Duct-to-duct biliary reconstruction with or without an intraductal removable stent in liver transplantation: The BILIDRAIN-T multicentric randomised trial

Claire Goumard, Emmanuel Boleslawski, Rafaelle Brustia, Federica Dondero, Astrid Herrero, Mickael Lesurtel, Louise Barbier, Katia Lecolle, Olivier Soubrane, Hassan Bouyabrine, Jean Yves Mabrut, Ephrem Salamé, Marine Cachanado, Tabassome Simon, Olivier Scatton, Claire Goumard, Emmanuel Boleslawski, Rafaelle Brustia, Federica Dondero, Astrid Herrero, Mickael Lesurtel, Louise Barbier, Katia Lecolle, Olivier Soubrane, Hassan Bouyabrine, Jean Yves Mabrut, Ephrem Salamé, Marine Cachanado, Tabassome Simon, Olivier Scatton

Abstract

Background & aims: Biliary complications (BC) following liver transplantation (LT) are responsible for significant morbidity. No technical procedure during reconstruction has been associated with a risk reduction of BC. The placement of an intraductal removable stent (IRS) during reconstruction followed by its endoscopic removal showed feasibility and safety in a preliminary study. This multicentric randomised controlled trial aimed at evaluating the impact of an IRS on BC following LT.

Methods: This multicentric randomised controlled trial was conducted in 7 centres from April 2015 to February 2019. Randomisation was done during LT when a duct-to-duct anastomosis was confirmed with at least 1 of the stump diameters ≤7 mm. In the IRS group, a custom-made segment of a T-tube was placed into the bile duct to act as a stake during healing and was removed endoscopically 4 to 6 months post LT. The primary endpoint was the incidence of BC (fistulae and strictures) within 6 months post LT. The secondary criteria were complications related to the IRS placement or extraction, including endoscopic retrograde cholangio-pancreatography (ERCP)-related complications.

Results: In total, 235 patients were randomised: 117 in the IRS group and 118 in the control group. BC occurred in 31 patients (26.5%) in the IRS group vs. 24 (20.3%) in the control group (p = 0.27), including 16 (13.8%) and 15 (12.8%) strictures, respectively. IRS migration occurred in 24 patients (20.5%), cholangitis in 1 (0.9%), acute pancreatitis in 2 (1.8%), and difficulty during endoscopic extraction in 19 (19.4%). No predictive factor for BC was identified.

Conclusions: IRS does not prevent BC after LT and may require specific endoscopic expertise for removal.

Trial registration number clinicaltrialsgov: NCT02356939 (https://ichgcp.net/clinical-trials-registry/NCT02356939?term=NCT02356939&draw=2&rank=1).

Lay summary: Liver transplantation is a life-saving treatment for many patients with end-stage liver disease. However, it can be associated with complications involving the bile duct reconstruction. Herein, the placement of a specific stent called an intraductal removable stent was trialled as a way of reducing bile duct complications in patients undergoing liver transplantation. Unfortunately, it did not help preventing such complications.

Keywords: ABC, arterial and biliary complications; BC, biliary complications; Biliary complications; Biliary reconstruction; CMV, cytomegalovirus; DMC, data monitoring committee; ERCP, endoscopic retrograde cholangio-pancreatography; HCC, hepatocellular carcinoma; HR, hazard ratio; IRS, intraductal removable stent; Intraductal stent; LT, liver transplantation; Liver transplantation; MRC, magnetic resonance cholangiography; OR, odds ratio; Removable stent.

Conflict of interest statement

The authors have declared no conflicts of interest in relation to this study. Please refer to the accompanying ICMJE disclosure forms for further details.

© 2022 The Authors.

Figures

Graphical abstract
Graphical abstract
Fig. 1
Fig. 1
IRS placement across biliary anastomosis. The stent is a custom-made segment (2 cm) of an 8-French T-tube inserted in the biliary duct across the anastomosis without suture fixation. The lower end is sitting on the papilla without crossing it. Courtesy of Dr. R. Brustia. IRS, intraductal removable stent.
Fig. 2
Fig. 2
CONSORT diagram of enrolment and follow-up.
Fig. 3
Fig. 3
Overall, graft and ABC-free survival in patients in the IRS vs. control groups. (A) Overall survival at 6 months post LT in the IRS and control groups. (B) Graft survival at 6 months post LT in the IRS and control groups. (C) ABC-free survival at 6 months post LT in the IRS and control groups. ABC, arterial and biliary complications; IRS, intraductal removable stent; LT, liver transplantation.

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