Table 2.
Histopathology outcomes in the (modified) intention-to-treat population.
| MIDP group (n = 114)a | ODP group (n = 110)a | Risk difference (%) (90% CI) | p-value | |
|---|---|---|---|---|
| Radicality of resectionb | ||||
| Radical, R0 resection—≥1 mm | 83 (72.8) | 76 (69.1) | 3.7 (−6.2 to 13.6) | 0.039 (Pnon-inferiority) |
| Non-radical resection—<1 mm | 31 (27.2) | 34 (30.9) | ||
| Lymph node yield | 22.0 (16.0–30.0) | 23.0 (14.0–32.0) | 0.86 | |
| Positive lymph nodes | 1.0 (0.0–3.0) | 1.0 (0.0–3.0) | 0.82 | |
| Histopathological tumor size—mm | 30.0 (23.0–42.0) | 29.0 (20.0–40.0) | 0.56 | |
| Poor tumor differentiation | 32 (31.7) | 38 (40.9) | 0.18 | |
| Perineural invasion | 90 (78.9) | 83 (75.5) | 0.53 | |
| Lymphovascular invasion | 77 (67.5) | 72 (65.5) | 0.74 | |
| T-stadium | 0.89 | |||
| T1 | 22 (19.3) | 26 (23.6) | ||
| T2 | 64 (56.1) | 59 (53.7) | ||
| T3 | 28 (24.6) | 25 (22.7) | ||
| T4 | 0 (0.0) | 0 (0.0) | ||
| N-stadium | 0.08 | |||
| N0 | 43 (37.7) | 47 (42.7) | ||
| N1 | 53 (46.5) | 36 (32.7) | ||
| N2 | 18 (15.8) | 27 (24.5) | ||
| M-stadium | NA | |||
| M0 | 114 (100.0) | 110 (100.0) | ||
| M1 | 0 (0.0) | 0 (0.0) | ||
| Histopathological diagnosis | 0.98 | |||
| Pancreatic cancer | 107 (93.9) | 101 (91.8) | ||
| NET | 3 (2.6) | 3 (2.7) | ||
| Other | 4 (3.5) | 6 (5.5) |
Categorical data are reported in numbers and frequencies.
Continuous data are reported in median (IQR).
MIDP, Minimally invasive distal pancreatectomy; ODP, Open distal pancreatectomy; IQR, Interquartile range; NET, Neuroendocrine tumor.
a
Analyses were performed according to modified intention-to-treat since histopathology data were not available for patients with unresectable disease (n = 27) and for 7 patients with missing data on primary endpoint (3 MIDP, 4 ODP) because of different diagnosis.
b
As measured at the transection and posterior margins.