Study protocol for a multicenter randomized controlled trial to compare the efficacy of end-ischemic dual hypothermic oxygenated machine perfusion with static cold storage in preventing non-anastomotic biliary strictures after transplantation of liver grafts donated after circulatory death: DHOPE-DC
van Rijn, R., van den Berg, A. P. et al. (2019).BMC Gastroenterology 19(1): 40.
Aims
To determine the efficacy of end-ischaemic dual hypothermic oxygenated machine perfusion (DHOPE) in reducing the incidence of non-anastomotic biliary strictures (NAS) after donation after circulatory death (DCD) liver transplantation.
Interventions
Liver grafts will either be preserved with static cold storage (SCS) followed by 2 hours of DHOPE (intervention group) or SCS alone without any further intervention (control group).
Participants
156 patients undergoing DCD liver transplantation (>18 years).
Outcomes
Primary outcome will be measured as symptomatic NAS. Secondary outcomes will be measured as incidence of asymptomatic NAS, severity of NAS, graft and recipient survival, liver failure requiring retransplantation or leading to death, initial poor function based on a modification of the Olthoff criteria, graft function and ischaemia-reperfusion injury measured by alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (AlkP), gamma-glutamyl transferase (γGT), and total bilirubin at postoperative day 0–7 and 1, 3, and 6months, ICU and hospital stay following live
Follow-up
6 months.
CET Conclusions
This is the study protocol for the DHOPE-DCD trial, a multicentre, inferiority, randomized controlled trial which will compare cold storage plus two hours of dual, end-ischemic hypothermic oxygenated machine perfusion versus cold storage alone in donation after circulatory death liver transplantation. The power calculation is based the primary outcome non-anastomotic biliary strictures (NAS) at 6 months and showed that 154 are needed plus 1 patient in each arm to allow for dropouts for 80% power. The procurement surgeon and the patients will be blinded to group assignment and the primary outcome NAS will be assessed by a blinded adjudication committee. Randomisation will be done using a web-based tool and patients will not be randomised until a liver is deemed suitable for transplantation. Data will be analysed according to the intention to treat principle.
Trial registration
ClinialTrials.gov - NCT02584283