Table 4 Main procedure outcomes (Intention-To-Treat and Per-Protocol analysis).
From: Efficacy of a newly developed guidewire for selective biliary access
N (%) | Experimental (n = 191) | Control (n = 185) | Difference in proportion (%)(two-sided 95% CI) | P-value† | P-value‡ | ||
|---|---|---|---|---|---|---|---|
Technical success of primary WGC | 151 (79.1) | 131 (70.8) | 8.25 (− 0.48–16.98) | < .001 | 0.064 | ||
Technical success including cross-over | 156 (81.7) | 126 (68.1) | 13.57% (4.90–22.24) | < .001 | 0.002 | ||
Technical success of primary WGC (PP) | 151/153 (98.7) | 131/132 (99.2) | − 0.55% (− 2.88–1.78) | < .001 | 1.000 | ||
Technical success including cross-over (PP) | 152 (99.3) | 130 (98.5) | 0.86% (− 1.58–3.31) | < .001 | 0.597 | ||
Overcoming methods in difficult cannulation | |||||||
Precut fistulotomy | 22 (11.5) | 32 (17.3) | 0.110 | ||||
Double-guidewire cannulation | 1 (0.5) | 3 (1.6) | 0.365 | ||||
Biliary access after PD | 16 (8.4) | 23 (12.4) | 0.197 | ||||
Overall cannulation success | 186 (97.4) | 181 (97.8) | − 0.46 (− 3.54–2.63) | < .0001 | 1.000 | ||
Cannulation method | 0.908 | ||||||
Conventional cannula | 65 (34) | 64 (34.6) | |||||
Papillotome | 126 (66) | 121 (65.4) | |||||
Frequency of papillary contacts, median (IQR) [range] | 2 (1–4) [1, 20] | 2 (1–4) [1, 16] | 0.240 | ||||
Cannulation time°, median (IQR) [range] | 53 (22–180) [3, 1506] | 77 (30–240) [1, 2848] | 0.047 | ||||
Cannulation time°, median (IQR) [range] (PP) | 42 (20–115) [3, 400] | 45 (23–115) [1, 833] | 0.446 | ||||
Total procedure time*, median (IQR) [range] | 545 (360–927) [120, 3610] | 562 (400–900) [180, 3514] | 0.420 | ||||
GW looping during cannulation | 0.244 | ||||||
None | 125 (65.4) | 131 (70.8) | |||||
in CBD | 66 (34.6) | 53 (28.6) | |||||
in PD | 0 | 1 (0.5) | |||||
GW type | Straight | Angled | Straight | Angled | 0.868 | ||
78 (40.8) | 113 (59.2) | 74 (40) | 110 (60) | ||||
Technical success of primary WGC | 65 (83.3) | 86 (76.1) | 56 (75.7) | 75 (67.6) | 0.100 | ||
DBC, difficult biliary cannulation | 24 (30.8) | 42 (37.2) | 36 (48.6) | 57 (51.4) | 0.015 | ||
