Table 1. Patient Characteristics and Pathologic Outcomesa.
| Variable | Intention-to-Treat Population | Per-Protocol Population | |||
|---|---|---|---|---|---|
| LDG (n = 673) | ODG (n = 686) | LDG (n = 644) | ODG (n = 611) | ||
| Age, mean (SD), y | 56.9 (10.9) | 57.5 (11.3) | 56.8 (10.8) | 57.8 (11.2) | |
| Sex | |||||
| Male | 448 (66.6) | 458 (66.8) | 426 (66.1) | 412 (67.4) | |
| Female | 225 (33.4) | 228 (33.2) | 218 (33.9) | 199 (32.6) | |
| BMI | 23.8 (2.9) | 23.8 (3.0) | 23.8 (2.9) | 23.8 (3.0) | |
| Clinical TNM stageb | |||||
| cT1N0M0 | 530 (78.8) | 531 (77.4) | 511 (79.3) | 465 (76.1) | |
| cT1N1M0 | 15 (2.2) | 19 (2.8) | 14 (2.2) | 19 (3.1) | |
| cT2N0M0 | 128 (19.0) | 136 (19.8) | 119 (18.5) | 127 (20.8) | |
| Extent of resectionc | |||||
| Distal gastrectomy | 664 (98.7) | 673 (98.1) | 644 (100) | 611 (100) | |
| Total gastrectomy | 8 (1.2) | 13 (1.9) | 0 | 0 | |
| Extent of lymphadenectomyc | |||||
| D1+ | 293 (43.5) | 245 (35.7) | 282 (43.8) | 215 (35.2) | |
| D2 | 379 (56.3) | 441 (64.3) | 362 (56.2) | 396 (64.8) | |
| No. of retrieved lymph nodes, mean (SD) | 40.5 (15.4) | 43.2 (15.9) | 40.5 (15.5) | 43.6 (15.8) | |
| ≤15 | 13 (1.9) | 10 (1.5) | 10 (1.6) | 8 (1.3) | |
| ≥16 | 660 (98.1) | 676 (98.5) | 634 (98.4) | 603 (98.7) | |
| Tumor size, mm | 26.7 (17.8) | 27.4 (17.1) | 25.8 (15.1) | 27.0 (16.4) | |
| Pathologic T classificationc | |||||
| T1 | 548 (81.4) | 549 (80.0) | 531 (82.5) | 485 (79.4) | |
| ≥T2 | 124 (18.4) | 137 (20.0) | 113 (17.5) | 126 (20.6) | |
| Pathologic N classificationc | |||||
| N0 | 571 (84.8) | 571 (83.2) | 553 (85.9) | 508 (83.1) | |
| N+ | 101 (15.0) | 115 (16.8) | 91 (14.1) | 103 (16.9) | |
| Pathologic stage | |||||
| I | 583 (86.6) | 579 (84.4) | 567 (88.0) | 516 (84.5) | |
| II | 60 (8.9) | 75 (10.9) | 52 (8.1) | 66 (10.8) | |
| III | 29 (4.3) | 32 (4.7) | 25 (3.9) | 29 (4.7) | |
| IV | 1 (0.1) | 0 | 0 | 0 | |
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); LDG, laparoscopic distal gastrectomy, ODG, open distal gastrectomy.
a
Data are presented as number (percentage) of patients unless otherwise indicated.
b
The TNM stage was determined according to the seventh edition of the American Joint Committee on Cancer/Union for International Cancer Control Cancer Staging Manual.
c
One patient who did not undergo gastrectomy because of carcinomatosis was excluded from the LDG group.