Frozen Section-Guided Selective Ipsilateral Central Neck Dissection in Bethesda V-VI Thyroid Nodules (NCT07659717) | Clinical Trial Compass
CompletedNot Applicable
Frozen Section-Guided Selective Ipsilateral Central Neck Dissection in Bethesda V-VI Thyroid Nodules
Italy66 participantsStarted 2023-01-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment adequacy
Timeframe: From surgery to availability of final histopathological report, approximately 2-4 weeks after surgery.