Selective Neck Dissection Versus Modified Neck Dissection in PTC

Sponsor
Fudan University
Study ID
NCT06554652
Phase
PHASE3
Status
Recruiting
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Conditions

  • Thyroid Cancer

Eligibility Criteria

Sex
ALL
Age
14 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Lymph node tracer navigated selective neck dissection — PROCEDURE
    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).
  • Modified neck dissection — PROCEDURE
    Lymph nodes in compartment IIA, IIB, III, IV, VB are dissected.

Study Details

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.

Key Dates

First listed
Aug 15, 2024
Start date
Nov 19, 2024
Status verified
Feb 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Selective neck dissection
  • Active Comparator: Modified neck dissection

Primary Outcome Measure

Local-regional Recurrence Free Survival，LRFS [ Time Frame: 5 years ]

Central Contacts

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