Diagnostic performance of single-operator cholangioscopy (SOC) (overall and indeterminate biliary strictures (IDBS))*
| Performance criteria (95% CI) | Overall | IDBS |
| (a) SOC visual impression (PI) | ||
| Se | 63.6 (40.7 to 82.8) | 64.7 (38.3 to 85.8) |
| Sp | 100 (93 to 100) | 100 (88.8 to 100) |
| PPV | 100 (76.8 to 100) | 100 (71.5 to 100) |
| NPV | 86.4 (75 to 94) | 83.8 (68.0 to 93.8) |
| (b) SOC visual impression + pathology (PI) | ||
| Se | 54.5 (32.2 to 75.6) | 56.3 (29.9 to 80.2) |
| Sp | 100 (93 to 100) | 100 (89.1 to 100) |
| PPV | 100 (73.5 to 100) | 100 (66.4 to 100) |
| NPV | 83.6 (71.9 to 91.8) | 82.1 (66.5 to 92.5) |
| (c) Expert review 1 (AL) for SOC visual impression + pathology | ||
| Kappa (CI95%) PI vs AL overall: 0.94 (0.84–1.0)/IDBS: 0.92 (0.80–1.00) | ||
| Se | 57.1 (34.0 to 78.2) | 56.3 (29.9 to 80.2) |
| Sp | 100 (93 to 100) | 100 (89.1 to 100) |
| PPV | 100 (73.5 to 100) | 100 (66.4 to 100) |
| NPV | 85.0 (73.4 to 92.9) | 82.1 (66.5 to 92.5) |
| (d) Expert review 2 (SG) SOC visual impression + pathology | ||
| Kappa (CI95%) PI vs SG overall: 0.97 (0.90–1.0)/IDBS: 0.96 (0.86–100) | ||
| Se | 52.0 (29.8 to 74.3) | 50.0 (24.7 to 75.3) |
| Sp | 100 (93 to 100) | 100 (89.1 to 100) |
| PPV | 100 (71.5 to 100) | 100 (63.1 to 100) |
| NPV | 83.6 (71.9 to 91.8) | 80 (64.4 to 90.9) |
*Indeterminate visual impression is classified as negative for malignancy.
PI, classification by principal investigators (SL, FP).
NPV, negative predictive value; PPV, positive predictive value; SE, sensitivity; SP, specificity