T-tube or no T-tube in cadaveric orthotopic liver transplantation: the eternal dilemma: results of a prospective and randomized clinical trial.
Lopez-Andujar R, Montalva Oron E, et al.Annals of Surgery 2013; 258(1):21-9.
Aims
To compare the incidence and severity of biliary complications after choledochocholedochostomy (CCS) with or without a T-tube, in orthotopic liver transplant recipients.
Interventions
Patients received CCS with or with out a T-tube. In the non-T-tube group CCS was performed by an end-to-end anastomosis. The posterior face was made with a 6/0 polydiaxanone running suture and the anterior face was performed with 6/0 polydiaxanone interrupted sutures. In the T-tube group CCS was performed in the same way, however once the posterior face was completed a T-tube was placed into the biliary duct.
Participants
187 deceased full sized liver graft recipients <18 years old.
Outcomes
Primary outcomes were specified as the most severe complication for each patient including bile duct anastomosis leaks and stenosis.
Follow-up
6-35 months.
CET Conclusions
This trial attempts to shed more light on the on-going debate as to whether a T-tube should be used to protect the biliary anastomosis following OLT. Whilst it shows an overall similar biliary complication rate with or without a T-tube, the severity of complications and incidence of biliary stricture was lower with a T-tube. It is worth noting that there was a relatively high rate of T-tube attributable complications (23.2%), although most of these were biliary leaks following removal of the T-tube that occurred before the centre switched from latex to rubber T-tubes. The use of a per-protocol analysis led to the reduction of patient numbers in the final analysis below that required by the power calculation.
Data analysis
Per protocol analysis
Trial registration
ClinicalTrials.gov – NCT01546064