Table 2.
Clinical outcomes of self-expandable metal stent insertion.
| Variable | Total | ND-GWI group | D-GWI group | p |
|---|---|---|---|---|
| N = 509 | N = 456 | N = 53 | ||
| Guidewire insertion success, n/N (%) | ||||
| ITT analysis | 491/509 (96.5) | 456/456 (100) | 35/53 (66.0) | <0.001 |
| PP analysis | 491/498 (98.6) | 456/456 (100) | 35/42 (83.3) | <0.001 |
| Technical success, n (%) | ||||
| ITT analysis | 487/509 (95.7) | 454/456 (99.7) | 33/53 (62.3) | <0.001 |
| PP analysis | 487/498 (97.8) | 454/456 (99.7) | 33/42 (78.6) | <0.001 |
| Clinical success, n (%) | ||||
| ITT analysis | 468/509 (91.9) | 438/456 (96.1) | 30/53 (56.6) | <0.001 |
| PP analysis | 468/498 (94.0) | 438/456 (96.1) | 30/42 (71.4) | <0.001 |
| Complication, n (%) | 24/509 (4.7) | 20/456 (4.4) | 4/53 (7.5) | 0.304 |
| Perforation | 2/509 (0.4) | 1/456 (0.2) | 1/53 (1.9) | – |
| Reobstruction | 7/509 (1.4) | 6/456 (1.3) | 1/53 (1.9) | – |
| Stent migration | 1/509 (0.2) | 1/456 (0.2) | 0 | – |
| Bleeding | 14/509 (2.7) | 12/456 (2.6) | 2/53 (3.8) | – |
ND-GWI group, non-difficult guidewire insertion group; D-GWI, difficult guidewire insertion group; ITT, intention-to-treat analysis; PP, per-protocol analysis.