Table 4. EUS-IBD versus percutaneous biliary drainage for patients with proximal stenosis or post-surgical anatomy.
| Variable | EUS-IBD (N = 45) | PTBD (N = 45) | P value |
| Matched variables | |||
| Proportion of malignant indication, n (%) | 40 (88.9 %) | 40 (88.9 %) | 1 |
| Level of the stenosis, n (%) | 1 | ||
| Anastomotic | 15 (33.3 %) | 15 (33.3 %) | |
| Hilar/Intrahepatic | 30 (66.7 %) | 30 (66.7 %) | |
| “Disconnected ductal system”, n (%) | 26 (57.8 %) | 26 (57.8 %) | 1 |
| Age [IQR], years | 67 [60.5 – 76] | 67 [62.3 – 74.5] | 0.96 |
| Other Variables | |||
| Male sex | 23 (51.1 %) | 30 (66.7 %) | 0.1 |
| Previous failed ERCP | 18 (40 %) | 18 (40 %) | 1 |
| Previous biliary drainage | 17 (38.6 %) | 8 (17.8 %) | 0.03 1 |
| Median bilirubin [IQR], mg/dl | 5.1 [2.6 – 10.2] | 8.3 [2.9 – 13.3] | 0.2 |
| Efficacy | |||
| Technical success, n (%) | 42 (93.3 %) | 44 (97.8 %) | 0.31 |
| Available FU | N = 39 | N = 44 | |
| Clinical success, n (%) | 38 (97.4 %) | 35 (79.5 %) | 0.01 1 |
| Median bilirubin decrease [IQR], mg/dL 2 | 2.6 [1.2 – 5.2] (N = 33) | 4.2 [0.9 – 7] (N = 39) | 0.64 |
| Time to bilirubin decrease [IQR], days 2 | 7 [5 – 11] | 6 [3 – 16] | 0.44 |
| Bilirubin decrease ≥ 25 %, n (%) 2 | 30 /33 (90.9 %) | 31 /39 (79.5 %) | 0.18 |
| Bilirubin decrease ≥ 50 %, n (%) 2 | 18 /33 (54.5 %) | 20 /39 (51.3 %) | 0.78 |
| Procedural time [IQR], minutes | 35 [24.8 – 60.3] | 45 [28.5 – 69.5] | 0.23 |
| Median hospital stay [IQR], days | 7.5 [2 – 10] (N = 34) | 11.5 [7 – 21.5] (N = 44) | 0.01 1 |
| Safety | 0.004 1 | ||
| No post-procedural event, n (%) | 29 (64.4 %) | 14 (31.1 %) | |
| Mild post-procedural pain, n (%) | 8 (17.8 %) | 20 (44.4 %) | |
| Adverse events, n (%) | 8 (17.8 %) | 11 (24.4 %) | |
| Severe adverse events, n (%) | 1 (2.2 %) | 0 (0 %) | 0.32 |
| Follow-up | |||
| Stent dysfunction, n (%) 3 | 6 /38 (15.8 %) | 15 /35 (42.9 %) | 0.01 1 |
| Median time to dysfunction [IQR], days | 118 [77 – 196] | 81 [20 – 157] | 0.31 4 |
| Median number of reinterventions [IQR] | 0 [0 – 0] | 1 [0.25 – 3], | < 0.0001 1 |
| Median post-procedural survival (95 %CI) 5 , days | 91 (95 %CI 50 – 168) | 119 (95 %CI 77 – 250) | 0.61 5 |
EUS-IBD, endoscopic ultrasound-guided intrahepatic biliary drainage; PTBD, percutaneous biliary drainage; IQR, interquartile range; ERCP, endoscopic retrograde cholangiopancreatography.
1
Statistically significant
2
Per-protocol; among patients with available data and pre-procedural elevation
3
Per-protocol; among patients with clinical success and available follow-up
4
N differences in dysfunction-free survival at log-rank test ( P = 0.56)
5
Based on the log-rank test at Kaplan-Meier statistics.