From: Risk stratification of clinically relevant delayed gastric emptying after pancreaticoduodenectomy
Variable n (%) or median (IQR) | Whole cohort (n = 422) | without CR-DGE (n = 328) | with CR-DGE (n = 94) | P-value | Randomization (3:1 ratio) | P-value | |
---|---|---|---|---|---|---|---|
Development set (n = 317) | Validation set (n = 105) | ||||||
Age, years | 62.0 (52.0–67.0) | 62.0 (52.0–67.0) | 60.0 (51.8–66.3) | 0.937 | 61.0 (52.0–67.0) | 63 (55–68) | 0.299 |
Sex | Â | Â | Â | 0.296 | Â | Â | 0.195 |
 Male | 236 (55.9%) | 179 (54.6%) | 57 (60.6%) |  | 134 (42.3%) | 52 (49.5%) |  |
 Female | 186 (44.1%) | 149 (45.4%) | 37 (39.4%) |  | 183 (57.7%) | 53 (50.5%) |  |
BMI ≥ 22.1 kg/m2 |  |  |  | 0.011 |  |  | 0.783 |
 No | 164 (38.9%) | 138 (42.1%) | 26 (27.7%) |  | 122 (38.5%) | 42 (40%) |  |
 Yes | 258 (61.1%) | 190 (57.9%) | 68 (72.3%) |  | 195 (61.5%) | 63 (60%) |  |
Hypertension | Â | Â | Â | 0.645 | Â | Â | 0.263 |
 No | 291 (69.0%) | 228 (69.5%) | 63 (67.0%) |  | 214 (67.5%) | 77 (73.3%) |  |
 Yes | 131 (31.0%) | 100 (30.5%) | 31 (33.0%) |  | 103 (32.5%) | 28 (26.7%) |  |
Diabetes mellitus | Â | Â | Â | 0.506 | Â | Â | 0.817 |
 No | 325 (77.0%) | 255 (77.7%) | 70 (74.5%) |  | 245 (77.3%) | 80 (76.2%) |  |
 Yes | 97 (23.0%) | 73 (22.3%) | 24 (25.5%) |  | 72 (22.7%) | 25 (23.8%) |  |
Coronary heart disease | Â | Â | Â | 0.803 | Â | Â | 0.061 |
 No | 393 (93.1%) | 306 (93.3%) | 87 (92.6%) |  | 291 (91.8%) | 102 (97.1%) |  |
 Yes | 29 (6.9%) | 22 (6.7%) | 7 (7.4%) |  | 26 (8.2%) | 3 (2.9%) |  |
Cerebrovascular disease | Â | Â | Â | 0.628 | Â | Â | 0.741 |
 No | 395 (93.6%) | 306 (93.3%) | 89 (94.7%) |  | 296 (93.4%) | 99 (94.3%) |  |
 Yes | 27 (6.4%) | 22 (6.7%) | 5 (5.3%) |  | 21 (6.6%) | 6 (5.7%) |  |
Chronic gastropathy | Â | Â | Â | 0.027 | Â | Â | 0.357 |
 No | 380 (90.0%) | 301 (91.8%) | 79 (84.0%) |  | 283 (89.3%) | 97 (92.4%) |  |
 Yes | 42 (10.0%) | 27 (8.2%) | 15 (16.0%) |  | 34 (10.7%) | 8 (7.6%) | |
Pancreatitis | Â | Â | Â | 0.478 | Â | Â | 0.561 |
 No | 397 (94.1%) | 310 (94.5%) | 87 (92.6%) |  | 297 (93.7%) | 100 (95.2%) |  |
 Yes | 25 (5.9%) | 18 (5.5%) | 7 (7.4%) |  | 20 (6.3%) | 5 (4.8%) |  |
Neoadjuvant chemotherapy | Â | Â | Â | 0.524 | Â | Â | 0.533 |
 No | 408 (96.7%) | 318 (97.0%) | 90 (95.7%) |  | 305 (96.2%) | 103 (98.1%) |  |
 Yes | 14 (3.3%) | 10 (3.0%) | 4 (4.3%) |  | 12 (3.8%) | 2 (1.9%) |  |
ASA classification | Â | Â | Â | 0.519 | Â | Â | 0.673 |
 1 | 28 (6.6%) | 20 (6.1%) | 8 (8.5%) |  | 23 (7.3%) | 5 (4.8%) |  |
 2 | 323 (76.6%) | 250 (76.2%) | 73 (77.7%) |  | 241 (76.0%) | 82 (78.1%) |  |
 3 | 71 (16.8%) | 58 (17.7%) | 13 (13.8%) |  | 53 (16.7%) | 18 (17.1%) |  |
Tumor location | Â | Â | Â | 0.722 | Â | Â | 0.069 |
