Duct-to-duct biliary reconstruction with or without an intraductal removable stent in liver transplantation: The BILIDRAIN-T multicentric randomised trial.
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
Journal
JHEP reports : innovation in hepatology
ISSN: 2589-5559
Titre abrégé: JHEP Rep
Pays: Netherlands
ID NLM: 101761237
Informations de publication
Date de publication:
Oct 2022
Oct 2022
Historique:
received:
01
03
2022
revised:
26
05
2022
accepted:
15
06
2022
entrez:
9
9
2022
pubmed:
10
9
2022
medline:
10
9
2022
Statut:
epublish
Résumé
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. 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. 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 IRS does not prevent BC after LT and may require specific endoscopic expertise for removal. NCT02356939 (https://clinicaltrials.gov/ct2/show/NCT02356939?term=NCT02356939&draw=2&rank=1). 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.
Sections du résumé
Background & Aims
UNASSIGNED
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
UNASSIGNED
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
UNASSIGNED
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
Conclusions
UNASSIGNED
IRS does not prevent BC after LT and may require specific endoscopic expertise for removal.
Trial registration number ClinicalTrialsgov
UNASSIGNED
NCT02356939 (https://clinicaltrials.gov/ct2/show/NCT02356939?term=NCT02356939&draw=2&rank=1).
Lay summary
UNASSIGNED
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.
Identifiants
pubmed: 36082313
doi: 10.1016/j.jhepr.2022.100530
pii: S2589-5559(22)00102-1
pmc: PMC9445377
doi:
Banques de données
ClinicalTrials.gov
['NCT02356939']
Types de publication
Journal Article
Langues
eng
Pagination
100530Informations de copyright
© 2022 The Authors.
Déclaration de conflit d'intérêts
The authors have declared no conflicts of interest in relation to this study. Please refer to the accompanying ICMJE disclosure forms for further details.
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