Status:
NOT_YET_RECRUITING
Selective Neck Dissection Versus Modified Neck Dissection in PTC
Lead Sponsor:
Fudan University
Conditions:
Thyroid Cancer
Eligibility:
All Genders
14-80 years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2029
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06554652
Start Date
September 1 2025
End Date
June 30 2029
Last Update
September 3 2025
Active Locations (1)
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1
Fudan Univeristy Shanghai Cancer Center
Shanghai, China