Clinical trial NCT02784119: APCext : Effect of Temporary Porto-caval Shunt During Liver Transplantation on Function of Liver Graft From Extended Criteria Donor
Official title: APCext : Effect of Temporary Porto-caval Shunt During Liver Transplantation on Function of Liver Graft From Extended Criteria Donor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Transplantation
Keywords: temporary porto-caval shunt
liver graft
extended criteria donor
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2016-05-26
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of early allograft dysfunction
timeFrame: on postoperative day 7
measure: Incidence of early allograft dysfunction
timeFrame: within the 7 first postoperative day
measure: Incidence of primary non function
timeFrame: within the 7 first postoperative day
Secondary outcomes:
measure: Realisation of intra-operative transfusion
timeFrame: during the operation
measure: Incidence of reperfusion syndrome
timeFrame: during the 5 minutes following revascularisation
measure: Duration of surgery
timeFrame: at day 0
measure: Liver graft function
timeFrame: within 3 months
measure: Occurrence of a severe postoperative complication
timeFrame: within 3 months
measure: Evaluation of urinary function
timeFrame: within the first 7 days
measure: Graft's survival
timeFrame: at 3 months
measure: Patient's survival
timeFrame: at 3 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Lyon
country: France
facility: Hospices Civils Lyon
city: Nice
country: France
facility: CHU Nice
city: Rennes
country: France
facility: CHU Rennes
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHU Tours
Study officials:
References: