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

NCT07659717 | Completed

• 1 other identifier: PA-1-RETRO-2026-TBD
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Frozen section analysis; Papillary Thyroid Cancer; Central Neck Dissection; Clinically Node-Negative Thyroid Cancer; Intraoperative Decision-Making; Treatment Adequacy

Outcome Measures

Primary Outcomes (1)

• Treatment adequacy

  concordance between the surgical procedure performed and the minimum surgical treatment considered necessary for appropriate locoregional disease control, as determined retrospectively on the basis of final histopathological findings. Surgical treatment will be classified as adequate, overtreatment, or undertreatment. Overtreatment is defined as total thyroidectomy in patients ultimately found to have a solitary unilateral carcinoma without adverse pathological features. Undertreatment is defined as an insufficient surgical extent in the presence of adverse pathological features requiring a more comprehensive oncological procedure.

  From surgery to availability of final histopathological report, approximately 2-4 weeks after surgery.

Secondary Outcomes (2)

• Complications

  From surgery to postoperative follow-up, approximately 30-60 days after surgery.

• Length of hospital stay

  From surgery to hospital discharge, usually within 1-3 days after surgery.

Study Arms (2)

FSA Group

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.

Procedure: Frozen section analysis (FSA)

non-FSA Group

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.

Interventions

Frozen section analysis (FSA) PROCEDURE

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.

FSA Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes consecutive adult patients treated in a tertiary referral endocrine surgery unit who underwent primary thyroid surgery for cytologically suspicious or malignant thyroid nodules. Eligible patients had Bethesda V or VI thyroid cytology, a solitary low-risk thyroid nodule smaller than 2.5 cm, and a clinically node-negative neck documented by preoperative cervical ultrasound. All patients were managed according to institutional surgical protocols and had prospectively collected clinical, surgical, and histopathological data available for analysis.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eleonora Lori, MD: lead
• University of Palermo: collaborator

Study Sites (1)

Policlinico "P. Giaccone" University of Palermo

Palermo, Sicily, 90127, Italy

Location

MeSH Terms

Conditions

Thyroid Cancer, Papillary; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gregorio Scerrino, MD

  Policlinico "P. Giaccone" University of Palermo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 22, 2026
• Study Start: January 9, 2023
• Primary Completion: June 27, 2025
• Study Completion: September 19, 2025
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)