Table 1.
Patient characteristics at baseline
| Characteristic | Partially covered SEMS (n = 42) | 10-French polyethylene plastic stent (n = 43) | P value | |
| Gender (male) | 51.2% | 50.0% | 0.9119 | |
| Age (yr) | 70.8 ± 12.9 | 73.3 ± 10.7 | 0.3896 | |
| Co-morbidities: | Cardiovascular | 53.7% | 47.5% | 0.5676 |
| Respiratory | 22.0% | 20.0% | 0.8209 | |
| Neurologic | 19.5% | 22.5% | 0.7343 | |
| GI, liver, biliary | 75.6% | 77.5% | 0.8362 | |
| Renal, urinary | 15.0% | 30.0% | 0.0982 | |
| Musculoskeletal | 25.0% | 35.0% | 0.3148 | |
| Endocrine | 47.5% | 30.0% | 0.0976 | |
| Cholestatic symptoms | 97.5% | 100.0% | 0.2968 | |
| Jaundice | 85.4% | 97.5% | 0.0453 | |
| Clay-colored stools | 36.6% | 52.5% | 0.1404 | |
| Abdominal pain | Abdominal pain | 53.7% | 40.0% | 0.2056 |
| Pruritus | 51.2% | 50.0% | 0.9119 | |
| Dark urine | 75.6% | 75.0% | 0.9489 | |
| Fever | Fever | 9.8% | 5.0% | 0.3972 |
| Constitutional symptoms | ||||
| Weight Loss | 73.2% | 47.5% | 0.0155 | |
| Anorexia | 51.2% | 50.0% | 0.9119 | |
| Obstruction location | Papilla | 2.78% | 7.9% | 0.2951 |
| Distal common bile duct | 72.2% | 47.4% | 0.0198 | |
| Mid common bile duct | 22.2% | 39.5% | 0.0845 | |
| Proximal common bile duct | 2.8% | 5.3% | 0.5595 | |
| Type of primary tumor | Ampullary carcinoma | 2.6% | 7.5% | 0.3036 |
| Cholangiocarcinoma | 0.0% | 5.0% | 0.1422 | |
| Gallbladder adenocarcinoma | 2.6% | 2.5% | 0.9767 | |
| Metastatic Cancer | 10.3% | 7.5% | 0.6501 | |
| Pancreatic adenocarcinoma | 69.2% | 67.5% | 0.8662 | |
| Other | 0.0% | 2.5% | 0.3024 | |
| Unknown | 15.4% | 7.5% | 0.2519 | |
| Metastat. cancer prim. location | Colon | 28.6% | 0.0% | 0.0002 |
| Lung | 28.6% | 20.0% | 0.355 | |
| Other | 42.9% | 80.0% | 0.0004 | |
| Tumor stage | T1 | 4.0% | 19.2% | 0.0292 |
| T2 | 32.0% | 11.5% | 0.0217 | |
| T3 | 16.0% | 42.3% | 0.0077 | |
| T4 | 48.0% | 26.9% | 0.0443 | |
| Nodes | N0 | 36.4% | 61.9% | 0.0187 |
| N1 | 63.6% | 38.1% | 0.0187 | |
| Metastatic tumor | M0 | 29.2% | 36.0% | 0.5038 |
| M1 | 70.8% | 64.0% | 0.5038 | |
| Chemotherapy or radiation | 11.1% | 8.82% | 0.7255 | |
| Laboratory data | Alkaline phosphatase (IU/L) | 630.5 ± 347.7 | 532.7 ± 331.4 | 0.1486 |
| Bilirubin (mg/dL) | 9.56 ± 6.99 | 11.33 ± 7.82 | 0.3082 | |
| Hematocrit | 43.97% ± 50.36% | 37.06% ± 5.95% | 0.3280 | |
| Hemoglobin (g/dL) | 12.01 ± 1.63 | 12.39 ± 2.09 | 0.3305 | |
| INR | 1.17 ± 0.19 | 1.25 ± 0.36 | 0.5922 | |
| AST (IU/L) | 168.64 ± 98.34 | 191.26 ± 149.25 | 0.6687 | |
| ALT (IU/L) | 240.03 ± 178.35 | 265.03 ± 240.48 | 0.8926 | |
| Karnosky performance scores | 81.8 ± 10.8 | 82.0 ± 12.03 | 0.9151 |
SEMS: Self-expandable metal stent; INR: International normalized ratio; AST: Aspartate aminotransferase; ALT: Alkaline phosphatase.