Table 2.
Baseline characteristics and endoscopic intervention among the surviving and non-surviving groups in the derivation cohort.
| Characteristics | Survived (N = 180) | Deceased (N = 159) | P value |
|---|---|---|---|
| Male gender, n (%) | 87 (48.3%) | 86 (54.1%) | 0.290 |
| Age (years) | 64.0 ± 12.7 | 64.4 ± 12.2 | 0.794 |
| Body mass index (kg/m2) | 21.7 ± 3.4 | 21.4 ± 4.1 | 0.463 |
| Waiting time for ERCP (days) | 19.0 (9.0–30.0) | 20.0 (9.0–32.0) | 0.468 |
| Type of malignancy | |||
| Cholangiocarcinoma, n (%) | 89 (49.4%) | 92 (57.9%) | 0.121 |
| Intrahepatic cholangiocarcinoma | 14 (15.7%) | 17 (18.5%) | 0.353 |
| Hilar cholangiocarcinoma | 54 (30.0%) | 53 (62.9%) | 0.510 |
| Extrahepatic cholangiocarcinoma | 21 (23.6%) | 22 (23.9%) | 0.352 |
| Pancreatic cancer | 67 (37.2%) | 53 (33.3%) | 0.455 |
| Gallbladder cancer | 21 (11.7%) | 13 (8.2%) | 0.286 |
| Malignant IPMN | 3 (1.7%) | 1 (0.6%) | 0.626 |
| ECOG performance-status score, n (%) | |||
| 1 | 34 (18.9%) | 24 (15.1%) | 0.355 |
| 2 | 105 (58.3%) | 87 (54.7%) | 0.503 |
| 3 | 41 (22.8%) | 48 (30.2%) | 0.122 |
| Multiple comorbidities † | 61 (33.9%) | 53 (33.3%) | 0.914 |
| Clinical presentation | |||
| Abdominal pain | 97 (53.9%) | 97 (61.0%) | 0.186 |
| Jaundice | 161 (89.4%) | 142 (89.3%) | 0.968 |
| Fever | 16 (8.9%) | 8 (5.0%) | 0.167 |
| Weight loss | 102 (56.7%) | 114 (71.7%) | 0.004 |
| Ascending cholangitis | 31 (17.2%) | 30 (18.9%) | 0.694 |
| Pre-endoscopic laboratory | |||
| Hemoglobin (g/dL) | 10.7 ± 1.8 | 10.4 ± 4.0 | 0.377 |
| Platelet (109/L) | 312.5 (258–393) | 322 (268–404) | 0.430 |
| INR | 1.3 ± 0.5 | 1.5 ± 0.8 | 0.023 |
| Total bilirubin (mg/dl) | 17.5 ± 9.7 | 21.1 ± 9.0 | 0.001 |
| Albumin (g/dL) | 3.4 ± 0.6 | 3.1 ± 0.6 | < 0.001 |
| Alkaline phosphatase (IU/L) | 427.5 (270.0–647.5) | 522.0 (309.0–716.0) | 0.027 |
| Creatinine (mg/dl) | 0.8 (0.7–0.9) | 0.8 (0.6–1.0) | 0.515 |
| Cross-sectional imaging | |||
| Size of obstructive tumor (cm) | 3.9 (2.2–3.5) | 4.1 (2.8–5.8) | 0.004 |
| Hilar obstruction, n (%) | 73 (40.6%) | 60 (37.7%) | 0.596 |
| Non-hilar obstruction, n (%) | 107 (59.4%) | 99 (62.3%) | 0.596 |
| Intrahepatic obstruction | 3 (1.7%) | 11 (6.9%) | 0.015 |
| Extrahepatic obstruction | 104 (57.8%) | 88 (55.3%) | 0.652 |
| Combined obstruction, n (%) | 8 (4.4%) | 6 (3.8%) | 0.757 |
| Vascular involvement, n (%) | 80 (44.4%) | 81 (50.9%) | 0.232 |
| Portal vein invasion, n (%) | 45 (25.0%) | 51 (32.1%) | 0.149 |
| Duodenal invasion, n (%) | 16 (8.9%) | 15 (9.4%) | 0.862 |
| Liver metastasis, n (%) | 49 (27.2%) | 67 (42.1%) | 0.004 |
| Distant metastasis, n (%) | 93 (51.7%) | 112 (70.4%) | < 0.001 |
| Peritoneal carcinomatosis, n (%) | 14 (7.8%) | 27 (17.0%) | 0.010 |
| Lymph node metastasis, n (%) | 120 (66.7%) | 111 (69.8%) | 0.535 |
| Endoscopic intervention, n (%) | |||
| Length of biliary stricture (mm) | 20.0 (13.0–30.0) | 20.0 (15.0–30.0) | 0.143 |
| Diameter of intrahepatic biliary dilatation (mm) | 16.0 ± 6.5 | 16.3 ± 6.5 | 0.225 |
| Diameter of extrahepatic biliary dilatation (mm) | 17.5 ± 6.3 | 17.2 ± 6.9 | 0.765 |
| Presence of either metallic or plastic stent | 105 (58.3%)/75 (41.7%) | 114 (71.7%)/45 (28.3%) | 0.010 |
| One stent placement | 168 (93.3%) | 149 (93.7%) | 0.888 |
| One plastic stent placement | 69 (38.3%) | 43 (27.0%) | 0.027 |
| One metallic stent placement | 99 (55.0%) | 106 (66.7%) | 0.028 |
| - Uncovered SEMs | 97 (53.9%) | 102 (64.2%) | 0.055 |
| - Fully covered SEMs | 1 (0.6%) | 3 (1.9%) | 0.345 |
| - Partially covered SEMs | 1 (0.6%) | 1 (0.6%) | 1.000 |
| Two-stent placements | 12 (6.7%) | 10 (6.3%) | 0.888 |
| Two metallic stents | 5 (2.8%) | 7 (4.4%) | 0.419 |
| Two plastic stents | 6 (3.3%) | 1 (0.6%) | 0.126 |
| One metallic and one plastic stent | 1 (8.3%) | 2 (20.0%) | 0.571 |
| Post-endoscopic outcomes | |||
| Post-ERCP complications, n (%) | 15 (8.3%) | 19 (11.9%) | 0.269 |
| Post-ERCP cholangitis | 6 (3.3%) | 10 (6.3%) | 0.200 |
| Post-ERCP pancreatitis | 8 (4.4%) | 9 (5.7%) | 0.609 |
| Duodenal perforation | 0 | 0 | – |
| Post-sphincterotomy bleeding | 0 | 1 (0.6%) | 0.452 |
| Stent dysfunction, n (%) | 71 (39.4%) | 21 (13.2%) | < 0.001 |
| Stent patency time (days) | 75.5 (35.0–118.0) | 28.0 (18.0–52.0) | 0.003 |
| Bilirubin improvement after stenting‡, n (%) | 140 (77.8%) | 100 (62.9%) | 0.003 |
| Chemotherapy after ERCP, n (%) | 44 (24.4%) | 5 (3.1%) | < 0.001 |
Data are presented as the mean ± standard deviation, median (interquartile range), or number (proportion) of patients with a condition.
IPMN, intraductal papillary mucinous neoplasm; ECOG, Eastern cooperative oncology group; ERCP, endoscopic retrograde cholangiopancreatography; INR, international normalized ratio; SEMs, self-expandable metallic stent.
†Defined by more than two illnesses or diseases occurring in the same person at the same time.
‡Defined by total bilirubin improvement of more than 50% from baseline within 2 weeks after ERCP-guided endobiliary stent placement.