Table 4.
Randomized controlled trials and retrospective studies comparing covered with un-covered biliary self-expanding metal stents for malignant distal biliary obstruction
| Ref. | Year | Study design | Type of stent | No. of patients | Pancreatic malignancy (%) | Stent patency (d) | Patient survival (d) | No. of stent dysfunction | No. of complications |
| Seo et al[15] | 2019 | RCT | Uncovered, Covered | 60, 59 | 100 | NA, NA | NA, NA | 101, 0 | 12, 14 |
| Conio et al[88] | 2018 | RCT | Uncovered, Covered | 80, 78 | 72.5, 75.6 | 541 (Median)1, 240 (Median) | 112 (Median), 134 (Median) | 10, 12 | 10, 19 |
| Flores-Carmona et al[89] | 2016 | RCT | Uncovered, Covered | 46, 22 | 52.5, 50 | NA, NA | NA, NA | 4, 3 | NA, NA |
| Mangiavillano et al[90] | 2015 | RCT | Uncovered, Covered | 21, 23 | NA | 194 (Median)1, 89 (Median) | NA, NA | NA, NA | 1, 1 |
| Lee SJ et al[91] | 2014 | RCT | Uncovered, Covered | 20, 20 | 30, 60 | 413.3 ± 63 (mean ± SD)1, 207.5 ± 46 (mean ± SD) | 359.9 ± 61.5 (mean ± SD), 350.5 ± 43.8 (mean ± SD) | 41, 10 | 0, 3 |
| Ung et al[92] | 2013 | RCT | Uncovered, Covered | 34, 34 | 79, 88 | 127 (Median), 153 (Median) | 157 (Median), 154 (Median) | NA, NA | 0, 2 |
| Kitano et al[93] | 2013 | RCT | Uncovered, Covered | 60, 60 | 100, 100 | 166.9 ± 124.9 (mean ± SD)1, 219.3 ± 159.1 (mean ± SD) | 223 (Median), 285(Median) | 22, 14 | 2, 2 |
| Fukuda et al[94] | 2012 | RCT | Uncovered, Covered | 71, 72 | 84.5, 83.3 | 314 (Median)1, 552(Median) | NA, NA | 23, 17 | NA, NA |
| Krokidis et al[95] | 2011 | RCT | Uncovered, Covered | 40, 40 | 100, 100 | 166.0 ± 82.8 (mean ± SD)1, 234.0 ± 132 (mean ± SD) | 203.2 ± 74.8 (Median ± SD), 247.0 ± 126.7 (Median ± SD) | 121, 4 | 4, 5 |
| Krokidis et al[96] | 2010 | RCT | Uncovered, Covered | 30, 30 | 0, 0 | 166.0 ± 87.7 (mean ± SD)1, 227.3 ± 139.7 (mean ± SD) | 180.5 ± 82.6 (Median ± SD), 243.5.0 ± 141.1 (Median ± SD) | 101, 4 | 4, 3 |
| Kullman et al[97] | 2010 | RCT | Uncovered, Covered | 200, 200 | 77, 76 | 154 (Mean), 199 (Mean) | 174 (Median), 116 (Median) | 45, 47 | 20, 14 |
| Telford et al[98] | 2010 | RCT | Uncovered, Covered | 61, 68 | 77, 86 | 711 (Median), 357 (Median) | 239 (Median), 227 (Median) | 121, 23 | 271, 48 |
| Cho et al[99] | 2009 | RCT | Uncovered, Covered | 38, 39 | NA | 195 (Median), 227 (Median) | NA, NA | NA, NA | 4, 10 |
| Gonzalez-Huix et al[100] | 2008 | RCT | Uncovered, Covered | 53, 61 | 58.5, 52.5 | NA, NA | NA, NA | 61, 8 | 141, 23 |
| Yoon et al[46] | 2006 | Retrospective | Uncovered, Covered | 41, 36 | 68.2, 86 | 319 (Mean), 398 (Mean) | 308 ± 42 (mean ± SD), 392 ± 60 (mean ± SD) | 111, 15 | 1, 4 |
| Park et al[101] | 2006 | Retrospective | Uncovered, Covered | 108, 98 | 65.7, 54.1 | 143.5 (Mean), 148.9 (Mean) | 207 (Mean), 209 (Mean) | 20, 21 | 3, 17 |
| Isayama et al[102] | 2004 | RCT | Uncovered, Covered | 55, 57 | 58.2, 59.6 | 193 (Mean)1, 225 (Mean) | 237 (Mean), 255 (Mean) | 211, 8 | 3, 8 |
| Lee et al[103] | 2004 | RCT | Uncovered, Covered | 21, 22 | 38.1, 40.9 | 127 (Median)1, 216 (Median) | NA, NA | 11, 4 | NA, NA |
| Smith et al[105] | 1995 | RCT | Uncovered, Covered | 24, 22 | 70.1, 77.3 | NA, NA | NA, NA | NA, NA | 3, 3 |
1
Statistically significant data; RCT: Randomized controlled trial; NA: Data not available.