- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06793579
Lateral Approach for Mediastinal Lymph Node Dissection in Thyroid Cancer
Thyroid Cancer Superior Mediastinal Lymph Node Dissection Via Lateral Cervical Approach: Exploration and Practice of a Novel Surgical Pathway
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Chongqing
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Chongqing, Chongqing, China, 400000
- Chongqing General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of upper mediastinal lymph nodes dissected
Time Frame: 1day
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Postoperative pathological records
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1day
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Duration of surgery
Time Frame: 1day
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Described in the surgical record
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1day
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Postoperative complications
Time Frame: 1 month
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According to the follow-up data
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1 month
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Surgical blood loss
Time Frame: 1day
|
Described in the surgical record
|
1day
|
|
Postoperative hospital stay
Time Frame: 1week
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Recorded in medical records
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1week
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YAN-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Thyroid Cancer
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National Cancer Institute (NCI)TerminatedInsular Thyroid Cancer | Recurrent Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid Cancer | Anaplastic Thyroid Cancer | Stage III Follicular Thyroid Cancer | Stage III Papillary Thyroid CancerUnited States
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University of WashingtonNational Cancer Institute (NCI); GlaxoSmithKline; National Comprehensive Cancer...CompletedRecurrent Thyroid Cancer | Stage IVA Follicular Thyroid Cancer | Stage IVA Papillary Thyroid Cancer | Stage IVB Follicular Thyroid Cancer | Stage IVB Papillary Thyroid Cancer | Stage IVC Follicular Thyroid Cancer | Stage IVC Papillary Thyroid CancerUnited States
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National Cancer Institute (NCI)CompletedRecurrent Thyroid Cancer | Stage IVA Follicular Thyroid Cancer | Stage IVA Papillary Thyroid Cancer | Stage IVB Follicular Thyroid Cancer | Stage IVB Papillary Thyroid Cancer | Stage IVC Follicular Thyroid Cancer | Stage IVC Papillary Thyroid CancerUnited States
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University of PennsylvaniaCompletedMetastatic Medullary Thyroid Cancer | Metastatic Differentiated Thyroid Cancer | Metastatic Anaplastic Thyroid Cancer | Metastatic Poorly Differentiated Thyroid CancerUnited States
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Children's Hospital of PhiladelphiaEli Lilly and Company; United States Department of DefenseRecruitingCancer | Pediatric Cancer | Differentiated Thyroid Cancer | Cancer, ThyroidUnited States
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National Cancer Institute (NCI)CompletedInsular Thyroid Cancer | Recurrent Thyroid Cancer | Stage II Follicular Thyroid Cancer | Stage II Papillary Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid CancerUnited States
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Children's Hospital of PhiladelphiaBayerRecruitingCancer | Pediatric Cancer | Differentiated Thyroid Cancer | Cancer, ThyroidUnited States
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Massachusetts General HospitalEli Lilly and CompanyRecruitingThyroid Carcinoma | Thyroid Cancer | Papillary Thyroid Cancer | Metastatic Thyroid Cancer | Follicular Thyroid Cancer | Unresectable Thyroid Gland CarcinomaUnited States
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H. Lee Moffitt Cancer Center and Research InstituteTerminatedThyroid Cancer, Medullary | Thyroid Cancer | Papillary Thyroid Cancer | Differentiated Thyroid Cancer | Poorly Differentiated Thyroid Gland Carcinoma | Follicular Thyroid CancerUnited States
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National Cancer Institute (NCI)CompletedRecurrent Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid CancerUnited States