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DOI 10.37219/2528-8253-2025-6-2

Maleev DO, Zabolotnyi DI
DIAGNOSTIC ACCURACY OF SALIVARY PEPSIN EVALUATION FOR THE DIAGNOSIS OF LARYNGOPHARYNGEAL REFLUX IN PATIENTS WITH LARYNGOPHARYNGEAL CANCER
Malieiev Dmytro O
State Institution “O.S. Kolomiychenko Institute of Otolaryngology of National Academy of Med-ical Science of Ukraine”; Kyiv, Ukraine
PhD student
Email: dmytromaleev@gmail.com
ORCID ID: https://orcid.org/0009-0008-0499-7211
Zabolotnyi Dmitry I
State Institution “O.S. Kolomiychenko Institute of Otolaryngology of National Academy of Medical Science of Ukraine”; Kyiv, Ukraine. Director
Doctor of Medical Sciences, Professor, Academician of the National Academy of Medical Sciences of Ukraine
E-mail: amtc@kndio.kiev.ua
https://www.scopus.com/authid/detail.uri?authorId=6701512931
ORCID ID: https://orcid.org/0000-0001-9429-4414
Abstract

Background: Laryngopharyngeal reflux (LPR) is a common comorbidity in patients with malignant neoplasms of the laryngopharynx and is considered a co-factor in carcinogenesis. Diagnosing LPR in this population is challenging because methods with the highest sensitivity, such as 24-hour pH monitoring, are invasive, poorly tolerated by patients, and often contraindicated. Meanwhile, user-friendly visual analog scales (VAS) lack sufficient diagnostic sensitivity and specificity, necessitating the search for new methods of LPR diagnosis.

Objective: To evaluate and compare the diagnostic accuracy of salivary pepsin determination and clinical scales (Reflux Symptom Index [RSI]; Reflux Finding Score [RFS]) for diagnosing LPR in patients with malignant neoplasms of the laryngopharynx.

Materials and Methods: A prospective diagnostic accuracy study included 50 patients with histologically verified stage III-IV laryngopharyngeal cancer. All patients underwent assessment using RSI/RFS scales (index tests), salivary pepsin analysis (index test), and 24-hour pH monitoring (reference standard).

Results: LPR was confirmed in 31 (62%) patients. Salivary pepsin evaluation had a sensitivity of 74.2% (95% CI: 55.4%88.1%) and specificity of 78.9% (95% CI: 54.4%–94.0%). These values exceeded the accuracy of the combined RSI/RFS scales (sensitivity 67.7% [95% CI: 48.6%–83.3%]; specificity 68.4% [95% CI: 43.4%–87.4%]).

Conclusions: Salivary pepsin evaluation is a promising, non-invasive diagnostic method for detecting LPR in patients with laryngopharyngeal cancer, demonstrating higher diagnostic accuracy compared to clinical scales. This method requires further validation in larger studies.

Keywords: 24-hour pH monitoring; laryngopharyngeal reflux; pepsin; saliva; laryngopharyngeal cancer.

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