NCT07659717Completed
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 · Last updated 24 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 66 (actual)
- First submitted
- 15 Jun 2026
- Start date
- Jan 2023
- Primary completion date
- Jun 2025
- Lead sponsor
- Eleonora Lori, MD
- Diseases
- Thyroid cancer
- NCT number
- NCT07659717
What you commit to
- Study type: Observational
- Participants enrolled: 66
- From Jan 2023 to the primary completion date, Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Age
- Age younger than 18 years.
Other
- Thyroid nodule measuring 2.5 cm or more in maximum diameter.
- Incomplete clinical and pathological data relevant to the study endpoints.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Policlinico "P. Giaccone" University of Palermo Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.