Table 2.
Prospective clinical trials on normothermic ex vivo liver perfusion
| Publication | Perfusion device | Donors | RCT | N | Group | Donor age | Recipient age | Recipient MELD | Perfusion time (min) | Peak AST (POD 1–7) (U/l) | EAD (%) | ICU (d) | HLS (d) | 1-year patient survival (%) | 1-year graft survival (%) | Biliary complication |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ravikumar et al. (2016) | OrganOX | DBD/DCD | No | 20 | NMP | 58 (21–85) | 54.4 (33–66) | 12 (7–27) | 558 (210–1110) | 417 (84–4681) | 15 | 3 (1–8) | 12 (6–34) | 95 | n.a. | 3 |
| 40 | Control (SCS) | 58.5 (21–82) | 55.0 (27–65) | 14 (6–25) | - | 902 (218–8786) | 22.5 | 3 (1–41) | 14 (8–88) | n.a. | n.a. | n.a. | ||||
| Selzner et al. (2016) | OrganOX | DBD/DCD | No | 10 | NMP | 48 (17–75) | 56 (45–71) | 21 (8–40) | 480 (340–580) | 1182 (167–6700) | n.a. | 1 (0–8) | 11 (8–17) | n.a. | n.a. | 0 |
| 30 | Control (SCS) | 46 (22–68) | 54 (42–63) | 23 (7–37) | - | 1474 (521–5156) | n.a. | 2 (0–23) | 13 (7–89) | n.a. | n.a. | n.a. | ||||
| Bral et al. (2017) | OrganOX | DBD/DCD | No | 10 | NMP | 56 (14–71) | 53 (28–67) | 13 (9–32) | 690 (198–1350) | 1252 (383–2600) | 55.5 | 16 (2–65) | 45 (13–114) | n.a. | n.a. | 0 |
| 30 | Control (SCS) | 52 (20–77) | 59 (43–69) | 19 (7–34) | - | 839 (153–2600) | 29.6 | 4 (1–29) | 25 (9–89) | n.a. | n.a. | 4 | ||||
| Nasralla et al. (2018) | OrganOX | DBD/DCD | Yes | 121 | NMP | 56 (16–84) | 55 (20–72) | 13 (6–35) | 547.5 (85–1388) | 488.1 (409–583) | 10,1 | 4 (2–7) | 15 (10–24) | 95.8 (90–98) | 95.0 (89–98) | 13 |
| 101 | Control (SCS) | 56 (20–86) | 55 (22–70) | 14 (6–29) | - | 964.9 (795–1172) | 29,9 | 4 (3–7) | 15 (11–24) | 97 (91–99) | 96 (90–99) | 15 | ||||
| Liu et al. (2020) | Self-made | DBD/DCD | No | 21 | NMP/pSCS NMP | 35.0 (± 12.7) | 57.0 (± 7.1) | 19.1 (± 7.7) | 296 (201–472) | 1357 (± 1492) | 19 | 2.5 (± 2.8) | 13.4 (± 9.1) | 95.24 | 100 | n.a. |
| 84 | control (SCS) | 34.8 (± 15.0) | 57.4 (± 8.4) | 19.4 (± 8.7) | - | 2615 (± 2541) | 46 | 2.7 (± 3.7) | 15.7 (± 14.2) | n.a. | n.a. | n.a. | ||||
| Bral et al. (2019) | OrganOX | DBD/DCD | No | 17 | NMP | 40 (14–71) | 59 (50–63) | 25 (21–32) | 618 (198–1344) |
709 (283–1921) |
35 | 6 (3–48) | 43 (22–61) | n.a. | n.a. | 4 |
| 26 | pSCS NMP | 37 (15–67) | 57 (40–63) | 22 (17–24) | 468 (249–1008) | 863 (460–1640) | 19 | 2 (2–4) | 16 (12–20) | n.a. | n.a. | 4 | ||||
| Ceresa et al. (2019) | OrganOx | DBD/DCD | No | 31 | pSCS NMP | 58 (17–78) | 58 (25–73) | 14 (7–24) | 504 (± 244) | 457 (92–8669) | 13 | 3 (1–20) | 3 (7–31) | 90 | 84 | 2 |
| 104 | NMP | 55 (17–83) | 56 (20–73) | 13 (6–33) | n.a. | 465 (68–8822) | 11 | 4 (1–23) | 14 (10–24) | n.a. | 94 | n.a. | ||||
| Ghinolfi et al. (2019) | Liver Assist | DBD | Yes | 10 | pSCS NMP | 81 (77–87) | 57 (46–61) | 12.5 (9–16) | 250 (195–282) | 709 (371–1575) | 20 | n.a. | 17 (14–22) | n.a. | n.a. | 1 |
| 10 | SCS | 80 (72–87) | 55 (43–61) | 9.5 (8–15) | - | 574 (377–1162) | 10 | n.a. | 12 (11–15) | n.a. | n.a. | 0 | ||||
| Mergental et al. (2016) | Liver Assist/OrganOx | DBD/DCD | No | 5 | pSCS NMP | 49 (29–54) | 56 (47–66) | 8 (7–17) | 332 (318–564) | n.a. | 0 | 3 (2–6) |
10 (6–15) |
n.a. | n.a. | - |
| Watson et al. (2017) | Liver Assist | DBD/DCD | No | 12 | pSCS NMP | 56 (24–67) | 57 (46–65) | 17 (10–26) | 284 (122–530) | n.a. | n.a. | n.a. | n.a. | 92 | 83 | 3 |
| 24 | SCS | 54 (22–72) | n.a. | n.a. | – | n.a. | n.a. | n.a. | n.a. | 96 | 88 | 7 | ||||
| Mergental et al. (2020) | OrganOx | DBD/DCD | No | 22 | pSCS NMP | 56 (45–65) | 56 (46–65) | 12 (9–16) | 587 (450–705) | n.a. | 31.8 | 3.5 (3–4) | 10 (8–17) | 100 | 86.4 | 6 |
| 44 | SCS | n.a. | n.a. | n.a. | - | n.a. | 9.1 | 2.0 (1–5) | 9 (8–11) | 95.5 | 86,4 | 4 |