NCT02356939: BILIDRAINT

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

Terminated NA Last updated 29 October 2021

What this trial tests

NA trial testing intraductal removable stent custom-made segment (2 cm) in Transplantation, Liver in 493 participants. Terminated before completion.

Timeline

3 April 2015

Primary endpoint
22 May 2019

22 May 2019

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	493
Start date	3 April 2015
Primary completion	22 May 2019
Estimated completion	22 May 2019
Sites	1 location across France

Drugs / interventions tested

• intraductal removable stent custom-made segment (2 cm)
• stent extraction by ERCP

Conditions studied

• Transplantation, Liver — all drugs for Transplantation, Liver →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Transplantation, Liver. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Randomized controlled trial including 7 French transplantation centers. Pre-inclusion of the patients is made when enlisted for liver transplantation (LT). Definitive inclusion and randomization is performed during LT, for patients undergoing a duct-to-duct biliary anastomosis with a graft bile duct diameter smaller than 7mm. In the intraductal stent tube group, a custom-made segment of a T-tube is placed into the bile duct, and removed endoscopically four to six months postoperative. The surgical technique is available on a movie during randomization on the website. The primary endpoint is the occurrence of biliary complications, including biliary fistulae and strictures, during six months of follow-up. Secondary evaluation criteria are the incidence of complications related to the stent placement and its extraction by endoscopy.

Discussion: Biliary complications following LT are significant causes of morbidity, retransplantation and eventually mortality. Although controversial, the use of a T-tube has been proven to be useless and even responsible for specific complications in many studies, including several randomized trials. However, several studies have identified a small bile duct diameter as a risk factor for biliary stenosis. A threshold of 7mm was found to be significantly associated to biliary stenosis. Our team published a preliminary study including 20 patients using a new technique of intraductal stenting. Only 4 complications were reported in the overall study population while no biliary complication occurred in the subgroup of patients who received a whole graft LT. Moreover, no technical failure and no procedure-related complications were noted before and during drain removal. Although intraductal stent tube in duct-to duct biliary anastomosis seems feasible and safe, a multicentric randomized controlled study is needed to validate it as a protective tool for biliary complications following LT.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Biliary reconstruction with or without an intraductal removable stent in liver transplantation: study protocol for a randomized controlled trial.
   Goumard C, Cachanado M, Herrero A, Rousseau G, et al · · 2015 · cited 12× · PMID 26719017 · DOI 10.1186/s13063-015-1139-6
2. Duct-to-duct biliary reconstruction with or without an intraductal removable stent in liver transplantation: The BILIDRAIN-T multicentric randomised trial.
   Goumard C, Boleslawski E, Brustia R, Dondero F, et al · · 2022 · cited 3× · PMID 36082313 · DOI 10.1016/j.jhepr.2022.100530