Lateral Neck Lymph Node Mapping in Thyroid Cancer

Study Overview
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Brief Summary
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This study includes papillary thyroid cancer patients who have unpalpable lateral neck lymph nodes but suspicious on ultrasound and/or CT. Carbon nanoparticles is used as the tracer for lateral neck lymph node mapping.

Official Title
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Lateral Neck Lymph Node Mapping in Papillary Thyroid Carcinoma

Conditions
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Thyroid Cancer

Intervention / Treatment
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* Procedure: Lateral neck sentinel lymph node biopsy
* Procedure: Modified lateral neck lymph node dissection
* Procedure: Super selective lateral neck lymph node dissection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed papillary thyroid cancer The maximum diameter of the thyroid cancer <3 cm with enough normal thyroid tissue for tracer injection Unpalpable lateral neck lymph nodes Ultrasound and CT showed suspected lateral neck lymph nodes <2 cm Exclusion Criteria: Previously treated thyroid cancer High risk thyroid cancer (e.g. with severe extra-adenial invasion or extensive lymph node metastasis or poorly differentiated thyroid cancer) Patients with distant metastasis

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MLND<br>Modified lateral neck dissection (compartment II-V) is performed in all patients. | Procedure: Modified lateral neck lymph node dissection<br>* Modified lateral neck dissection (compartment II-V) is performed in all patients in Arm A, and some of the patients in Arm B (according to sentinel lymph node biopsy results).<br>|
| Experimental: SLNB<br>Sentinel lymph node biopsy in the lateral neck is performed. The decision of neck dissection is based on the result of sentinel lymph node biopsy. | Procedure: Lateral neck sentinel lymph node biopsy<br>* Lateral neck sentinel lymph node biopsy is performed in all patients in Arm B.<br>Procedure: Modified lateral neck lymph node dissection<br>* Modified lateral neck dissection (compartment II-V) is performed in all patients in Arm A, and some of the patients in Arm B (according to sentinel lymph node biopsy results).<br>Procedure: Super selective lateral neck lymph node dissection<br>* Super selective lateral neck lymph node dissection is performed in some of the patients in Arm B (according to sentinel lymph node biopsy results).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymph node counts | Dyed versus undyed lymph node counts in lateral neck compartments | 1 month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymph node metastasis rate | The rate of lymph node metastasis in lateral neck compartments | 1 month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thyroid cancer, lateral neck lymph node, lymph node mapping, neck dissection, sentinel lymph node