The utility of bile duct stent placement in liver transplantation

Patients in the treatment arm will not receive a biliary stent (no-stent group). Patients in the control arm will receive a stent (stent group). No intervention is required in the treatment arm (no-stent group) as the biliary anastomosis is performed without a stent. Inclusion and Exclusion criteria Participants in the trial will be adult patients on the liver transplant waiting list who are planned to receive a whole liver allograft with a duct to duct biliary anastomosis from brain dead donors. Surgeons in the liver transplant team who have agreed to participate in this trial will have the allocation arm disclosed to them after complete graft reperfusion including completion of the arterial anastomosis. The allocation to stent or no-stent must be adhered to, to reduce selection bias. Contingency planning for a surgeon who is not comfortable with the allocation will be to have an alternative surgeon available to perform the anastomosis. Patients will be excluded from the project if they are planned to receive any graft other than a whole liver from a brain dead donor. Given the higher biliary complication rate in split liver and DCD grafts these have been excluded. Patients who have a biliary reconstruction involving a hepaticoenterostomy will also be excluded. On occasion it is necessary to defer biliary reconstruction because of bleeding or because of recipient haemodynamic instability. This event occurs uncommonly, but has the potential to skew results because biliary complications are likely to be higher, and allocation may be asymmetrical across arms. Approximate duration of surgery ranges from 4-12 hours. Randomisation technique Randomisation will be achieved by a computer-generated table using the online website (https://www.sealedenvelope.com). Allocation to study arms will be in a 1:1 ratio, in blocks of 20 to minimise asymmetrical allocation on completion of patient accrual. Each allocation (stent, or no stent) will be printed and placed in order (1-100) in an opaque sealed (with glue and staple) envelope by three investigators and stored within a secure combination-lock safe. Only the three investigators and the clinical nurse coordinator (CNC) for liver transplant in operating theatres will know the four-digit code to minimise any potential observer/investigator interference. One of these four persons will be available at the allocation time to access the the safe. The description of the biliary anastomosis including whether or not a stent was placed will be documented in the operation report.