A Multicenter Randomized Controlled Trial to Compare the Efficacy of End-ischemic Dual Hypothermic Oxygenated Perfusion with Standard Static Cold Storage of Liver Grafts Donated after Circulatory Death in Preventing Non-anastomotic Biliary Strictures after Transplantation

A Multicenter Randomized Controlled Trial to Compare the Efficacy of End-ischemic Dual Hypothermic Oxygenated Perfusion with Standard Static Cold Storage of Liver Grafts Donated after Circulatory Death in Preventing Non-anastomotic Biliary Strictures after Transplantation - DHOPE-DCD Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47263

Enrollment

100

Registered

2018-11-01

Start date

2016-01-07

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-stage liver disease

Interventions

In the intervention group liver grafts will be subjected to two hours of hypothermic, oxygenated perfusion at the end of SCS and before implantation. In the control group donor liver grafts will be

donation after circulatory death

hypothermic oxygenated perfusion

liver transplantation

non-anastomotic biliary strictures

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Adult patients (>= 18 years old) with end-stage liver disease - Signed informed consent - Willing and able to attend follow-up examinations - Donor liver graft from a controlled donation after circulatory death (Maastricht category III) - Donors with a body weight >=40 kg

Exclusion criteria

Exclusion criteria: - Simultaneous participation in another clinical trial that might possibly influence this trial - Mental conditions rendering the subject incapable to understand the nature, scope and consequences of the trial - Listed for liver transplantation due to fulminant liver failure or retransplantation because of PNF - Recipient positive test for HIV - Donor positive for HIV, Hepatitis B or C - Patients with contra-indications for MRCP (i.e. pacemaker) - Patients with simultaneous transplantation of another organ

Design outcomes

Primary

Measure	Time frame
The incidence and severity of NAS as diagnosed by an Adjudication committee (who are blinded for the group assignment) by means of magnetic resonance cholangiopancreatography (MRCP) at six months after DCD liver transplantation.	—

Secondary

Measure	Time frame
To study the effect of the intervention (end-ischemic DHOPE after SCS), in comparison to the control group (SCS only), concerning: 1. The severity and time interval of NAS after transplantation 2. The graft and recipient survival 3. The incidence of primary non-function (PNF) 4. The incidence of initial poor function (IPF) 5. The biochemical analysis of graft function and ischemia-reperfusion injury 6. The hemodynamic status of the recipient after graft reperfusion 7. Length of stay in the ICU and hospital 8. The incidence of postoperative complications, including infections and use of antibiotics 9. The renal function 10. The perfusion characteristics during DHOPE (in the intervention group only) 11. The perfusate analysis during DHOPE (in the intervention group only) 12. Prognostication of NAS, based on micro ribonucleic acid (miRNA) profiles (in the intervention group only) 13. Pathobiology of liver parenchyma and bile duct samples 14. Metabolic function, including new onset diabetes after transplantation (NODAT) 15. Overall cost of treatment within 6 months (in/excluding return to work) 16. Health related quality of life	—

Measure

Time frame

To study the effect of the intervention (end-ischemic DHOPE after SCS), in comparison to the control group (SCS only), concerning: 1. The severity and time interval of NAS after transplantation 2. The graft and recipient survival 3. The incidence of primary non-function (PNF) 4. The incidence of initial poor function (IPF) 5. The biochemical analysis of graft function and ischemia-reperfusion injury 6. The hemodynamic status of the recipient after graft reperfusion 7. Length of stay in the ICU and hospital 8. The incidence of postoperative complications, including infections and use of antibiotics 9. The renal function 10. The perfusion characteristics during DHOPE (in the intervention group only) 11. The perfusate analysis during DHOPE (in the intervention group only) 12. Prognostication of NAS, based on micro ribonucleic acid (miRNA) profiles (in the intervention group only) 13. Pathobiology of liver parenchyma and bile duct samples 14. Metabolic function, including new onset diabetes after transplantation (NODAT) 15. Overall cost of treatment within 6 months (in/excluding return to work) 16. Health related quality of life

—

Countries

Belgium, Netherlands, United Kingdom

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)