Table 3.
20G ProCore™ performance on pancreatic lesions
| 20G PC performance | Pancreatic lesions (n=236) |
|---|---|
| Age (years), mean±SD | 68.3±11.8 |
| Number of passes, mean±SD | 2.8±1.0 |
| Lesion site, n (%) | |
| Pancreatic head and uncinated process | 150 (63.6) |
| Pancreatic body | 64 (27.1) |
| Pancreatic tail | 22 (9.3) |
| Possibility to obtain histological core, n (%) | 170 (72.0) |
| Possibility to draw histological/cytological diagnosis from tissue sample (diagnostic yield), n (%) | 218 (92.4) |
| Diagnosis at EUS vs. gold standard diagnosis type, n | |
| Malignant lesion | 197/217 |
| Benign lesion | 21/19* |
| No sample or inadequate sample | 18 |
| 20G PC diagnostic performance for malignant lesions, % (95% CI) | |
| Overall accuracy | 91.5 (87.2–94.7) |
| Sensitivity | 90.8 (86.1–94.3) |
| Specificity | 100 (82.4–100) |
| PPV | 100 (98.1–100) |
| NPV | 48.7 (32.4–65.2) |
| NND | 1.1 (1.1–1.5) |
| NNM | 11.8 (7.8–18.9) |
| 20G PC-related complications, n(%) | |
| Bleeding | 1 (0.4) |
| Pain | 1 (0.4) |
*Two lesions were incorrectly diagnosed as benign at EUS-guided sampling, while were found to be malignant. PC: ProCore™, PPV: Positive predictive value, NPV: Negative predictive value, NNM: Number needed to misdiagnose, NND: Number needed to diagnose, CI: Confidence interval, EUS: Endoscopic ultrasound, SD: Standard deviation