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

NCT02356939 | Terminated DMC

• 1 other identifier: P 130919
• Study Type: interventional
• Target: 493
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Transplantation, Liver

Outcome Measures

Primary Outcomes (1)

• Incidence of biliary strictures and biliary fistulae within six months post-transplantation.

  A biliary leakage is defined by the presence of bile in the abdominal drainage, and/or an intra-abdominal collection with bilious content requiring drainage. A biliary stenosis is defined by a size discrepancy between the two sides of the bile duct anastomosis on specific imaging (MR cholangiography, ERCP), associated to an upstream bile tract distention, with a clinical and biological cholestasis, after excluding other cholestasis causes (rejection, viral reactivation).

  6 months

Secondary Outcomes (3)

• Incidence of specific complications related to the IST and its extraction by endoscopy

  6 months

• Graft survival

  6 months

• Patient survival

  6 months

Study Arms (2)

Intraductal stent (IST)

EXPERIMENTAL

For intervention : intraductal removable stent 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. The stent is inserted in the biliary duct without suture fixation. In the IST group, an endoscopic retrograde cholangio-pancreatography (ERCP) with sphincterotomy will be planned between the 4th and the 6th month post-transplantation.

Device: intraductal removable stent custom-made segment (2 cm)

Without intraductal stent (no IST)

EXPERIMENTAL

For intervention : stent extraction by endoscopic retrograde cholangio-pancreatography (ERCP) Each center will perform its habitual postoperative follow up.

Procedure: stent extraction by ERCP

Interventions

intraductal removable stent custom-made segment (2 cm) DEVICE

: 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. 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 was realized by the promoter's team and edited on internet. 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.

Intraductal stent (IST)

stent extraction by ERCP PROCEDURE

stent extraction by endoscopic retrograde cholangio-pancreatography

Without intraductal stent (no IST)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients eligible for a liver transplantation
• Patients' written informed consent signed
• Patient with social coverage (excepting AME)

You may not qualify if:

• Biliary reconstruction decided to be a hepaticojejunostomy for anatomical/biliary disease reason
• Non eligibility for liver transplantation:
• \- Uncontrolled infectious process
• \- Incompatible physical or mental state with the observance of the immunosuppressive drugs
• \- Cardiopulmonary comorbidities severe / uncontrolled
• \- Active alcohol intoxication or addiction
• \- Pregnant or breastfeeding women (pregnancy test will be performed at baseline)
• Latex Allergy, polymer or rubber
• Patient participating in another interventional study about biliary disease

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Pitié Salpétrière

Paris, France

Location

Related Publications (30)

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Study Officials

• Olivier SCATTON, PU-PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Olivier SOUBRANE, PU-PH

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

• Claire GOUMARD, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2015
• First Posted: February 6, 2015
• Study Start: April 3, 2015
• Primary Completion: May 22, 2019
• Study Completion: May 22, 2019
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

FR (1)