A Phase 3 interventional study of Lymph node tracer navigated selective neck dissection and Modified neck dissection in Thyroid Cancer, sponsored by Fudan University. Recruiting at 1 site in China. Open to participants aged 14 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Fudan University · Phase 3, Interventional, and Treatment
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.
802 studies on the registry are indexed under Thyroid Neoplasms; 216 are open to participants now.
This study's planned enrollment of 250 is above the median of 51 across 507 interventional studies indexed under Thyroid Neoplasms.
Browse Thyroid Neoplasms studies →Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
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Exclusion Criteria:
Procedure: Lymph node tracer navigated selective neck dissection
Procedure: Modified 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).
Lymph nodes in compartment IIA, IIB, III, IV, VB are dissected.
Local-regional Recurrence Free Survival,LRFS
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.
Time frame: 5 years
Local-regional Recurrence Rate,LRR
The percentage of patients with local-regional recurrence in the total number of patients.
Time frame: 5 years
Progression Free Survival,PFS
The time from surgery to tumor progression, including local-regional recurrence and distant metastasis.
Time frame: 5 years
Overall Survival,OS
The time from surgery to patient death
Time frame: 5 years
Adverse Events,AE
The name of AE (based on NCI-CTCAE V5.0 criteria), severity, duration, and correlation with surgery.
Time frame: 5 years
Quality of Life as assessed by UW-QOL V4.1
Quality of life assessments will be conducted at 1 week, 3 months, 1 year, 2 years, and 5 years after surgery. The QoL evaluation scale adopts the Washington University Quality of Life Questionnaire V4.1 (UW-QOL V4.1).
Time frame: 5 years
Quality of Life as assessed by QoL/Thyroid
Quality of life assessments will be conducted at 1 week, 3 months, 1 year, 2 years, and 5 years after surgery. The QoL evaluation scale adopts the Thyroid Cancer Quality of Life Scale QoL/Thyroid.
Time frame: 5 years
Plan to share: Undecided
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