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

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

Plain Language Summary

Simplified for easier understanding

This trial is comparing two different surgical approaches for removing lymph nodes in the neck in patients with papillary thyroid cancer (PTC) that has spread to nearby lymph nodes — selective neck dissection (removing only the specific lymph node area involved) versus modified radical neck dissection (a more extensive removal). The goal is to see if the less extensive approach is equally effective with fewer side effects. **You may be eligible if...** - You are 14–80 years old with confirmed papillary thyroid cancer - A biopsy has confirmed lymph node spread specifically to the lateral neck (compartment IV) - You have only 1–2 involved lymph nodes, each smaller than 1 cm short diameter - Your thyroid tumor has not spread through the thyroid capsule **You may NOT be eligible if...** - You have had previous neck surgery - You need lymph node removal on both sides of the neck - Your cancer has spread to distant organs - You have high-risk pathological features or other high-risk factors for recurrence - You cannot return for follow-up appointments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Fudan Univeristy Shanghai Cancer Center

Shanghai, China

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NCT06554652


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