Selective Neck Dissection Versus Modified Neck Dissection in PTC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lymph node tracer navigated selective neck dissection, Modified neck dissection.
- Who it may be relevant to
- Registry conditions: Thyroid Cancer. Basic parameters: 14 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Procedure 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). - Procedure Modified neck dissection
Lymph nodes in compartment IIA, IIB, III, IV, VB are dissected.
Primary outcome measures
- Local-regional Recurrence Free Survival，LRFS [Time frame: 5 years]
Secondary outcome measures (6)
- Local-regional Recurrence Rate，LRR [Time frame: 5 years]
- Progression Free Survival，PFS [Time frame: 5 years]
- Overall Survival，OS [Time frame: 5 years]
- Adverse Events，AE [Time frame: 5 years]
- Quality of Life as assessed by UW-QOL V4.1 [Time frame: 5 years]
- Quality of Life as assessed by QoL/Thyroid [Time frame: 5 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan Univeristy Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT06554652 · SELECTION