Lateral Neck Lymph Node Mapping in Thyroid Cancer

Fudan University

Status: Unknown

Conditions: Thyroid Cancer

Treatments: Procedure: Super selective lateral neck lymph node dissection; Procedure: Modified lateral neck lymph node dissection; Procedure: Lateral neck sentinel lymph node biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04312087

TC-MAP

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 14 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

MLND

Experimental group

Description:

Modified lateral neck dissection (compartment II-V) is performed in all patients.

Treatment:

Procedure: Modified lateral neck lymph node dissection

SLNB

Experimental group

Description:

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.

Treatment:

Procedure: Super selective lateral neck lymph node dissection

Procedure: Lateral neck sentinel lymph node biopsy

Procedure: Modified lateral neck lymph node dissection