Indeterminate biliary strictures remain a major diagnostic challenge due to the high prevalence of underlying malignancy. Single-operator peroral cholangioscopy enables direct intraductal visualization and targeted biopsies. This study aimed to assess the diagnostic performance of visual assessment alone in differentiating malignant from benign biliary strictures.

We conducted a retrospective single-center study including 26 patients (February 2023–May 2025) with indeterminate biliary strictures despite inconclusive imaging and cytology. Cholangioscopic appearances were categorized as suggestive of malignancy (irregular mucosa, neo-vessels, nodules) or non-suggestive (regular mucosa, inflammatory/postoperative changes). The final diagnosis was established by histopathology or ≥6-month clinical follow-up. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated with 95% confidence intervals (CI).

Cholangioscopy was technically successful in all patients (26/26). Visual assessment suggested malignancy in 14 cases, of which 10 were confirmed malignant and 16 benign. Visual evaluation demonstrated excellent diagnostic performance : 

• Sensitivity of 100% (95% CI 69.2–100)
• Specificity of 87.5% (95% CI 61.7–98.4)
• PPV of 83.3% (95% CI 51.6–97.9)
• NPV of 100% (95% CI 76.8–100)
• Accuracy of 92.3%.

No major adverse events were observed.

In this North African series, visual assessment by cholangioscopy showed excellent sensitivity and negative predictive value for indeterminate biliary strictures. Direct visualization can reliably guide early clinical decisions and biopsy targeting, reducing the need for additional invasive testing, while maintaining a favorable safety profile.