Lymph 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).
Modified neck dissection: Lymph nodes in compartment IIA, IIB, III, IV, VB are dissected.
Study 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
Sex
ALL
Min age
14 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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.
Primary outcome measure(s)
Local-regional Recurrence Free Survival，LRFS — 5 years The time from surgery to the recurrence based on RECIST 1.1,. The definition of local-regional areas includes thyroid area, cervical I-VII lymph nodes, and retropharyngeal lymph nodes.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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