Selective Neck Dissection Versus Modified Neck Dissection in PTC

Phase

Condition

Thyroid Cancer

Treatment

Lymph node tracer navigated selective neck dissection

Modified neck dissection

Clinical Study ID

NCT06554652

SELECTION

Ages 14-80
All Genders

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 Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design