Liver Transplantation
Conditions
Keywords
temporary porto-caval shunt, liver graft, extended criteria donor
Brief summary
The success of orthotopic liver transplantation (OLT) in treatment of liver malignancy and endstage liver disease has led to an increase in the gap between patients on waiting-lists and available liver grafts. In order to compensate for this scarcity, use of liver grafts harvested from extended criteria donors (ECD) has become more and more frequent. However, these ECD grafts are known to be associated with a higher rate of primary non function (PNF) or early allograft dysfunction (EAD) because of a greater vulnerability to ischemia-reperfusion injury (IRI). During OLT, the clamping of the portal vein induces blood congestion in the splanchnic territory leading to increased gut permeability, bacterial translocation and release of endotoxin and pro-inflammatory cytokines at revascularisation, which exacerbate IRI. Realisation of a temporary porto-caval shunt (TPCS) (i.e. end to side anastomosis between the portal vein and infrahepatic vena cava) during the anhepatic phase, avoids splanchnic congestion and could therefore decrease IRI and improve liver graft function. However, TPCS remains poorly used as no randomised trial succeeds to show its benefit on liver function due to lack of power.
Interventions
PROCEDUREtemporary porto-caval shunt
temporary porto-caval shunt
Sponsors
Rennes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years old * Candidate of liver transplantation * With cirrhosis from any etiology * Model For End-Stage Liver Disease (MELD) score \< 25 * Transplanted with a liver graft harvested from an extended criteria donor defined as presence of at least one of the following criteria: * Donor age \> 65 years old * Intensive care unit stay \> 7 days * BMI \> 30 * Natremia \> 155 mmol/L * Aspartate aminotransferase (ASAT) \> 150 IU/mL * Alanine aminotransferase (ALAT) \> 170 IU/mL * Occurrence of a cardiac arrest before graft harvesting * Proven biopsy macrosteathosis \> 30% * Non-opposition from the patient Non Inclusion Criteria: * Fulminant hepatitis * Retransplantation * Combined organ transplantation (kidney, pancreas, heart, lung) * Non heart beating donor * Complete portal vein thrombosis on preoperative imaging finding
Exclusion criteria
* Complete portal vein thrombosis found during procedure * Split liver graft * Realisation of a bilio-enteric anastomosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of early allograft dysfunction | on postoperative day 7 | defined by the presence of at least one of the following criteria: * Bilirubin level \> 10 mg/dL (i.e. 171 µmol/L) * International Normalized Ratio \> 1.6 |
| Incidence of primary non function | within the 7 first postoperative day | defined by the presence of at least one of the following criteria: * Graft's death or retransplantation * Patient's death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of surgery | at day 0 | — |
| Liver graft function | within 3 months | evaluated by the Model for Early Allograft Function (MEAF) score |
| Occurrence of a severe postoperative complication | within 3 months | defined as a Clavien-Dindo classification \> 2 |
| Realisation of intra-operative transfusion | during the operation | defined by the transfusion needs of fresh frozen plasma, red blood cell and platelet pool |
| Graft's survival | at 3 months | defined by graft's death or retransplantation |
| Patient's survival | at 3 months | defined by patient's death |
| Evaluation of urinary function | within the first 7 days | defined by: * Measuring postoperative creatinine level (mg/L) * Need of renal dialysis |
| Incidence of reperfusion syndrome | during the 5 minutes following revascularisation | defined as decrease of 30% of the median arterial pressure |
Countries
France
Contacts
Primary ContactMichel RAYAR, MD, PhD
Backup ContactAnne GANIVET
Outcome results
None listed