A Multicenter Randomized Controlled Trial to Compare the Efficacy of End-ischemic Dual Hypothermic Oxygenated Perfusion with Standard Static Cold Storage of Liver Grafts Donated after Circulatory Death in Preventing Non-anastomotic Biliary Strictures after Transplantatio
- Conditions
- End-stage liver disease100179431001965410019818
- Registration Number
- NL-OMON47263
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
- Adult patients (>= 18 years old) with end-stage liver disease
- Signed informed consent
- Willing and able to attend follow-up examinations
- Donor liver graft from a controlled donation after circulatory death (Maastricht category III)
- Donors with a body weight >=40 kg
- Simultaneous participation in another clinical trial that might possibly influence this trial
- Mental conditions rendering the subject incapable to understand the nature, scope and consequences of the trial
- Listed for liver transplantation due to fulminant liver failure or retransplantation because of PNF
- Recipient positive test for HIV
- Donor positive for HIV, Hepatitis B or C
- Patients with contra-indications for MRCP (i.e. pacemaker)
- Patients with simultaneous transplantation of another organ
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The incidence and severity of NAS as diagnosed by an Adjudication committee<br /><br>(who are blinded for the group assignment) by means of magnetic resonance<br /><br>cholangiopancreatography (MRCP) at six months after DCD liver transplantation. </p><br>
- Secondary Outcome Measures
Name Time Method