Table 3 Baseline characteristics of study subjects.
From: Efficacy of a newly developed guidewire for selective biliary access
N (%) | Experimental (TRUwire) (n = 191) | Control (VisiGlide 2) (n = 185) | P-value |
|---|---|---|---|
Age (mean ± SD) | 65.3 ± 14.0 | 66.7 ± 12.8 | 0.297 |
Sex | 0.627 | ||
Male/Female | 108 (56.5)/83 (43.5) | 100 (54.1)/85 (45.9) | |
Diagnosis | 0.316 | ||
CBD stone | 110 (57.6) | 110 (59.5) | |
Cholangiocarcinoma | 24 (12.6) | 30 (16.2) | |
Pancreas cancer | 15 (7.9) | 17 (9.2) | |
Metastatic biliary obstruction | 12 (6.3) | 8 (4.3) | |
Gallbladder cancer | 8 (4.2) | 3 (1.6) | |
Hepatocellular carcinoma | 4 (2.1) | 4 (2.2) | |
Ampullary cancer | 3 (1.6) | 3 (1.6) | |
Benign biliary obstruction | 6 (3.1) | 0 | |
Post-operative injury | 1 (0.5) | 1 (0.5) | |
Sphincter of Oddi dysfunction | 0 | 1 (0.5) | |
Others | 8 (4.2) | 8 (4.3) | |
Previous cholecystectomy | 25 (13.1) | 22 (11.9) | 0.725 |
Comorbid diseases, n (%) | |||
Cardiovascular | 88 (46.1) | 79 (42.7) | 0.510 |
Cerebral | 22 (11.5) | 15 (8.1) | 0.267 |
Diabetes | 48 (25.1) | 42 (22.7) | 0.581 |
Chronic kidney disease | 2 (1.0) | 9 (4.9) | 0.028 |
Liver cirrhosis | 10 (5.2) | 6 (3.2) | 0.338 |
Others | 15 (7.9) | 18 (9.7) | 0.520 |
No comorbid diseases | 63 (33.0) | 75 (40.5) | 0.128 |
Biliary obstruction level | 0.604 | ||
Perihilar | 15 (7.9) | 24 (13) | |
I/ II/ IIIA/ IIIB/ IV | 2/ 4/ 2/ 4/ 3 | 4/ 2/ 7/ 3/ 8 | |
Proximal CBD | 8 (4.2) | 7 (3.8) | |
Mid-CBD | 8 (4.2) | 8 (4.3) | |
Distal-CBD | 52 (27.2) | 49 (26.5) | |
Absent | 108 (56.5) | 97 (52.4) | |
Periampullary diverticulum | 0.432 | ||
Absent | 142 (74.3) | 129 (69.7) | |
*Type I/II/III | 15 (7.9)/ 19 (9.9)/ 15 (7.9) | 24 (13.0)/ 19 (10.3)/ 13 (7.0) | |
CBD diameter, mm (mean ± SD) | 12.1 ± 4.8 | 11.7 ± 4.6 | 0.433 |
Papillary shape | 0.290 | ||
Non-prominent | 113 (59.2) | 105 (56.8) | |
Prominent | 51 (26.7) | 54 (29.2) | |
Bulging hooknose | 13 (6.8) | 19 (10.3) | |
Distorted | 14 (7.3) | 7 (3.8) | |
Initial lab | |||
Total bilirubin, median (IQR) | 1.5 (0.6–4.5) | 2.1 (0.8–6.1) | 0.062 |
Hb, mean ± SD | 12.7 ± 2.1 | 12.3 ± 1.7 | 0.061 |
ALT, median (IQR) | 84.0 (29.0–217.0) | 105.0 (41.0–264.0) | 0.110 |
Amylase, median (IQR) | 46.0 (30.0–72.0) | 51.0 (32.0–84.0) | 0.155 |
Lipase, median (IQR) | 38.5 (27.0–69.0) | 46.0 (31.0–72.0) | 0.077 |
