Clinical trial · Interventional
Selective Neck Dissection Versus Modified Neck Dissection in PTC
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lymph node tracer navigated selective neck dissection | Procedure | — | UNRESOLVED |
| Modified neck dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Selective neck dissection
- interventionNames
- Procedure: Lymph node tracer navigated selective neck dissection
- type
- ACTIVE_COMPARATOR
- label
- Modified neck dissection
- interventionNames
- Procedure: Modified neck dissection
Primary outcomes (1)
- measure
- Local-regional Recurrence Free Survival，LRFS
- timeFrame
- 5 years
- description
- 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.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available