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Frozen Section-Guided Selective Ipsilateral Central Neck Dissection in Bethesda V-VI Thyroid Nodules

NCT07659717 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 66

Last updated 2026-06-24

No results posted yet for this study

Summary

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

  • Papillary Thyroid Cancer
  • Lymph Node Metastasis

Interventions

PROCEDURE

Frozen section analysis (FSA)

Frozen section analysis (FSA) is an intraoperative pathological technique used to provide a rapid assessment of excised tissue during surgery. In this study, ipsilateral level VI lymph nodes were removed and immediately sent to the pathology department, where they were frozen, sectioned using standard cryostat techniques, stained with hematoxylin and eosin, and examined by an experienced pathologist. The result was reported intraoperatively as positive or negative for lymph node metastasis and used to support real-time surgical decision-making.

Sponsors & Collaborators

  • University of Palermo

    collaborator OTHER

  • Eleonora Lori, MD

    lead OTHER

Principal Investigators

  • Gregorio Scerrino, MD · Policlinico "P. Giaccone" University of Palermo

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-09
Primary Completion
2025-06-27
Completion
2025-09-19

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07659717 on ClinicalTrials.gov