None listed
Conditions
Brief summary
Biliary complications are significant cause of graft failure and morbidity in Liver Transplantation. Cellular injury has been shown in the literature to contribute to the development of biliary complications. A growing body of evidence demonstrate that bile duct injury occurs early after organ retrieval. Bile salt toxicity is a vector of injury to bile ducts which may be preventable. Experimental animal studies on pigs have indicated that flush the bile duct with hydrophobic bile salts and preservation solution can induce injury to the biliary epithelium during cold ischaemia. In addition, there have been studies demonstrating the importance of adequate biliary flush out before cold storage in liver transplantation, however this would typically occur at the backtable procedure in the donor surgery, which may be up to 20minutes from cross clamping. Our hypothesis is that an intraoperative bile duct flush (IBF) before cross clamping, will decrease exposure of hydrophobic bile salts to bile duct and reduce bile salt toxicity. The reduced bile salt toxicity should decrease injury to the bile duct which has been associated with the development of biliary strictures and biliary complications and highlights the expected benefit of the intervention.
Interventions
Intervention: Intraoperative Bile Duct Flush (Double Flush Group)
Standard Australian National Liver Transplant Unit (ANLTU) Protocol will be followed. The bile duct is partially transected and prolene stitch is placed on the distal end to mark the duct and facilitate manoeuvres. The intervention will then take place.
Before application of the aortic cross clamp, 8g silastic feeding tube will be inserted retrograde into the distal Bile Duct via the partial transection made during the Gallbladde
Intervention: Intraoperative Bile Duct Flush (Double Flush Group) Standard Australian National Liver Transplant Unit (ANLTU) Protocol will be followed. The bile duct is partially transected and prolene stitch is placed on the distal end to mark the duct and facilitate manoeuvres. The intervention will then take place. Before application of the aortic cross clamp, 8g silastic feeding tube will be inserted retrograde into the distal Bile Duct via the partial transection made during the Gallbladder flush. The 8g feeding tube is inserted at least 6cm into the bile duct and should reach the second order biliary branch. The 8g feeding tube is secured using the two threads of the tie used to secure the distal bile duct. The 8g feeding tube will then be connected to a 50mL syringe filled with 60mL of modified Ross/Marshall’s Solution (Soltran) (Maximum capacity of 50mL syringe). The Bile Duct will be flushed with the syringe within 5 minutes of aortic cross clamp application and start of cold perfusion. The flush will be performed by the leading surgeon. When the Bile Duct is flushed, the flush must be over a period of at least 1 minute with care taken not to induce high intraluminal pressures. The bile duct should not be clamped, and excess fluid should be free to flow from the point of insertion of the feeding tube. Following the flush, ANLTU standard protocol (Control/Single Flush Procedure) will take place and a second flush will occur at the backtable procedure of the donor surgery as follows; After Liver Explantation and during the backtable procedure of the donor surgery, a 8g silastic feeding tube is inserted into the distal Bile Duct up to the second order biliary branch. Using a 25mL syringe, the Bile Duct is flushed slowly with 75mL of U.W. (Viaspan). The bile duct should not be clamped, and excess fluid should be free to flow from the point of insertion of the feeding tube. This is to prevent high pressures damaging the Bile Duct. Before the procedure, a checklist and form will be supplied to the perfusionist to ensure protocol adherence and to obtain further information for analysis
Sponsors
Royal Prince Alfred Transplant Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All liver donors retrieved with the intent to be transplanted at the ANLTU will be included in the study
Exclusion criteria
Organ donors who are not eligible for Liver donation
Outcome results
None listed