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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

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

Recruiting

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

No

none