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Evaluation of the Diagnostic Accuracy for Early Malignant Transformation of Oral Mucosal Diseases Using IPCL Classification via Narrow Band Imaging and Brush Cytology and Needle Cytology

Evaluation of the Diagnostic Accuracy for Early Malignant Transformation of Oral Mucosal Diseases Using IPCL Classification via Narrow Band Imaging and Brush Cytology and Needle Cytology

100

Patients with suspected potentially malignant oral lesions or oral cancer

This prospective cohort study was conducted at the Department of Oral Surgery, Iwate Medical University, and included patients with OPMDs or OSCC between 1 December 2023 and 1 March 2026. All procedures conformed to the Declaration of Helsinki (Japanese Medical Association translation; revised at the WMA General Assembly in Helsinki, Finland). The study adhered to the STROBE and STARD guidelines. Written informed consent was obtained from all participants. Ethical approval was granted by the Ethics Review Committee of Iwate Medical University (Reference Number: MH2023-075).

In this study, no adverse events were observed during the observation period.

The patient cohort comprised 45 men and 55 women (mean age 67.2 years, range 27-99 years). The sites examined were the tongue in 39 cases, the gingiva in 30 cases, the buccal mucosa in 24 cases, the hard palate in 5 cases, the lip in 1 case and the floor of the mouth in 1 case. The results of the pathological assessment, which served as the basis for evaluation, were as follows: 21 cases of OLP, 52 cases of clinical oral leukoplakia (of which 27 were ONILM, 16 were OLSIL and 9 were OHSIL), and 27 cases of OSCC. The diagnostic accuracy of IPCL was 88.9 per cent in terms of sensitivity, whilst that of brush cytology was 55.6 per cent and that of needle cytology was 52.8 per cent. The diagnostic accuracy of the combined use of IPCL and brush cytology was 94.4 per cent in terms of sensitivity, whilst that of the combined use of IPCL and needle cytology was 97.2 per cent.n the comparison of diagnostic accuracy, no statistically significant differences were observed between brush cytology and needle cytology, or between brush cytology plus IPCL and brush cytology plus IPCL. However, statistically significant differences in diagnostic accuracy were observed when IPCL was added to the following combinations: brush cytology versus brush cytology plus IPCL, and needle cytology versus needle cytology plus IPCL.

It has been suggested that combining cytological findings with IPCL findings enables the assessment of cytological atypia and superficial angiogenesis; by inferring malignant transformation from these results, this approach can serve as a basis for clinical decision-making, such as determining whether a biopsy is necessary, selecting the biopsy site, and deciding on follow-up intervals.

June. 25, 2026

https://doi.org/10.1016/j.jormas.2026.102884

No

https://jrct.mhlw.go.jp/latest-detail/jRCT1022250054

akimoto yuuki

Oral Surgery, Division of Oral and Maxillofacial Reconstructive Surgery, Iwate Medical University School of Dentistry

1-1-1, Iida-dori, Yahaba-cho, Shiwa-gun, Iwate Prefecture

akimoto@iwate-med.ac.jp

akimoto yuuki

Oral Surgery, Division of Oral and Maxillofacial Reconstructive Surgery, Iwate Medical University School of Dentistry

1-1-1, Iida-dori, Yahaba-cho, Shiwa-gun, Iwate Prefecture

+81-19-651-5111

akimoto@iwate-med.ac.jp

Complete

Mar. 04, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

diagnostic purpose

Patients undergoing follow-up for oral cancer who are attending the Oral Surgery Department of the Dental Care Centre at the Uchimaru Medical Centre from 1 December 2023 to 31 March 2026, or the Oral Surgery Department of Iwate Medical University Hospital from 1 April 2026 to 1 December 2026, and who have oral mucosal lesions suspected of malignancy, orally latent malignant lesions, and oral cancer, and who consent to participation in this study.

(1) When the patient has severe physical symptoms making cooperation with the study difficult
(2) When the patient has severe mental symptoms (severe cognitive impairment, severe depressive state) making cooperation with the study difficult
(3) When the patient has difficulty understanding Japanese
(4) Other cases where the investigator deems participation in the study inappropriate
(5) When the patient is a minor

Both

Oral lichen planus Oral leukoplakia Oral squamous cell carcinoma

(1) NBI magnifying endoscopy
Following acquisition of informed consent from patients enrolled in this study, the oral mucosa is examined using NBI magnifying endoscopy and the findings recorded.
(2) Cytological and Histopathological Examination
Following the aforementioned NBI-enhanced magnifying endoscopy, we performed scraping cytology, fine-needle aspiration cytology, and histopathological examination (biopsy). We then compared cytological and histopathological diagnostic images with the microvascular patterns, changes in surface microarchitecture, and boundary regions between altered and normal mucosa observed via NBI-enhanced endoscopy. We also examined site specificity.

oral squamous cell carcinoma; oral potentially malignant disorders; early diagnosis

intra-epithelial papillary loop; cytology;

D017676D007972D000077195

D042241

1. IPCL Classification 2. Fine-Needle Aspiration Cytology Assessment 3. Smear Cytology Assessment

1. Site-specificity 2. Comparison of homogeneous and heterogeneous lesions

+81-19-651-5111

Nov. 16, 2023

none