RecruitingPhase 3NCT06554652

Selective Neck Dissection Versus Modified Neck Dissection in PTC

Tracer Navigated Selective Neck Dissection Versus Modified Neck Dissection in Papillary Thyroid Cancer With Limited Lymph Node Metastasis in the Lateral Neck: A Randomized, Noninferiority Phase III Trial

Sponsor

Fudan University

Enrollment

250 participants

Start Date

Nov 19, 2024

Study Type

INTERVENTIONAL

Conditions

Thyroid Cancer

Summary

This study is a phase III, randomized controlled, open label non inferiority study. Patients who meet the inclusion criteria are randomly assigned 1:1 to either the experimental group (selective neck dissection) or the control group (modified neck dissection), with LRFS as the primary endpoint. The aim of the study is to evaluate the safety of selective neck dissection in papillary carcinoma with limited number of lymph node metastases in the lateral neck, and the quality of life compared with modified neck dissection.

Eligibility

Min Age: 14 YearsMax Age: 80 Years

Inclusion Criteria6

Pathologically confirmed PTC;
Age range: 14-80 years old;
Preoperative fine needle aspiration confirms lymph node metastasis in the lateral neck
Ultrasound and CT suggest that metastatic/suspected metastatic lymph nodes are limited to compartment IV, with 1-2 lymph node metastases and \<1cm in short diameter. The lymph nodes have no central necrosis, liquefaction, peripheral enhancement, or disappearance of adjacent fat spaces (predicting unobstructed lymphatic vessels);
Thyroid tumors without extra thyroidal extension;
Enough thyroid volume to inject tracer.

Exclusion Criteria6

Previous neck surgery;
Bilateral neck lymph node dissection;
Distant metastases;
High risk pathological subtypes or the presence of other high-risk factors for recurrence;
Previous treatment for thyroid cancer other than endocrine therapy;
The patient is unable to cooperate with follow-up.

Interventions

PROCEDURELymph node tracer navigated selective neck dissection

Selective lateral lymph node dissection (after injection of tracer, lymph nodes in compartment III-IV are dissected; if there is dyed lymph node in compartment IIA, then IIA is dissected).

PROCEDUREModified neck dissection

Lymph nodes in compartment IIA, IIB, III, IV, VB are dissected.