Diagnostic Utility of Digital Single-Operator Cholangioscopy for Risk-Enriched Detection and Surveillance of Intraductal Neoplasms of the Bile Duct: SPY-SCREEN Study (with Videos).

BACKGROUND AND AIM: Detection of intraductal neoplasms of the bile duct (IN-Bs) remains suboptimal despite various diagnostic modalities. We evaluated the efficacy of digital single-operator cholangioscopy (D-SOC) for screening and surveillance of IN-Bs in patients with bile duct dilatation after stone removal.

METHODS

In a prospective cohort of 181 patients with post-stone removal common bile duct dilatation (> 10 mm), screening D-SOC was followed by two rounds of surveillance at 1-year intervals. Outcomes included cumulative incidence of IN-Bs, technical success of D-SOC and D-SOC-guided biopsy, and number needed to screen (NNS) to identify a neoplastic lesion at each round.

RESULTS

Technical success of D-SOC was achieved in all patients. Among 181 patients who underwent D-SOC, nine were diagnosed with IN-Bs: cholangiocarcinoma (CCA) (n = 3), intraductal papillary neoplasms of the bile duct (n = 5), and adenoma with dysplasia (n = 1). Curative resection was performed in two patients with CCA. The cumulative incidence of IN-Bs was 6.3% (95% confidence interval, 2.4-10.7%). The NNS values to detect one neoplastic lesion were 29.4, 21.8, and 9.7 at initial screening and 1- and 2-year surveillance.

CONCLUSION

D-SOC can be useful for risk-enriched detection and surveillance of IN-Bs in patients with post-stone-removal biliary dilatation, warranting further evaluation in those with additional CCA risk factors (clinical trial registration number: NCT05600803).