Lateral Neck Lymph Node Mapping in Thyroid Cancer

Not Applicable

• Conditions: Thyroid Cancer
• Interventions: Procedure: Modified lateral neck lymph node dissection; Procedure: Lateral neck sentinel lymph node biopsy; Procedure: Super selective lateral neck lymph node dissection

• Registration Number: NCT04312087
• Lead Sponsor: Fudan University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-08-01
• Status Verified: 2020-03
• Study First Submitted: 2020-03-14
• Study First Submitted QC: 2020-03-16
• Last Update Submitted: 2020-03-16
• Study First Posted: 2020-03-18
• Last Update Posted: 2020-03-18
• Primary Completion: 2021-08-01
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MLND	Modified lateral neck lymph node dissection	Modified lateral neck dissection (compartment II-V) is performed in all patients.
SLNB	Modified lateral neck lymph node dissection	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.
SLNB	Lateral neck sentinel lymph node biopsy	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.
SLNB	Super selective lateral neck lymph node dissection	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.

Primary Outcome Measures

Name	Time	Method
Lymph node counts	1 month after surgery	Dyed versus undyed lymph node counts in lateral neck compartments

Secondary Outcome Measures

Name	Time	Method
Lymph node metastasis rate	1 month after surgery	The rate of lymph node metastasis in lateral neck compartments

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China