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Role of Frozen Section in Categorization of Thyroid Follicular Neoplasm

Role of Frozen Section in Categorization of Thyroid Follicular Neoplasm

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06947629
Enrollment
48
Registered
2025-04-27
Start date
2025-05-02
Completion date
2027-05-02
Last updated
2025-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Role of Frozen Section in Categorization of Thyroid Follicular Neoplasm

Brief summary

The goal of this prospective study is to assess the effectiveness of frozen section in distinguishing between benign and malignant tumors in the category of follicular thyroid neoplasm to prevent over-surgery for benign follicular neoplasm (lobectomy Vs total thyroidectomy). The main questions, it aims to answer are: The follicular neoplasm is benign or malignent? how far is FNAC valid and accurate? Researchers will compare the results of frozen section and paraffin embedded sections to evaluate the validity and accuracy of FNAC.

Detailed description

Thyroid tumors are the most common endocrine neoplasms, with their incidence steadily rising over the past few decades, reaching approximately 8.7 cases per 100,000 people annually in Europe. The majority of thyroid tumors are benign accounting for over 90% of cases, whereas malignant thyroid tumors are relatively less common. Thyroid cancer represents 1-2% of all newly diagnosed malignancies worldwide, with papillary thyroid carcinoma (PTC) being the most prevalent (80%) followed by follicular thyroid carcinomas (FTC) (15%). Fine needle aspiration cytology (FNAC) is the primarily diagnostic tool for thyroid nodule. However, its accuracy in distinguishing between benign and malignant follicular neoplasms is limited, necessitating further histopathological evaluation. The Bethesda system classifies FNAC results into six categories, with follicular neoplasm/suspicious for follicular neoplasm (category IV) carrying a moderate risk of malignancy. Differentiating between benign and malignant follicular neoplasms requires assessing capsular and vascular invasion. Intraoperative frozen section (FS) has been used for decades to provide rapid histologic assessment guiding the extent of surgery (lobectomy Vs total thyroidectomy). However, its utility remains controversial due to variability in diagnostic accuracy and cost-effectiveness. The recent 5th edition of the WHO classification (2023) categorizes follicular-derived thyroid tumors into benign, low-risk and malignant neoplasms, further refining diagnostic criteria. This study aims to evaluate the accuracy of FNAC and FS in diagnosing follicular thyroid neoplasms, optimizing surgical decisions and reducing unnecessary total thyroidectomies in benign cases.

Interventions

DIAGNOSTIC_TESTIntraoperative Frozen Section

Intraoperative Frozen Section analysis which will include the following steps: \- The specimen will undergo both gross and microscopic examination: 1. Gross examination: Evaluation of nodular features including, multiplicity, size, outlines, color and consistency. 2. Microscopic examination: Assessment of capsular pattern, capsular invasion, thickness of capsule, vascular invasion and number of invaded vessels and the presence or absence of papillary structures.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Cases presented with a thyroid nodule, diagnosed as follicular neoplasm (Bethesda category IV) by fine needle aspiration cytology, and underwent hemi-thyroidectomy.

Exclusion criteria

* Cases with thyroid nodule and diagnosed by fine needle aspiration cytology as non-neoplastic lesions, suspicious for malignancy or as malignant.

Design outcomes

Primary

MeasureTime frameDescription
Role of frozen section evaluation in the diagnosis of malignant follicular neoplasm from benign in Thyroid Follicular Neoplasmtwo weeksRole of frozen section evaluation in the diagnosis of malignant follicular neoplasm from benign.

Secondary

MeasureTime frame
Assessment of the accuracy of fine needle aspiration cytology in diagnosis of follicular neoplasm.three weeks

Countries

Egypt

Contacts

Primary ContactMohamed H Sayed, MBBCh
MohamedHamdy2020@med.nvu.edu.eg+201004419027
Backup ContactMahmoud F Sherif, Assistant professor
M.farouk.pathology@aun.edu.eg01002763939

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026