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
Affiliations
Claire Goumard
Department of Digestive, Hepatobiliary Surgery and Liver Transplantation, Sorbonne Université, UMRS-938, Hôpital Pitié-Salpêtrière, Assistance Publique – Hôpitaux de Paris, Paris, France
Emmanuel Boleslawski
Department of Digestive, Hepatobiliary Surgery and Liver Transplantation, CHU Lille, Hôpital Huriez, Lille, France
Rafaelle Brustia
Department of Digestive and Hepato-pancreatic-biliary Surgery, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri Mondor, F-94010, Créteil, France
Federica Dondero
Department of Hepato-bilio-pancreatic Surgery and Liver Transplantation, Beaujon Hospital, Clichy, France
Astrid Herrero
Department of Digestive, Hepatobiliary Surgery and Liver Transplantation, CHR, Montpellier, France
Mickael Lesurtel
Hepatobiliary Surgery and Liver Transplantation, Service de Chirurgie Digestive et de Transplantation Hépatique, Hospices Civils de Lyon, Lyon, France
Louise Barbier
Department of Digestive, Hepato-biliopancreatic Surgery and Liver Transplantation, Hôpital Trousseau, CHRU Tours, Tours, France
Katia Lecolle
Department of Digestive, Hepatobiliary Surgery and Liver Transplantation, CHU Lille, Hôpital Huriez, Lille, France
Olivier Soubrane
Department of Hepato-bilio-pancreatic Surgery and Liver Transplantation, Beaujon Hospital, Clichy, France
Hassan Bouyabrine
Department of Digestive, Hepatobiliary Surgery and Liver Transplantation, CHR, Montpellier, France
Jean Yves Mabrut
Hepatobiliary Surgery and Liver Transplantation, Service de Chirurgie Digestive et de Transplantation Hépatique, Hospices Civils de Lyon, Lyon, France
Ephrem Salamé
Department of Digestive, Hepato-biliopancreatic Surgery and Liver Transplantation, Hôpital Trousseau, CHRU Tours, Tours, France
Marine Cachanado
Sorbonne Université, AP-HP, Department of Clinical Pharmacology and Unité de Recherche Clinique de l’Est Parisien (URCEST), Paris, France
Tabassome Simon
Sorbonne Université, AP-HP, Department of Clinical Pharmacology and Unité de Recherche Clinique de l’Est Parisien (URCEST), Paris, France
Olivier Scatton
Department of Digestive, Hepatobiliary Surgery and Liver Transplantation, Sorbonne Université, UMRS-938, Hôpital Pitié-Salpêtrière, Assistance Publique – Hôpitaux de Paris, Paris, France; Corresponding author Address: Department of Digestive, Hepatobiliary Surgery and Liver Transplantation, Sorbonne Université, UMRS-938, Hôpital Pitié-Salpêtrière, Assistance Publique – Hôpitaux de Paris, Paris, France. Tel.: +33 142175690; fax: +33 142175689.
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 (ClinicalTrials.gov): NCT02356939 (https://clinicaltrials.gov/ct2/show/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.