A prospective randomized trial was performed at the Australian National Liver Transplantation Unit (ANLTU) from March 2016 to June 2017. Written informed consent was obtained from each enrolled recipient, and the study was performed in accordance with the ethical guidelines of the 2000 Declaration of Helsinki. Brain dead donor livers procured and transplanted in adult recipients within New South Wales, Australia, were eligible. Donors were randomized just before organ procurement to either the control or intervention group using random number generation by the primary investigator who was not involved in donor recruitment (M.L.) (Figure 2). Allocation was disclosed to the donor surgical team but not to the liver transplant team or the recipient.
The control group received our standard protocol for biliary flushing with an antegrade cystic duct flush with normal saline via cholecystotomy during the warm phase of organ procurement followed by a single retrograde bile duct flush on the back table after donor hepatectomy with 75 mL of UW solution (Belzer UW, Bridge to Life) (Figure 1A).
The intervention group received the antegrade cystic duct flush via cholecystotomy followed by 2 retrograde bile duct flushes. The first (additional) bile duct flush was performed immediately after aortic cross clamp with 60 mL of cold Marshall solution (Soltran, Baxter, United Kingdom) using a silastic infant feeding catheter and 60-mL syringe via a distal choledochotomy. The additional bile duct flush was performed after aortic cross clamp because of the high potassium content of Marshall solution and to reduce bile salt injury during cold ischemia. Marshall solution was chosen as the low-viscosity bile duct flush because of availability at our center. Sixty milliliters was the largest volume in a single syringe and chosen as the flush volume. The second bile duct flush was performed as in the control group, after donor hepatectomy with 75 mL of cold UW solution (Figure 1B). The viscosity of UW is significantly higher than Marshall solution because of the addition of raffinose, glutathione, allopurinol, adenosine, pentafraction, and lactobinoic acid.12 (link) Otherwise, standard organ procurement techniques as previously described by the ANLTU were used in both groups.13 ,14 (link)