 Pancreatic | 277 (65.6%) | 219 (66.8%) | 58 (61.7%) |  | 197 (62.1%) | 80 (76.2%) |  |
 Duodenum | 47 (11.1%) | 34 (10.4%) | 13 (13.8%) |  | 38 (12%) | 9 (8.6%) |  |
 Common bile duct | 46 (11.0%) | 35 (10.7%) | 11 (11.7%) |  | 39 (12.3%) | 7 (6.7%) |  |
 Vater’s ampulla | 52 (12.3%) | 40 (12.3%) | 12 (12.8%) |  | 43 (13.6%) | 9 (8.6%) |  |
Malignant tumor | Â | Â | Â | 0.840 | Â | Â | 0.815 |
 No | 93 (22.0%) | 73 (22.3%) | 20 (21.3%) |  | 69 (21.8%) | 24 (22.9%) |  |
 Yes | 329 (78.0%) | 255 (77.7%) | 74 (78.7%) |  | 248 (78.2%) | 81 (77.1%) |  |
Preoperative biliary drainage | Â | Â | Â | 0.125 | Â | Â | 0.541 |
 No, with normal TB | 253 (60.0%) | 188 (57.3%) | 65 (69.1%) |  | 187 (59.0%) | 67 (63.8%) |  |
 No, TB < 200 μmol/L | 53 (12.5%) | 45 (13.7%) | 8 (8.5%) |  | 42 (13.2%) | 10 (9.5%) |  |
 Yes, TB ≥ 200 μmol/L | 116 (27.5%) | 95 (29.0%) | 21 (22.4%) |  | 88 (27.8%) | 28 (26.7%) |  |
Preoperative Gastro-intestinal decompression | Â | Â | Â | 0.619 | Â | Â | 0.642 |
 No | 416 (98.6%) | 324 (98.8%) | 92 (97.9%) |  | 313 (98.7%) | 103 (98.1%) |  |
 Yes | 6 (1.4%) | 4 (1.2%) | 2 (2.1%) |  | 4 (1.3%) | 2 (1.9%) |  |
Serum albumin ≤ 38, g/L |  |  |  | 0.166 |  |  | 0.795 |
 No | 379 (89.8%) | 291 (88.7%) | 88 (93.6%) |  | 284 (89.6%) | 95 (90.5%) |  |
 Yes | 43 (10.2%) | 37 (11.3%) | 6 (6.4%) |  | 33 (10.4%) | 10 (9.5%) | |
Abnormal liver function | Â | Â | Â | 0.361 | Â | Â | 0.399 |
 No | 198 (46.9%) | 150 (45.7%) | 48 (51.1%) |  | 145 (45.7%) | 53 (50.5%) | |
 Yes | 224 (53.1%) | 178 (54.3%) | 46 (48.9%) |  | 172 (54.3%) | 52 (49.5%) | |
Blood loss ≥ 575 ml |  |  |  | 0.201 |  |  | 0.933 |
 No | 292 (69.2%) | 232 (70.7%) | 60 (63.8%) |  | 219 (69.1%) | 73 (69.5%) |  |
 Yes | 130 (30.8%) | 96 (29.3%) | 34 (36.2%) |  | 98 (30.9%) | 32 (30.5%) |  |
Plasma transfusion ≥ 400 ml |  |  |  | 0.018 |  |  | 0.458 |
 No | 285 (67.5%) | 231 (70.4%) | 54 (57.4%) |  | 211 (66.6%) | 74 (70.5%) |  |
 Yes | 137 (32.5%) | 97 (29.6%) | 40 (42.6%) |  | 106 (33.4%) | 31 (29.5%) |  |
RBC transfusion ≥ 1U |  |  |  | 0.064 |  |  | 0.940 |
 No | 272 (64.5%) | 219 (66.8%) | 53 (56.4%) |  | 204 (64.4%) | 68 (64.8%) |  |
 Yes | 150 (35.5%) | 109 (33.2%) | 41 (43.6%) |  | 113 (35.6%) | 37 (35.2%) |  |
Operation time, hour | 6.0 (5.0–7.0) | 5.9 (5.0–6.9) | 6.1 (5.1–7.2) | 0.235 | 6.0 (5.0–7.0) | 6.0 (5.1–7.1) | 0.237 |
Intraoperative fluid input, ml | 3900 (3300–4700) | 3900 (3300–4700) | 4200 (3275–4900) | 0.361 | 3900 (3300–4700) | 4000 (3200–4850) | 0.992 |
Pylorus – preserving |  |  |  | 0.350 |  |  | 0.540 |
 No | 346 (82.0%) | 272 (82.9%) | 74 (78.7%) |  | 262 (82.6%) | 84 (80%) |  |
 Yes | 76 (18.0%) | 56 (17.1%) | 20 (21.3%) |  | 55 (17.4%) | 21 (20%) |  |
Gastrointestinal anastomosis | Â | Â | Â | 0.003 | Â | Â | 0.866 |
