Clinical Trial: Evaluation of Liver Grafts With FibroScan® Before Organ Retrieval in Patients With Brain Death

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Evaluation of Liver Grafts With FibroScan® Before Organ Retrieval in Patients With Brain Death

Brief Summary:

According to the French Biomedicine Agency annual report on retrieval activities and transplants, 1,164 liver transplants were performed in 2011 and 1,161 in 2012. If the amount of brain death donors and retrieved liver grafts appears relatively stable, it remains clearly insufficient compared to the increasing number of patients on the waiting list for liver transplantation (2,462 in 2011). The median time on the waiting list before liver transplantation which was established from the cohort of patients registered between 2007 and 2011 (excluding patients registered for emergency transplantation and for living related-donor transplantation) increased significantly from 4.4 months between 2007 and 2009 to 6.6 months between 2010 and 2011. In order to compensate for the lack of liver grafts, donors acceptance criteria were broadened. For example, alternative transplantation lists were created with liver grafts coming from so-called "marginal" donors. However, despite these efforts, livers were retrieved on only two out of three brain death donors, i.e. in 1,572 and 1,589 organ donors in 2011 and 2012, respectively. This is unfortunately not enough to meet the increasing needs in liver grafts and a growing number of patients wait each year for transplant. Strategic lines of improvement were defined in order to meet the "2012-2016 transplant perspective" which targets 5,700 transplants carried out in 2015 (+5% every year, all transplants included, with 5,023 transplants in 2012).

According to the last consensus conference on liver transplantation of the HAS (French High Authority of Health) the assessment of the degree of macrovacuolar and microvacuolar steatosis determines the possibility to retrieve the graft or not. Liver steatosis consists in an accumulation of fatty droplets in hepatocytes. Its prevalence is high, ranging from 16% to 31% in the gener

Detailed Summary: Medical procedure: Fibroscan® based on vibration control transient elastography (VCTETM) with evaluation of controlled attenuation parameter (CAP™) by ultrasounds (Echosens, Paris, France).
Sponsor: University Hospital, Limoges

Current Primary Outcome: Controlled Attenuation Parameter™ (CAP™) measurement [ Time Frame: 1 Day ]

Evaluation of the diagnostic accuracy of the CAP™ measured with Fibroscan® to objectively reflect the degree of liver steatosis, a parameter which can be used as an aid in selecting liver grafts before retrieval in donors with brain death (DBD).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Liver Stiffness (LS) measurement [ Time Frame: 1 Day ]
    Evaluation of the diagnostic accuracy of LS measured with Fibroscan® to objectively reflect the degree of fibrosis and steatosis, a parameter which can be used as an aid in selecting liver grafts before retrieval in DBD
  • Controlled Attenuation Parameter™ (CAP™) measurement [ Time Frame: 1 week ]
    Determination of the prognostic value of CAP™ in terms of survival of liver grafts at one week after transplantation
  • Liver Stiffness (LS) measurement [ Time Frame: 1 week ]
    Determination of the prognostic value of LS in terms of survival of liver grafts at one week after transplantation
  • Liver Stiffness (LS) measurement [ Time Frame: 1 month ]
    Determination of the prognostic value of LS in terms of survival of liver grafts at one month after transplantation
  • Controlled Attenuation Parameter™ (CAP™) measurement [ Time Frame: 1 month ]
    Determination of the prognostic value of CAP™ in terms of survival of liver grafts at one month after transplantation
  • Liver Stiffness (LS) measurement [ Time Frame: 1 year ]
    Determination of the prognostic value of LS in terms of survival of liver grafts at one week, one month and one year after transplantation
  • Controlled Attenuation Parameter™ (CAP™) measurement [ Time Frame: 1 year ]
    Determination of the prognostic value of CAP™ in terms of survival of liver grafts at one week, one month and one year after transplantation
  • Fibrosis measurement [ Time Frame: 1 Day ]
    evaluate the diagnostic a accuracy of FibroTest in selecting liver grafts before retrieval in DBD by comparing with 1) histological data obtained with liver biopsy (degree of steatosis, degree of fibrosis) and with 2) CAPTM/LS
  • Steatosis measurement [ Time Frame: 1 Day ]
    evaluate the diagnostic a accuracy of SteatoTest in selecting liver grafts before retrieval in DBD by comparing with 1) histological data obtained with liver biopsy (degree of steatosis, degree of fibrosis) and with 2) CAPTM/LS
  • Fibrosis measurement [ Time Frame: 1 month ]
    Determination of the short-term prognostic values of FibroTest in terms of survival of liver grafts at one month after transplantation
  • Steatosis measurement [ Time Frame: 1 month ]
    Determination of the short-term prognostic values of SteatoTest in terms of survival of liver grafts at one month after transplantation
  • Fibrosis measurement [ Time Frame: 1 year ]
    Determination of the short-term prognostic values of FibroTest in terms of survival of liver grafts at one year after transplantation
  • Steatosis measurement [ Time Frame: 1 year ]
    Determination of the short-term prognostic values of SteatoTest in terms of survival of liver grafts at one year after transplantation


Original Secondary Outcome: Same as current

Information By: University Hospital, Limoges

Dates:
Date Received: May 13, 2015
Date Started: February 2015
Date Completion: December 2018
Last Updated: March 29, 2017
Last Verified: March 2017