Table 3. Comparison of the three EUS-IBD techniques.
| Variable | e-RV (N = 16) | e-AS (N = 45) | e-HG (N = 43) | P value |
| Clinical indication | ||||
| Proportion of malignant indication, n (%) | 8 (50 %) | 41 (91.1 %) | 38 (88.4 %) | 0.0004 1 |
| Level of the stenosis, n (%) | < 0.0001 1 | |||
| None (choledocholithiasis) | 6 (37.5 %) | 0 | 0 | |
| Distal | 9 (56.2 %) | 32 (71.1 %) | 11 (25.6 %) | |
| Hilar/intrahepatic | 1 (6.2 %) | 8 (17.8 %) | 22 (51.2 %) | |
| Anastomotic (after surgical hepatico-enterostomy) | 0 | 5 (11.1 %) | 10 (23.3 %) | |
| Reason for the transgastric approach, n (%) | 0.01 1 | |||
| Surgery impeding access to papillary region | 0 | 9 (20 %) | 14 (32.6 %) | |
| Papillary region inaccessible for stenosis/infiltration | 4 (25 %) | 22 (48.9 %) | 9 (20.9 %) | |
| Failed ERCP cannulation | 12 (75 %) | 14 (31.1 %) | 19 (44.2 %) | |
| Successful ERCP but unnegotiable stenosis | 0 | 0 | 1 (2.3 %) | |
| “Disconnected ductal system”, n (%) | 1 (6.2 %) | 3 (6.7 %) | 23 (53.5 %) | < 0.0001 1 |
| Efficacy | ||||
| Technical success, n (%) | 0.04 1 | |||
| Successful access and complete treatment | 10 (62.5 %) | 39 (86.7 %) | 38 (88.4 %) | |
| Successful biliary cannulation but uncomplete procedure | 2 (12.5 %) | 4 (8.9 %) | 0 | |
| Technical failure, n (%) | 4 (25 %) | 2 (4.4 %) | 5 (11.6 %) | |
| Clinical success, n (%) | 8/8 (100 %) | 32/33 (97 %) | 36/38 (94.7 %) | 0.74 |
| Bilirubin decrease ≥ 25 %, n (%) 2 | 2/3 (66.7 %) | 28/29 (96.6 %) | 27/31 (87.1 %) | 0.16 |
| Bilirubin decrease ≥ 50 %, n (%) 2 | 2/3 (66.7 %) | 26/29 (89.7 %) | 16/31 (51.6 %) | 0.01 1 |
| Stent dysfunction, n (%) 3 | 0/4 (0 %) | 4/32 (12.5 %) | 7/35 (20 %) | 0.47 |
| Median time to dysfunction [IQR], days 3 | – | 101 [49.5 – 147.5] | 96 [51.5 – 182] | 0.71 4 |
| Safety | ||||
| Acute increase of inflammatory markers, n (%) 5 | 4/6 (66.7 %) | 23/26 (88.5 %) | 21/31 (67.7 %) | 0.16 |
| Adverse events, n (%) | 0.83 | |||
| Mild abdominal pain | 3/15 (20 %) | 7/45 (15.6 %) | 9/43 (20.9 %) | |
| Any adverse events | 2/15 (13.3 %) | 11/45 (24.4 %) | 11/43 (25.6 %) | |
| Severe adverse events | 0/2 (0 %) | 2/11 (18.2 %) | 2/11 (18.2 %) | 0.8 |
| Median post-procedural survival [IQR], days | 76 [59.8 – 428.8] | 61 [39 – 185] | 50 [24.3 – 156] | 0.24 6 |
EUS-IBD, endoscopic ultrasound-guided intrahepatic biliary drainage; IQR, interquartile range; EUS, endoscopic ultrasound; ERCP, endoscopic retrograde cholangiopancreatography
1
Statistically significant
2
Per-protocol; among patients with pre-procedural bilirubin elevation
3
Per-protocol; among patients with biliary stenosis and successful stent placement
4
No different probability of dysfunction-free survival at log-rank test (p = 0.1908)
5
Among patients with technical success
6
Higher probability of survival among patients undergoing e-RV versus e-AG (HR = 2 [1.1 – 3.6]) and e-HG (HR = 2.1 [1.1 – 3.9]); log-rank test ( P = 0.1186)