 Side-to-side | 210 (49.8%) | 176 (53.7%) | 34 (36.2%) |  | 157 (49.5%) | 53 (50.5%) |  |
 End-to-side | 212 (50.2%) | 152 (46.3%) | 60 (63.8%) |  | 160 (50.5%) | 52 (49.5%) |  |
MIPD | Â | Â | Â | 0.008 | Â | Â | 0.757 |
 No | 325 (77.0%) | 243 (74.1%) | 82 (87.2%) |  | 246 (77.6%) | 83 (79%) |  |
 Yes | 97 (23.0%) | 85 (25.9%) | 12 (12.8%) |  | 71 (22.4%) | 22 (21%) |  |
Braun’s anastomosis |  |  |  | 0.306 |  |  | 0.453 |
 No | 389 (92.2%) | 300 (91.5%) | 89 (94.7%) |  | 294 (92.7%) | 95 (90.5%) |  |
 Yes | 33 (7.8%) | 28 (8.5%) | 5 (5.3%) |  | 23 (7.3%) | 10 (9.5%) |  |
Vascular reconstruction | Â | Â | Â | 0.720 | Â | Â | 0.662 |
 No | 394 (93.4%) | 307 (93.6%) | 87 (92.6%) |  | 295 (93.1%) | 99 (94.3%) |  |
 Yes | 28 (6.6%) | 21 (6.4%) | 7 (7.4%) |  | 22 (6.9%) | 6 (5.7%) |  |
Jejunostomy | Â | Â | Â | 0.763 | Â | Â | 0.377 |
 No | 406 (96.2%) | 316 (96.3%) | 90 (95.7%) |  | 303 (95.6%) | 103 (98.1%) |  |
 Yes | 16 (3.8%) | 12 (3.7%) | 4 (4.3%) |  | 14 (4.4%) | 2 (1.9%) |  |
ICU admission | Â | Â | Â | 0.450 | Â | Â | 0.824 |
 No | 201 (47.6%) | 153 (46.6%) | 48 (51.1%) |  | 150 (47.3%) | 51 (48.6%) |  |
 Yes | 221 (52.4%) | 175 (53.4%) | 46 (48.9%) |  | 167 (52.7%) | 54 (51.4%) |  |
Mechanical ventilation, hour | 7.5 (5.6–14.9) | 7.5 (5.6–15.5) | 7.6 (5.9–14.4) | 0.913 | 7.5 (5.5–15.5) | 8 (5.8–14.5) | 0.607 |
CR-POPF | Â | Â | Â | 0.000 | Â | Â | 0.335 |
 No | 353 (83.6%) | 288 (87.8%) | 65 (69.1%) |  | 262 (82.6%) | 91 (86.7%) |  |
 Yes | 69 (16.4%) | 40 (12.2%) | 29 (30.9%) |  | 55 (17.4%) | 14 (13.3%) |  |
Intra-abdominal infection | Â | Â | Â | 0.000 | Â | Â | 0.460 |
 No | 391 (92.7%) | 318 (97.0%) | 73 (77.7%) |  | 292 (92.1%) | 99 (94.3%) |  |
 Yes | 31 (7.3%) | 10 (3.0%) | 21 (22.3%) |  | 25 (7.9%) | 6 (5.7%) |  |
Lung infection | Â | Â | Â | 0.050 | Â | Â | 1.000 |
 No | 407 (96.4%) | 320 (97.6%) | 87 (92.6%) |  | 306 (96.5%) | 101 (96.2%) |  |
 Yes | 15 (3.6%) | 8 (2.4%) | 7 (7.4%) |  | 11 (3.5%) | 4 (3.8%) |  |
Urinary infection | Â | Â | Â | 1.000 | Â | Â | 1.000 |
 No | 417 (98.8%) | 324 (98.8%) | 93 (98.9%) |  | 313 (98.7%) | 104 (99%) |  |
 Yes | 5 (1.2%) | 4 (1.2%) | 1 (1.1%) |  | 4 (1.3%) | 1 (1%) |  |
Intestinal flora disturbance | Â | Â | Â | 0.310 | Â | Â | 0.602 |
 No | 417 (98.8%) | 325 (99.1%) | 92 (97.9%) |  | 314 (99.1%) | 103 (98.1%) |  |
 Yes | 5 (1.2%) | 3 (0.9%) | 2 (2.1%) |  | 3 (0.9%) | 2 (1.9%) |  |
Incisional infection | Â | Â | Â | 0.000 | Â | Â | 1.000 |
 No | 411 (97.4%) | 326 (99.4%) | 85 (90.4%) |  | 309 (97.5%) | 102 (97.1%) |  |
 Yes | 11 (2.6%) | 2 (0.6%) | 9 (9.6%) |  | 8 (2.5%) | 3 (2.9%) |  |
CR-DGE | - | - | - | - | Â | Â | 0.815 |
 No |  |  |  |  | 248 (78.2%) | 81 (77.1%) |  |
 Yes |  |  |  |  | 69 (21.8%) | 24 (22.9%) |  |