For histological assessment, a cross-sectional sample of distal donor bile duct was taken at the end of cold ischemia just before liver implantation. Specimens were processed in 10% neutral buffered formalin and stained in hematoxylin and eosin. They were examined independently by 2 blinded hepatobiliary pathologists‚ and discrepancies in scores were resolved with multiheader consensus. Bile duct injury was scored using a bile duct injury scoring system as described by Op den Dries et al.4 (link) This is a semiquantitative systematic histological scoring system for bile duct injury that examines the biliary epithelium, mural stroma, vascular plexus, peribiliary glands, inflammation, bleeding‚ and thrombosis within bile duct samples. This histological scoring system has been shown to correlate with biliary complications.4 (link)Recipients were managed intraoperatively and postoperatively in the standard fashion at the ANLTU. Recipients were followed up for 24 mo‚ and medical records were comprehensively reviewed for outcome data. The clinical endpoint was biliary complications occurring within 24 mo from transplantation. Biliary complications were diagnosed by clinical or biochemical suspicion, and routine imaging was not performed because of low diagnostic yield in asymptomatic patients.15 (link) No threshold for liver biochemistry was used to trigger biliary investigation. Biliary complications included biliary strictures and bile leaks. Biliary strictures were defined as any narrowing of the donor biliary tree on magnetic resonance cholangiopancreatography or endoscopic retrograde cholangiopancreatography.16 (link),17 (link) Not all cases of biliary strictures underwent endoscopic retrograde cholangiopancreatography because of anatomic location or severity of clinical symptoms. Biliary strictures were subcategorized into anastomotic strictures (AS) and non-AS (NASs). AS was defined as strictures localized to the biliary anastomosis. NAS was defined as any stricture in the donor biliary tree away from the biliary anastomosis. Bile leak was defined as the presence of bilirubin in the posttransplant drain or extravasation of bile on biliary imaging.
This trial was prospectively registered on the Australian and New Zealand Clinical Trials Registry (U1111-1179-9801) and approved by the Sydney Local Health District Ethics Review Committee (Approval Number X15-0444).