JMIR Publications

ABSTRACT

Background:

Serous effusions are result of accumulation of imbalance between fluid production and absorption in all the serous cavities like pleural, peritoneal and pericardial cavities. These serous effusions could be due to various etiological factors both physiological and pathological and cytological evaluation of such effusion plays crucial role in its diagnosis and treatment. Serous fluid cytology despite being a reliable method to diagnose malignant effusions, diagnostic challenges remain in cases with equivocal cytological findings. Acknowledging these limitations, the International Academy of Cytology (IAC) in association with American Society of Cytopathology (ASC), proposed the International System for Reporting Serous Fluid Cytopathology (TIS) in 2020. The system was designed to standardize reporting terminology, improve reporting consistency and facilitate effective communication with clinicians.

Objective:

This study aims to retrospectively categorize serous fluid cytology specimens according to the International System for Reporting Serous Fluid Cytopathology (TIS), assess the distribution of cases across each diagnostic categories and determine risk of malignancy (ROM) across each TIS diagnostic category by correlation of cytological and histopathological diagnosis and clinical follow-up if available.

Methods:

This is a retrospective observational study. The study will include all the serous fluid cytology samples received during the study period from January 2024 to January2026. All serous fluid cytology samples received will be included and clinical history, laboratory and radiological investigation will be retrieved from hospital records. Duplicate specimens from the same patient (unless clinically indicated) and cases with incomplete demographic records will be excluded. The archived cytology smears will be reviewed and it will be reclassified according to the International System for Reporting Serous Fluid Cytopathology (TIS) into five diagnostic categories: Nondiagnostic (ND), Negative for Malignancy (NFM), Atypia of Undetermined Significance (AUS), Suspicious for Malignancy (SFM), and Malignant (MAL). Data will be entered into Microsoft Excel and analyzed using IBM SPSS Statistics version XX.

Results:

The Study has been approved by Institutional Ethics Committee and clearance was obtained prior to commencement of the study. This is non funded academic study. The total sample received for serous fluid cytology during the study period of January 2024 to January 2026 were 1525. Out of which 25 samples were excluded due to incomplete demographic records. Hence, sample size of 1500 samples were finalized. Data collection and retrospective review of eligible serous fluid will commence after ethical clearance and is expected to be completed by December,2026.

Conclusions:

The anticipated findings of this study are expected to provide evidence on the utility of the International Reporting for Serous Fluid Cytopathology (TIS) in standardizing serous effusion reporting, stratifying the risk of malignancy, and supporting the clinical management.