Selective Neck Dissection Versus Modified Neck Dissection in PTC

Fudan University

Status and phase

Not yet enrolling

Phase 3

Conditions

Thyroid Cancer

Treatments

Procedure: Lymph node tracer navigated selective neck dissection

Procedure: Modified neck dissection

Study type

Interventional

Funder types

Other

Identifiers

NCT06554652

SELECTION

Details and patient eligibility

About

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.

Enrollment

250 estimated patients

Sex

All

Ages

14 to 80 years old

Volunteers

No Healthy Volunteers

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.