Diagnostic Accuracy of Fine Needle Aspiration in Patients With Salivary Gland Tumors.

NCT06034782 | Completed

• 1 other identifier: 18/22-02-2021
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Tumors of the salivary glands occupy 0.5-1.2% of cases of head and neck tumors. They are primarily a surgical disease, as their treatment is basically the surgical excision. In this direction and in the context of the differential preoperative diagnosis, in addition to the imaging methods, the fine needle biopsy (FNA) was used, with which cell material is aspirated from the tumor and studied under the microscope. Although an increasing number of papers have been published in the international scientific literature over the last 5 years on the diagnostic accuracy of FNA in salivary glands, many of them are unable to quantify and omit to refer information that could affect the estimated diagnostic accuracy. Such information is for instance the clinical experience of the doctor who performs the FNA and of the one who assess the smear. The aim of this retrospective study is to evaluate the diagnostic accuracy of fine needle biopsy in adult patients with salivary gland tumor that underwent a surgical excision in two Oral and Maxillofacial Departments in Northern Greece. The present retrospective study was carried out from 2/2021 to 4/2022 by collecting data from the files of patients who underwent surgery at the Oral and Maxillofacial Clinic of the Theageneio Cancer Hospital of Thessaloniki 1996-2022 and the General Hospital of Thessaloniki G. Papanikolaou 2015-2022. The study was conducted according to the STARD 2015 protocol. FNA contributed significantly to the differential preoperative process in salivary gland diseases. The differential diagnosis of a lesion in benign / malignant preoperatively, with the use of FNA, enables the surgeon for a more beneficial to the patient and oncologically safer planning of the surgery. It is considered important the high sensitivity provided by the examination, as it helps to exclude with sufficient safety the possible malignancy of the tumor located in the salivary gland of the patient.

Conditions

Salivary Gland Tumor; Diagnosis

Keywords

salivary tumors; diagnostic accuracy; Fine Needle Aspiration

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of Fine Needle Aspiration in salivary tumors

  The result FNA of salivary tumor was compared to (verified) Histologic result after tumor resection. Then Diagnostic accuracy of FNA was estimated.

  Every patient underwent FNA in a time frame from 1 day to 1 month before the surgical resection of the tumor. Then, under general anesthesia the tumor was surgicaly resected and was immediately examined to the Histology Laboratory of the Hospital.

Study Arms (1)

patients with salivary gland tumors

patients with salivary gland tumors

Diagnostic Test: Fine Needle Aspiration; Procedure: Histologic Examination

Interventions

Fine Needle Aspiration DIAGNOSTIC_TEST

Fine Needle Aspiration of a salivary gland tumor

Also known as: FNA

patients with salivary gland tumors

Histologic Examination PROCEDURE

Histologic examination of resected salivary tumor

patients with salivary gland tumors

Eligibility Criteria

• Age: 24 Years - 96 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with salivary tumors that examined in outpatient Oral and Maxillofacial Surgery Clinic of Anti-Cancer Hospital of Thessaloniki "Theageneio" and General Hospital of Thessaloniki "G. Papanikolaou".

You may qualify if:

• Adult patients \>=18 years
• salivary tumor suspected
• FNA result available
• Salivary tumor surgically resected
• Histologic result available

You may not qualify if:

• Patients under 18 years old
• FNA result or Histologic result not available
• No tumor resection
• Other neck tumors (not salivary tumor)

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Aristotle University

Thessaloniki, 54124, Greece

Location

MeSH Terms

Conditions

Salivary Gland Neoplasms; Disease

Interventions

Biopsy, Fine-Needle; Histological Techniques

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Officials

• Theodoros V. Grivas, Medical

  Aristotle University Thessaloniki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: September 13, 2023
• Study Start: February 22, 2021
• Primary Completion: May 15, 2022
• Study Completion: June 6, 2022
• Last Updated: September 13, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Immediatelly available and for 6 months
• Access Criteria: The excel database with the menioned individual participant data (IPD) can be available only for academical reason after email verification

Locations

GR (1)