Accuracy of FNAC in Thyroid Nodules Compared to to Surgical Specimen : QOC Experience

NCT ID: NCT05521594

Last Updated: 2022-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-07-31

Brief Summary

Thyroid gland diseases are the second most common endocrine disease following diabetes mellitus(1). Thyroid nodules are common disorders with a prevalence ranged from 4 to 7% in adult population, 5%-30% are malignant [1].Fine-needle aspiration cytology (FNAC) is an easy, cost-effective test for cancer diagnosis, and its use has markedly decreased the number of unnecessary thyroid surgeries(2).

Detailed Description

it should be noted that FNAC cannot differentiate between benign and malignant follicular neoplasms.differentiation between follicular adenoma and follicular carcinoma is only possible after thyroid lobectomy.[2,3] In addition, a study of FNAC showed that 68% of the cases diagnosed by FNAC as follicular neoplasm turned out to be the follicular type of papillary carcinoma, indicting a considerable overlap between benign and malignant neoplasms.[4] Incidental findings of thyroid nodules have increased exponen¬tially in recent years, mostly due to the widespread application of high-resolution ultrasound (US) to the thyroid [5].Several in¬ternational scientific societies have established clinic-radiolog¬ical guidelines for the diagnosis and the management of thy¬roid nodules [2,3]. The American College of Radiology identifies 5 radiological risk levels and recommends US-guided fine-nee¬dle aspiration cytology (US-FNAC) of high-suspicion nodules if 10 mm or larger, and of nodules with a low risk for malignan¬cy only if larger than 25 mm [2]. According to the European Thyroid Association Guidelines (EU-TIRADS), nodules with no high-risk features (oval-shaped, isoechoic/hyperechoic with smooth margins) should be considered at low risk and FNA performed only if greater than 20 mm, while high-risk nodules greater than 10 mm should undergo FNAC, with possible FNAC also in 5-10 mm nodules if highly suspicious [3].

Conditions

Fine Needle Aspiration Cytology; Thyroid Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FNAC

Group Type: EXPERIMENTAL

Fine Needle Aspiration Cytology

Intervention Type: PROCEDURE

Comparison between FNAC and post operative specimen after thyroid surgery

post operative hitopathology

Group Type: EXPERIMENTAL

Fine Needle Aspiration Cytology

Intervention Type: PROCEDURE

Comparison between FNAC and post operative specimen after thyroid surgery

Interventions

Fine Needle Aspiration Cytology

Comparison between FNAC and post operative specimen after thyroid surgery

Intervention Type: PROCEDURE

Other Intervention Names

Thyrodectomy

Eligibility Criteria

Inclusion Criteria

• Thyroid diseases
• Multi nodullar
• single nodules
• diffuse goiter
• Thyroid diseases underwent FNAC Then Thyroid surgery

Exclusion Criteria

• Patients with no diagnostic FNAC

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qena Oncology Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Mohamed Ahmed Orabi

specialist of surgical oncology at Qena Oncology Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amr M Makky, specialist surgical onclogy

Role: STUDY_DIRECTOR

Qena Oncology Center- Medical Military Academy

Abdullah Atyah Ali, Ass.Lecture General Surgery

Role: STUDY_DIRECTOR

Qena Oncology Center--Luxor University

Mohamed Ahmed Orabi, specialist surgical onclogy

Role: PRINCIPAL_INVESTIGATOR

Qena Oncology Center

Mina Romany Tawfeek

Role: STUDY_CHAIR

Qena Oncology Center

Mahmoud Ahmed Dosoky, specialist pathology

Role: STUDY_DIRECTOR

Qena Oncology Center

Locations

Qena Oncology Center

Qina, , Egypt

Countries

Egypt

Other Identifiers

Qena Oncology Center 2

Identifier Type: -

Identifier Source: org_study_id