Clinicopathological characteristics of training and validation cohorts based on the absence (negative) versus presence (positive) of genomic alterations
| Patient or bile duct characteristics | Total, n=252 | Training cohort | Validation cohort | ||||
| Negative (n=35, 61%) | Positive (n=22, 39%) | P value | Negative (n=104, 53%) | Positive (n=91, 47%) | P value | ||
| Gender | |||||||
| Female | 112 | 17 (63) | 10 (37) | 1.000 | 47 (55) | 38 (45) | 0.666 |
| Male | 140 | 18 (60) | 12 (40) | 57 (52) | 53 (48) | ||
| Mean age (range), years | 67.2 (15–96) | 65.5 (26–96) | 68.7 (51–92) | 0.469 | 64.3 (15–89) | 71.0 (33–96) | <0.001 |
| History of PSC | 41 | 8 (67) | 4 (33) | 0.750 | 23 (79) | 6 (21) | 0.002 |
| CA 19–9≥44 U/mL (n=218)* | 134 | 10 (47) | 16 (53) | 0.002 | 47 (44) | 61 (56) | 0.013 |
| CA 19–9>129 U/mL (n=218)* | 96 | 6 (32) | 13 (68) | 0.002 | 28 (36) | 49 (64) | 0.001 |
| Location of stricture | |||||||
| Intrahepatic | 38 | 9 (60) | 6 (40) | 1.000 | 13 (57) | 10 (43) | 0.219 |
| Hilar | 47 | 7 (58) | 5 (42) | 14 (40) | 21 (60) | ||
| Distal | 167 | 19 (63) | 11 (37) | 77 (56) | 60 (44) | ||
| Malignant biliary brushing/biopsy† | 74 | 5 (31) | 11 (69) | 0.006 | 12 (21) | 46 (79) | <0.001 |
| Clinical and diagnostic pathology follow-up | n=220 | n=35 | n=22 | n=76 | n=87 | ||
| Intrahepatic cholangiocarcinoma | 22 | 0 (0) | 5 (100) | <0.001† | 5 (29) | 12 (17) | <0.001† |
| Perihilar cholangiocarcinoma | 26 | 5 (42) | 7 (58) | 3 (21) | 11 (79) | ||
| Distal cholangiocarcinoma | 47 | 6 (50) | 6 (50) | 11 (31) | 24 (69) | ||
| Mixed HCC-cholangiocarcinoma | 1 | – | – | 0 (0) | 1 (100) | ||
| Pancreatic ductal adenocarcinoma | 33 | 0 (0) | 3 (100) | 6 (20) | 24 (80) | ||
| Gallbladder adenocarcinoma | 11 | 2 (67) | 1 (33) | 3 (37) | 5 (63) | ||
| Ampullary adenocarcinoma | 7 | – | – | 0 (0) | 7 (100) | ||
| Metastatic colonic adenocarcinoma | 1 | – | – | 0 (0) | 1 (100) | ||
| High-grade biliary dysplasia | 2 | – | – | 0 (0) | 2 (100) | ||
| Benign cholangiopathy | 70 | 22 (100) | 0 (0) | 48 (100) | 0 (0) | ||
*Serum CA19-9 was measured for 218 of 252 (87%) patients.
†Malignant biliary brushing/biopsy is defined as at least high-grade dysplasia/suspicious for adenocarcinoma.
CA19-9, carbohydrate antigen 19–9; HCC, hepatocellular carcinoma; PSC, primary sclerosing cholangitis.