Clinical trial · Observational
Frozen Section-Guided Selective Ipsilateral Central Neck Dissection in Bethesda V-VI Thyroid Nodules
Frozen Section-Guided Selective Ipsilateral Central Neck Dissection in Bethesda V-VI Thyroid Nodules: A Pilot Cohort Study Informing Surgical Extent
- 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)
The goal of this observational pilot cohort study is to evaluate the feasibility and clinical implications of frozen section analysis-guided selective ipsilateral central neck dissection in adult patients undergoing primary thyroid surgery for Bethesda V-VI thyroid nodules with a clinically node-negative neck. The main questions it aims to answer are: * Can intraoperative frozen section analysis of ipsilateral level VI lymph nodes meaningfully inform real-time surgical decision-making? * Can this strategy support tailored escalation or de-escalation of central compartment surgery while minimizing unnecessary bilateral central neck dissection and its associated morbidity? Researchers will compare patients managed with ipsilateral central neck dissection and intraoperative frozen section analysis with patients managed without frozen section analysis, in order to evaluate differences in treatment adequacy, surgical decision-making, and pathological nodal assessment. Participants will undergo primary thyroid surgery according to institutional practice. In patients managed with the frozen section analysis-guided strategy, one or more ipsilateral level VI lymph nodes will be removed during surgery and examined intraoperatively. The result of frozen section analysis may be used to guide the extent of central compartment surgery and the overall surgical strategy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymph Node Metastasis | — | UNRESOLVED | — |
| Papillary Thyroid Cancer | Thyroid Gland Papillary Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Frozen section analysis (FSA) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- FSA Group
- description
- Participants in the FSA group underwent hemithyroidectomy with selective ipsilateral central neck dissection. One or more ipsilateral level VI lymph nodes were removed during surgery and submitted for intraoperative frozen section analysis (FSA). The frozen section result was used to inform real-time surgical decision-making and to guide possible escalation or de-escalation of the surgical strategy.
- interventionNames
- Procedure: Frozen section analysis (FSA)
- label
- non-FSA Group
- description
- Participants in the non-FSA group underwent total thyroidectomy according to the 2015 American Thyroid Association guidelines and the institutional standard practice. The surgical strategy was based on preoperative cytology, cervical ultrasound findings, clinical risk assessment, and multidisciplinary evaluation. Central compartment lymph node management was performed according to the surgeon's judgment and preoperative findings.
Primary outcomes (1)
- measure
- Treatment adequacy
- timeFrame
- From surgery to availability of final histopathological report, approximately 2-4 weeks after surgery.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age 18 years or older. * Adult patients undergoing primary thyroid surgery. * Preoperative thyroid cytology classified as Bethesda V or Bethesda VI according to the Bethesda System for Reporting Thyroid Cytopathology. * Presence of a solitary thyroid nodule. * Maximum nodule diameter less than 2.5 cm. * Low-risk thyroid nodule according to clinical, cytological, and ultrasound criteria. * Clinically node-negative neck, documented by preoperative cervical ultrasound. * Availability of complete histopathological report for the thyroid specimen. * Availability of complete histopathological report for central compartment lymph nodes, when removed. * Written informed consent for surgery and for the use of clinical and pathological data for research purposes. Exclusion Criteria: * Age younger than 18 years. * Previous thyroid or neck surgery, including completion thyroidectomy or secondary lymph node dissection * Known cervical lymph node metastases or distant metastases at the time of surgery. * Thyroid nodule measuring 2.5 cm or more in maximum diameter. * Incomplete clinical and pathological data relevant to the study endpoints.
References
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