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| ID | Type | Description | Link |
|---|---|---|---|
| 35RC15_8975 | Other Identifier | CHU Rennes |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| temporary porto-caval shunt | Experimental | patients in whom temporary porto-caval shunt is performed during orthotopic liver transplantation |
|
| no temporary porto-caval shunt | No Intervention | patients in whom temporary porto-caval shunt is not performed during orthotopic liver transplantation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| temporary porto-caval shunt | Procedure | temporary porto-caval shunt |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of early allograft dysfunction | defined by the presence of at least one of the following criteria:
| on postoperative day 7 |
| Incidence of early allograft dysfunction | defined by the presence of at least one of the following criteria: • ASAT or ALAT level > 2000 IU/mL | within the 7 first postoperative day |
| Incidence of primary non function | defined by the presence of at least one of the following criteria:
| within the 7 first postoperative day |
| Measure | Description | Time Frame |
|---|---|---|
| Realisation of intra-operative transfusion | defined by the transfusion needs of fresh frozen plasma, red blood cell and platelet pool | during the operation |
| Incidence of reperfusion syndrome | defined as decrease of 30% of the median arterial pressure |
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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:
Non-opposition from the patient
Non Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michel RAYAR, MD, PhD | Contact | 02 99 28 42 65 | michel.rayar@chu-rennes.fr | |
| Anne GANIVET | Contact | 02 99 28 25 55 | anne.ganivet@chu-rennes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bordeaux | Recruiting | Bordeaux | France |
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| during the 5 minutes following revascularisation |
| Duration of surgery | at day 0 |
| Liver graft function | evaluated by the Model for Early Allograft Function (MEAF) score | within 3 months |
| Occurrence of a severe postoperative complication | defined as a Clavien-Dindo classification > 2 | within 3 months |
| Evaluation of urinary function | defined by:
| within the first 7 days |
| Graft's survival | defined by graft's death or retransplantation | at 3 months |
| Patient's survival | defined by patient's death | at 3 months |
| Hospices Civils Lyon | Recruiting | Lyon | France |
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| CHU Nice | Recruiting | Nice | France |
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| CHU Rennes | Recruiting | Rennes | France |
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| CHU Toulouse | Recruiting | Toulouse | France |
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| CHU Tours | Recruiting | Tours | France |
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