Table 2.
Minimally invasive vs open pancreaticoduodenectomy published randomized clinical trials
| Palanivelu 2017 (PLOT), Lps vs Open[50] | Poves 2018 (PADULAP), Lps vs Open[51] | Van Hilst 2019 (LEOPARD 2), Lps vs Open[52] | Wang 2021, Lps vs Open[53] | Klotz 2024 (EUROPA), Robotic vs Open[62] | Liu 2024, Robotic vs Open[63] | |||||||||||||
| Enrollment period | 2013-2015 | 2013-2017 | 2016-2017 | 2018-2019 | 2020-2022 | 2022 | ||||||||||||
| MI | O | p | MI | O | p | MI | O | p | MI | O | p | MI | O | p | MI | O | p | |
| n | 32 | 32 | 34 | 32 | 50 | 59 | 297 | 297 | 29 | 33 | 81 | 80 | ||||||
| OT (minute) | 359 | 320 | 0.041 | 486 | 365 | 0.001 | 410 | 274 | 0.001 | 325 | 300 | 0.001 | 431 | 367 | 0.021 | 245 | 298 | 0.001 |
| EBL (mL) | 250 | 401 | 0.001 | 300 | 450 | NS | 200 | 300 | 0.001 | 742 | 814 | NS | 75 | 150 | 0.001 | |||
| CR-POPF (%) | 6 | 12 | NS | 13 | 28 | NS | 28 | 24 | NS | 10 | 11 | NS | 38 | 21 | NS | 14 | 13 | NS |
| Bile leakage (%) | 9 | 6 | NS | 3 | 10 | NS | 12 | 10 | NS | 13 | 14 | NS | 17 | 9 | NS | 16 | 23 | NS |
| Gastro/duodenojejunal fistula (%) | 0 | 0 | NS | 4 | 0 | NS | ||||||||||||
| Chyle leak (%) | 4 | 14 | 0.09 | 7 | 3 | NS | ||||||||||||
| DGE (%) | 16 | 22 | NS | 9 | 24 | NS | 34 | 20 | NS | 30 | 32 | NS | 34 | 6 | 0.005 | 25 | 33 | NS |
| PPH (%) | 9 | 12 | NS | 9 | 21 | NS | 10 | 14 | NS | 13 | 11 | NS | 14 | 3 | NS | 14 | 19 | NS |
| SSI (%) | 12 | 25 | 0.015 | 4 | 14 | 0.09 | 10 | 10 | NS | 10 | 11 | NS | ||||||
| Reintervention (%) | 3 | 3 | NS | 3 | 17 | 0.06 | 12 | 6 | NS | 3 | 4 | NS | 14 | 15 | NS | 3 | 4 | NS |
| Severe morbidity (Clavien-Dindo ≥ 3) (%) | 9 | 12 | NS | 16 | 38 | 0.048 | 50 | 39 | NS | 29 | 23 | NS | 22 | 24 | NS | |||
| LOS, days | 7 | 13 | 0.001 | 13.5 | 17 | 0.024 | 11 | 10 | NS | 15 | 16 | 0.02 | 17 | 13 | NS | 11 | 13.5 | 0.029 |
| Readmission (%) | 6 | 9 | NS | 22 | 14 | NS | 16 | 20 | NS | 3 | 2 | NS | 17 | 16 | NS | 7 | 6 | NS |
| 90-day mortality (%) | 3 | 3 | NS | 0 | 2 | NS | 10 | 2 | NS | 2 | 2 | NS | 0 | 9 | 1 | 1 | NS | |
| R0 (%) | 97 | 94 | NS | 60 | 52 | NS | 82 | 76 | NS | 98 | 97 | NS | 80 | 100 | NS | 96 | 96 | NS |
| N harvested Lymph nodes (n) | 18 | 17 | NS | 15 | 21 | NS | 11 | 11 | NS | 12 | 13 | NS | 29 | 26 | NS | 13 | 13 | NS |
OT: Operative time; EBL: Estimated blood loss; CR-POPF: Clinically relevant-post-operative pancreatic fistula; DGE: Delayed gastric emptying; PPH: Post-pancreatectomy hemorrhage; SSI: Surgical site infection; LOS: Length of stay.