Abstract:Objective To evaluate the imaging effects and clinical feasibility of a domestically-produced probe-based confocal laser endomicroscopy (pCLE) for differentiating benign and malignant biliary stricture. Methods Thirty-one patients with biliary stricture were enrolled at Zhongnan Hospital of Wuhan University from January 2023 to December 2024. The domestically developed pCLE system was used for imaging diagnosis for biliary stricture, based on the Miami and Paris classifications. Cytological or histopathological findings served as the gold standard, pCLE characteristics of benign and malignant biliary stricture were recorded. Results Under pCLE, normal bile ducts exhibited fine and uniform reticular dark bands against a light gray background, with mildly dilated vessels and slight fluorescein leakage, presenting a regular morphology. In 18 cases of inflammatory stricture, pCLE revealed thickened reticular dark bands, dilated and congested vessels, and significant fluorescein leakage. In 13 cases of malignant stricture, pCLE demonstrated markedly widened dark bands or coarse bright bands, tortuous and irregular vessels, island-like clusters of dark cellular masses, and epithelial architectural distortion. Conclusion The domestic pCLE system effectively identifies malignant features—including widened dark/bright bands, dark cellular clusters, twisted and irregular vessels, and epithelial necrosis—facilitating differential diagnosis of biliary strictures.