TABLE 2.
Operative Outcomes and Pathologic Findings of the Intention-to-treat and Per-protocol Population
| Intention-to-treat analysis Conventional (n=181) | Mesenteric(n=179) | P | Per-protocol analysis Conventional (n=164) | Mesenteric (n=151) | P | |
|---|---|---|---|---|---|---|
| Operative time, (IQR) min | 379 (324–464) | 419 (353–507) | 0.002 | 380 (327–466) | 424 (359–515) | 0.001 |
| Intraoperative blood loss, mL | 430 (187–713) | 472 (268–883) | 0.033 | 454 (208–740) | 480 (292–891) | 0.071 |
| Postoperative complications*, ≥grade III, (%) | 13 (7) | 11 (6) | 0.833 | 13 (8) | 11 (7) | >0.999 |
| Pancreatic fistula, (%)† | 12 (7) | 11 (6) | >0.999 | 12 (7) | 9 (6) | 0.659 |
| Delayed gastric emptying, (%)† | 17 (9) | 12 (7) | 0.493 | 16 (10) | 11 (7) | 0.547 |
| Intra-abdominal hemorrhage, (%)† | 7 (4) | 4 (2) | 0.543 | 7 (4) | 3 (2) | 0.340 |
| Diarrhea‡, grade 3–4, (%) | 3 (2) | 9 (5) | 0.086 | 3 (2) | 9 (6) | 0.076 |
| Mortality, (%) | 1 (1) | 0 (0) | >0.999 | 1 (1) | 0 (0) | >0.999 |
| Pathologic findings | ||||||
| Marginal status, R0, (%) | 156 (86) | 151 (84) | 0.657 | 148 (90) | 136 (90) | >0.999 |
| Harvested lymph nodes, (%) | 26 (19–34) | 33 (23–40) | <0.001 | 27 (20–35) | 32 (24–40) | <0.001 |
| Lymph node metastasis, (%) | 96 (53) | 97 (54) | 0.833 | 96 (59) | 92 (61) | 0.730 |
| UICC-TNM stage, 8th edition | 0.902 | 0.935 | ||||
| 0/IA/IB, (%) | 1 (1)/36 (21)/25 (15) | 0 (0)/28 (17)/27 (16) | 1 (1)/35 (21)/25 (15) | 0 (0)/28 (19)/26 (17) | ||
| /IIA/IIB/III, (%) | /5 (3)/77 (45)/17 (10) | /4 (2)/75 (45)/21 (13) | /5 (3)/77 (47)/17 (10) | 3 (2)/71 (47)/19 (13) | ||
| /IV, (%) | /12 (7) | /13 (8) | /3 (2) | 4 (3) | ||
| Missing data | n=8 | n=11 | n=1 (complete response) | n=0 | ||
| Introduction of adjuvant therapy, (%) | 150 (83) | 147 (82) | 0.671 | 145 (88) | 132 (87) | 0.863 |
| Regimen of adjuvant therapy | 0.684 | 0.457 | ||||
| S-1, (%) | 126 (84) | 126 (86) | 121 (83) | 115 (87) | ||
| 5-FU HAI plus gemcitabine, (%) | 11 (7) | 7 (5) | 11 (8) | 7 (5) | ||
| Gemcitabine plus S-1, (%) | 5 (3) | 7 (5) | 5 (3) | 6 (5) | ||
| Gemcitabine plus nab-paclitaxel, (%) | 5 (3) | 6 (4) | 5 (3) | 4 (3) | ||
| Gemcitabine, (%) | 3 (2) | 1 (1) | 3 (2) | 0 (0) | ||
| Time to adjuvant therapy, day | 45 (34–57) | 44 (33–55) | 0.544 | 47 (36–57) | 43 (31–55) | 0.193 |
| Completion of adjuvant therapy, (%) | 101 (56) | 92 (51) | 0.387 | 96 (59) | 83 (55) | 0.524 |
| Postoperative recurrence, (%) | 110 (61) | 99 (55) | 0.293 | 106 (65) | 94 (62) | 0.661 |
| Pattern of postoperative recurrence | 0.753 | 0.953 | ||||
| Local/remnant pancreas only, (%) | 32 (18) | 29 (16) | 32 (20) | 29 (19) | ||
| Systemic only, (%) | 65 (36) | 57 (32) | 61 (37) | 52 (34) | ||
| Local and systemic, (%) | 13 (7) | 13 (7) | 13 (8) | 13 (9) | ||
| Sites of postoperative recurrence | ||||||
| Local recurrence, (%) | 40 (22) | 38 (21) | 0.841 | 40 (24) | 38 (25) | 0.873 |
| Liver, (%) | 38 (21) | 30 (17) | 0.305 | 36 (22) | 27 (18) | 0.367 |
| Lung, (%) | 20 (11) | 18 (10) | 0.759 | 20 (12) | 17 (11) | 0.796 |
| Peritoneum, (%) | 17 (9) | 17 (10) | 0.973 | 15 (9) | 16 (11) | 0.666 |
| Distant lymph node, (%) | 12 (7) | 12 (7) | 0.978 | 12 (7) | 12 (8) | 0.833 |
| Remnant pancreas, (%) | 5 (3) | 4 (2) | >0.999 | 5 (3) | 4 (3) | >0.999 |
| Bone, (%) | 5 (3) | 1 (1) | 0.215 | 5 (3) | 1 (1) | 0.217 |
Data are the median [interquartile range (IQR)] or n (%).
*
Postoperative complications were graded by Clavien-Dindo classification.
†
Pancreatic fistula, delayed gastric emptying, and intra-abdominal hemorrhage were defined and graded according to the International Study Group of Pancreatic Surgery.
‡
Postoperative diarrhea was graded by Common Terminology Criteria for Adverse Events version 4.
AT indicates adjuvant therapy; HAI, hepatic arterial infusion; TNM, tumor-node-metastasis; UICC, International Union for Cancer Control.