Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06034782 |
| Other study ID # |
18/22-02-2021 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 22, 2021 |
| Est. completion date |
June 6, 2022 |
Study information
| Verified date |
August 2022 |
| Source |
Aristotle University Of Thessaloniki |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
Description:
This retrospective study was conducted according to the STARD 2015 protocol. A thorough
retrospective analysis of patient data that were extracted from patient records of a tertiary
referral hospital database was performed. The patient files which were included in the study
are electronically archived at the Departments of Oral and Maxillofacial Surgery of
"Theageneio Anti-Cancer Hospital of Thessaloniki" and of General Hospital of Thessaloniki
"George Papanikolaou".
Patients who were included in the present study, except for clinical examination by an Oral
and Maxillofacial Surgeon, also underwent at least one imaging modality (MRI, CT scan,
ultrasound scan).
This retrospective study was carried out from 2/2021 to 4/2022. Data from records of patients
who underwent salivary tumour surgery at the Oral and Maxillofacial Surgery departments of
Theageneio Anti-Cancer Hospital of Thessaloniki 1996-2022 and of the General Hospital of
Thessaloniki G. Papanikolaou 2015-2022 were collected.
The surgical treatment of all patients with salivary gland tumors who were examined by a
practitioner of the two aforementioned Maxillofacial departments, was based on their
chronological attendance at the outpatient clinic, while there was no attempt of grouping of
them.
Based on the FNA report, FNA results were categorized as follows: Benign, Malignant,
Non-diagnostic, Unavailable result. The same categories were obtained for the reference
standard test, which was the histopathological examination of the resected tumor.
The sample size was calculated using the software G power analysis version 3.1.9.6. For α =
0.05 and study strength Power 0.95 a sample size of 102 patients had been obtained which was
relatively smaller compared to the 128 patients that were finally included in the study.
During the data collection from the medical patient records, there were 11 (n = 11) out of
139 (n = 139) cases whose FNA result and 4 (n=4) out of 184 (n=184) whose histological result
was non-diagnostic as it was not clearly concluded whether the lesion was benign or
malignant. These cases were excluded from the estimation of diagnostic accuracy indicators.
Likewise to the non-diagnostic results, were excluded the 145 (n = 145) FNA results that were
not available.
To assess the diagnostic accuracy of FNA, a comparative process among FNA and
histopathological outcomes was conducted. Sensitivity, specificity, positive predictive
value, negative predictive value, positive likelihood ratio, negative likelihood ratio, ROC
curve and AUC (Area Under curve) were calculated. Calculations were made using software
RStudio Version 1.4.1106 © 2009-2021 RStudio, PBC "Tiger Daylily" (2389bc24, 2021-02-11) for
Windows Mozilla/5.0 (Windows NT 10.0; Win64; x64) Apple Web Kit/537.36 (KHTML, like Gecko) Qt
Web Engine/5.12.8 Chrome/69.0.3497.128 Safari/537.36.
