, Lymph Node Metastasis
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 20 Jan 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The subjects of this retrospective study were all patients in our department who underwent treatment with this surgical approach during the inclusion period.
Who may be able to join
- All patients who underwent thyroid cancer superior mediastinal lymph node dissection via the lateral cervical approach in our department.
- Complete hospitalization records, ensuring that the patient's surgical records, pathological examinations, and other information are fully traceable.
- Complete postoperative follow-up data, including complications during the follow-up period.
- No other severe comorbidities, to avoid surgical outcome bias caused by other diseases.
- No distant metastasis found preoperatively, or distant metastasis is still assessable for effective treatment.
Who cannot join
- Cases with incomplete data, such as missing hospitalization records or incomplete follow-up data.
- Systemic diseases with severe heart, lung, liver, kidney, or brain dysfunction that may affect the accuracy of data.
- Patients with severe coagulopathy.
- Tumor pathology indicating undifferentiated thyroid cancer, malignant lymphoma, or non-thyroid-origin tumors.
Trial locations and contacts
1 site in 1 country.
China1 site
Chongqing General Hospital
Chongqing, Chongqing Municipality, 400000
About this study
Official title: Thyroid Cancer Superior Mediastinal Lymph Node Dissection Via Lateral Cervical Approach: Exploration and Practice of a Novel Surgical Pathway
Despite the numerous surgical approaches available for superior mediastinal lymph node dissection in thyroid cancer, many of these methods still have significant limitations. In this study, we report for the first time a novel surgical technique for superior mediastinal lymph node dissection: a thyroid cancer surgery based on a lateral cervical approach. This technique offers a new surgical option for the dissection of superior mediastinal lymph nodes in thyroid cancer.
Read the detailed description
The incidence of thyroid cancer has been steadily rising over the past several decades, making it a significant focus of clinical and scientific research. Superior mediastinal lymph node metastasis, as a regional manifestation of thyroid cancer metastasis, is a clinically relevant yet underexplored phenomenon. According to previous studies, the incidence of superior mediastinal lymph node metastasis in papillary thyroid carcinoma (PTC) is approximately 6% to 12%, while in medullary thyroid carcinoma (MTC), this rate is notably higher, reaching up to 18%. Although rarer, follicular thyroid carcinoma (FTC) and anaplastic thyroid carcinoma (ATC) can also involve superior mediastinal lymph node metastasis. Despite the clinical significance of this type of metastasis, international research on its surgical management remains limited, and there is currently no standardized treatment protocol for superior mediastinal lymph node dissection in thyroid cancer patients.
At present, there are four commonly utilized surgical approaches for superior mediastinal lymph node dissection in thyroid cancer: open surgery via a cervical incision, endoscopic surgery through a cervical approach, thoracoscopic surgery, and open thoracotomy. Among these, the open surgery performed through a cervical incision is often regarded as an extension of central compartment lymph node dissection. Following the dissection of the central lymph nodes, the procedure continues downward along the trachea to remove lymph nodes situated above the right brachiocephalic artery and the left brachiocephalic vein. This approach is favored for its relatively simple learning curve, lower surgical trauma, and shorter operative time, making it a preferred method when anatomical and technical conditions allow.
However, anatomical limitations pose significant challenges to this technique. The right brachiocephalic vein lies beneath the right brachiocephalic artery, while the aortic arch are located below the left brachiocephalic vein. Even with the assistance of surgical retractors, these anatomical features often obstruct the lower portions of the lymph nodes in the superior mediastinal regions 2R and 2L, limiting surgical visibility and access. This constraint can result in incomplete lymph node dissection and, in many cases, necessitates a switch to alternative approaches such as endoscopic surgery or open thoracotomy during the procedure. Furthermore, in hospitals with limited technical expertise or surgical resources, these challenges may lead to the inability to perform superior mediastinal lymph node dissection altogether.
To address these limitations, this study seeks to propose and evaluate a novel surgical approach aimed at expanding the dissection range achievable through a cervical incision. This new technique aims to improve surgical accessibility, reduce procedural complexity, and provide a more feasible and effective option for superior mediastinal lymph node dissection in thyroid cancer. By enhancing the scope and precision of the procedure, this study aspires to contribute to the development of more standardized and widely applicable surgical strategies for the management of thyroid cancer metastasis.
- Conditions
- Thyroid Cancer, Mediastinal Diseases, Lymph Node Metastasis
- Medical subject headings
- Thyroid Neoplasms, Mediastinal Diseases, Lymphatic Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of upper mediastinal lymph nodes dissected
Postoperative pathological records
Measured: 1day
Duration of surgery
Described in the surgical record
Measured: 1day
Postoperative complications
According to the follow-up data
Measured: 1 month
Surgical blood loss
Described in the surgical record
Measured: 1day
Postoperative hospital stay
Recorded in medical records
Measured: 1week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start1 Jan 2024
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
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.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793579
- Sponsor's protocol ID
- YAN-1
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Cancer Superior Mediastinal Lymph Node Dissection Via Lateral Cervical Approach: Exploration and Practice of a Novel Surgical Pathway
- ClinicalTrials.gov ID
- NCT06793579
- Acronym / sponsor ID
- YAN-1
- Conditions
- Thyroid Cancer, Mediastinal Diseases, Lymph Node Metastasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Chongqing General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 27 Jan 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.
