Table 4. Summary of the studies published as full papers reporting > 2 cases of EUS-guided biliary drainage after failed or not possible ERCP using the Axios stent in patients with distal malignant biliary obstruction.
| Author (year) | Study type | No. of patients | A × ios stents used | Stent size (diameter × length) (mm) | Mean CBD diameter (mm) | Technical success (%) | Clinical success (%) | Mean Follow-up (days) | AEs (number of cases, %) | |
| “Hot” | “Cold” | |||||||||
| Brückner (2015) 10 | RS, SC | 5 | 3 | 2 | 6 × 8 in all | 12.6 ± 3 | 5/5 1 (100) | 5/5 (100) | 9.8 ± 6.8 | 1/5 (20 %): stent dysfunction (1) |
| Anderloni (2016) 11 | CS, SC | 5 2 | 5 | 0 | NR | NR | 5/5 (100) | 5/5 (100) | 7 | NR |
| Kunda (2016) 9 | RS, MC | 57 | 30 | 27 | 6 × 8 in 36 | 17.9 (range 8–35) (median) | 56/57 3 (98.2) | 54/56 (96.4) | 151 ± 145 | 8/56 (14.3 %): duodenal perforation (1); stent migration (1); intraprocedural bleeding (1); transient cholangitis (1); stent occlusion or dysfunction (4) |
| 8 × 8 in 2 | ||||||||||
| 10 × 10 in 16 | ||||||||||
| 15 × 10 in 2 | ||||||||||
| Anderloni (2018) 13 | RS, SC | 16 4 | 16 | 0 | 6 × 8 in 9 | NR | 15/16 (93.8) | 14/15 (93.3) | 138.7 ± 124.6 | 1/15 (6.7 %): fatal severe acute arterial bleeding (1) |
| 8 × 8 in 4 | ||||||||||
| 10 × 10 in 3 | ||||||||||
| Tsuchiya (2018) 14 | PS, MC | 19 | 19 | 0 | 6 × 8 in 10 | 17.3 ± 5.5 | 19/19 (100) | 18/19 (94.7) | 184 (range 12–819) (median) |
7/19 (36.8 %): fever (1); cholangitis (2, in 1 after stent obstruction); stent dysfunction/obstruction (3); stent dislodgement (1) |
| 8 × 8 in 9 | ||||||||||
| Puga (2019) 15 | PS, SC | 7 | 7 | 0 | 6 × 8 in 6 | NR | 7/7 (100) | 5/8 5 (62.5) | 66 6 (95 % CI, 7–127) | 2/7 (28.6 %): fatal bleeding (2) |
| 8 × 8 in 1 | ||||||||||
| Jacques (2019) 16 | RS, MC | 52 7 | 52 | 0 | 6 × 8 in 43 | 17.2 (range 9–25) (median) | 46/52$ (88.5) | 46/46 (100 %) | 155 | 7/46 (15.2 %): cholangitis caused by obstruction or dysfunction of the stent in all |
| 8 × 8 in 7 | ||||||||||
| 15 × 10 in 2 | ||||||||||
| Anderloni (2019) 17 | RS, SC | 46 4 | 46 | 0 | 6 × 8 in 21 | 17.3 ± 3.3 | 43/46 (93.5) | 42/43 (97.7) | 114.4 (95 % CI, 73.2–155.4) | 5/43 (11.6 %): fatal bleeding (1); stent occlusion (3); stent migration (1) |
| 8 × 8 in 19 | ||||||||||
| 10 × 10 in 6 | ||||||||||
| El Chafic (2019) 18 | RS, MC | 67 | 67 | 0 | 10 × 10 in all | 17.6 ± 3.6 | 64/67 (95.5) | 40/40 8 (100 %) | 119 (median) | 11/64 (17.2 %) 9 : abdominal pain (2); peritonitis (1); bleeding (1); stent dysfunction/obstruction (7) |
| Fabbri (2019) 19 | CS, SC | 5 10 | 5 | 0 | 8 × 8 in 4 | 20.2 ± 5.7 | 5/5 (100) | 5/5 (100) | 34.6 ± 8.1 | None related to the procedure |
| 10 × 10 in 1 | ||||||||||
| Jacques (2020) 20 | RS, MC | 70 | 70 | 0 | 6 × 8 in 60 | 17.7 ± 5.0 | 69/70 (97.1) | 69/69 (100 %) | 153 (median) | 8/69 (11.6 %): bleeding due to fistulotomy (1); stent migration (1); cholangitis (2, in 1 after stent occlusion); tumoral stent obstruction (4) |
| 8 × 8 in 9 | ||||||||||
| 15 × 10 in 1 | ||||||||||
CBD, common bile duct; AEs, adverse events; RS, retrospective study; SC, single center; MC, multicenter; CS, case series; PS, prospective study; NR, not reported; EUS-CDS, EUS-guided choledochoduodenostomy; LA-SEMS, lumen-apposing self-e × pandable metal stents.
In one of the patients, the distal flange release failed technically, but the stent system was successfully e × changed for a second system over the guidewire.
Patients in this case series presented simultaneous duodenal and biliary malignant obstruction and were treated by single-session sequential EUS-guided choledochoduodenostomy and duodenal stenting.
The technical failure was due to duodenal perforation occurring while performing dilation of the fistulous tract;
It is possible that some of the patients were reported in both studies.
Patients were reported as a cohort of eight including one patient in whom EUS-guided hepaticogastrostomy with a plastic stent was performed, and clinical success was not presented separately for the LA-SEMS stents.
All patients died during follow-up.
One of the patients presented with benign biliary obstruction (CBD stones).
Only 40 patients who were followed-up for more than 4 weeks were considered for this end point.
Biliary reinterventions for obstruction were needed in 7 (17.5 %), in 3 of 6 patients who underwent EUS-CDS with LA-SEMS alone versus 4 of 34 with LA-SEMS plus an a × is-orienting device.
In this case series, choledochoduodenostomy was performed as a bridge to surgery since all patients presented with malignancy causing biliary obstruction in a resectable stage.