Removable Intraductal Stenting in Duct-to-duct Biliary Reconstruction in Liver Transplantation

Comparative, multicentric, prospective, randomized non-blinded, two-groups study. The follow-up is set at six months postoperative for a good screening of the majority of biliary complications. The inclusion period is set at 3.5 years, for total study duration of 4 years. The patients' inclusion will be made in 7 liver transplantation centers in France. Patients' inclusion will be performed in consultation at the moment of enlistment for LT, where they will be informed of the content, the benefits and risks of the study, and have to sign a written consent. Definitive inclusion will be performed in operating room, during LT, and depends on fulfilling of the following "definitive inclusion criteria" (see above). The randomization will be performed in operating room by the investigator and coordinated by the Clinical Research Unit of promoters' center (Saint Antoine Hospital, Paris), with a specific software accessible on the Internet. In the IST group, the surgeon will place the IST in the bile duct, which is a custom-made segment (2 cm) of a 8 French T-tube with no side holes. The stent is inserted in the biliary duct without suture fixation. In order to minimize bias and to homogenize the technique, a short technical explanatory movie will be realized by the promoter's team and distributed in each center. Each center will perform its habitual postoperative follow up. Clinical, biological, and radiological exhaustive data will be collected at Day 1, Day 7, Day 15, Month 1, Month 3, Month 6. A Magnetic Resonance Cholangiography (MRC) will be systematically performed at six months post LT. In the IST group, an endoscopic retrograde cholangio-pancreatography (ERCP) with sphincterotomy will be planned between the 4th and the 5th month post-transplantation, requiring a short stay in hospital, a general anesthesia, clinical and biological tests including plasmatic lipase dosage at Day 1. Every undesirable event will be immediately reported to the promoter for further investigation within its severity. Severe undesirable events will be previously defined.