Despite the numerous surgical approaches available for superior mediastinal lymph node dissection in thyroid cancer, many of these methods still have significant limitations. In this study, we report for the first time a novel surgical technique for superior mediastinal lymph node dissection: a thyroid cancer surgery based on a lateral cervical approach. This technique offers a new surgical option for the dissection of superior mediastinal lymph nodes in thyroid cancer.
Detailed description
The incidence of thyroid cancer has been steadily rising over the past several decades, making it a significant focus of clinical and scientific research. Superior mediastinal lymph node metastasis, as a regional manifestation of thyroid cancer metastasis, is a clinically relevant yet underexplored phenomenon. According to previous studies, the incidence of superior mediastinal lymph node metastasis in papillary thyroid carcinoma (PTC) is approximately 6% to 12%, while in medullary thyroid carcinoma (MTC), this rate is notably higher, reaching up to 18%. Although rarer, follicular thyroid carcinoma (FTC) and anaplastic thyroid carcinoma (ATC) can also involve superior mediastinal lymph node metastasis. Despite the clinical significance of this type of metastasis, international research on its surgical management remains limited, and there is currently no standardized treatment protocol for superior mediastinal lymph node dissection in thyroid cancer patients.
At present, there are four commonly utilized surgical approaches for superior mediastinal lymph node dissection in thyroid cancer: open surgery via a cervical incision, endoscopic surgery through a cervical approach, thoracoscopic surgery, and open thoracotomy. Among these, the open surgery performed through a cervical incision is often regarded as an extension of central compartment lymph node dissection. Following the dissection of the central lymph nodes, the procedure continues downward along the trachea to remove lymph nodes situated above the right brachiocephalic artery and the left brachiocephalic vein. This approach is favored for its relatively simple learning curve, lower surgical trauma, and shorter operative time, making it a preferred method when anatomical and technical conditions allow.
However, anatomical limitations pose significant challenges to this technique. The right brachiocephalic vein lies beneath the right brachiocephalic artery, while the aortic arch are located below the left brachiocephalic vein. Even with the assistance of surgical retractors, these anatomical features often obstruct the lower portions of the lymph nodes in the superior mediastinal regions 2R and 2L, limiting surgical visibility and access. This constraint can result in incomplete lymph node dissection and, in many cases, necessitates a switch to alternative approaches such as endoscopic surgery or open thoracotomy during the procedure. Furthermore, in hospitals with limited technical expertise or surgical resources, these challenges may lead to the inability to perform superior mediastinal lymph node dissection altogether.
To address these limitations, this study seeks to propose and evaluate a novel surgical approach aimed at expanding the dissection range achievable through a cervical incision. This new technique aims to improve surgical accessibility, reduce procedural complexity, and provide a more feasible and effective option for superior mediastinal lymph node dissection in thyroid cancer. By enhancing the scope and precision of the procedure, this study aspires to contribute to the development of more standardized and widely applicable surgical strategies for the management of thyroid cancer metastasis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The subjects of this retrospective study were all patients in our department who underwent treatment with this surgical approach during the inclusion period.
Key inclusion criteria (5 listed)
- All patients who underwent thyroid cancer superior mediastinal lymph node dissection via the lateral cervical approach in our department.
- Complete hospitalization records, ensuring that the patient's surgical records, pathological examinations, and other information are fully traceable.
- Complete postoperative follow-up data, including complications during the follow-up period.
- No other severe comorbidities, to avoid surgical outcome bias caused by other diseases.
- No distant metastasis found preoperatively, or distant metastasis is still assessable for effective treatment.
Key exclusion criteria (4 listed)
- Cases with incomplete data, such as missing hospitalization records or incomplete follow-up data.
- Systemic diseases with severe heart, lung, liver, kidney, or brain dysfunction that may affect the accuracy of data.
- Patients with severe coagulopathy.
- Tumor pathology indicating undifferentiated thyroid cancer, malignant lymphoma, or non-thyroid-origin tumors.
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 upper mediastinal lymph nodes dissected
Time frame: 1day
Postoperative pathological records
Duration of surgery
Time frame: 1day
Described in the surgical record
Postoperative complications
Time frame: 1 month
According to the follow-up data
Surgical blood loss
Time frame: 1day
Described in the surgical record
Postoperative hospital stay
Time frame: 1week
Recorded in medical records
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 27 Jan 2025.
- Individual participant dataSharing planned: No
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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 Thyroid Cancer and Mediastinal Diseases, run by Chongqing General 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 5 inclusion and 4 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 27 Jan 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 upper mediastinal lymph nodes dissected (time frame: 1day). The study lists 5 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 27 Jan 2025.