APCext : Effect of Temporary Porto-caval Shunt During Liver Transplantation on Function of Liver Graft From Extended Criteria Donor

Liver Transplantation Clinical Trial

— APCext  

Official title:

APCext : Effect of Temporary Porto-caval Shunt During Liver Transplantation on Function of Liver Graft From Extended Criteria Donor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02784119
• Other study ID #: 2016-A00612-49
• Secondary ID: 35RC15_8975
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2017
• Est. completion date: July 2025

Study information

• Verified date: June 2023
• Source: Rennes University Hospital
• Contact: Michel RAYAR, MD, PhD
• Phone: 02 99 28 42 65
• Email: michel.rayar[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 214
• Est. completion date: July 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Procedure:
• temporary porto-caval shunt
temporary porto-caval shunt

Locations

Country	Name	City	State
France	CHU Bordeaux	Bordeaux
France	Hospices Civils Lyon	Lyon
France	CHU Rennes	Rennes
France	CHU Toulouse	Toulouse
France	CHU Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of early allograft dysfunction	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	on postoperative day 7
Primary	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
Primary	Incidence of primary non function	defined by the presence of at least one of the following criteria: Graft's death or retransplantation; Patient's death	within the 7 first postoperative day
Secondary	Realisation of intra-operative transfusion	defined by the transfusion needs of fresh frozen plasma, red blood cell and platelet pool	during the operation
Secondary	Incidence of reperfusion syndrome	defined as decrease of 30% of the median arterial pressure	during the 5 minutes following revascularisation
Secondary	Duration of surgery		at day 0
Secondary	Liver graft function	evaluated by the Model for Early Allograft Function (MEAF) score	within 3 months
Secondary	Occurrence of a severe postoperative complication	defined as a Clavien-Dindo classification > 2	within 3 months
Secondary	Evaluation of urinary function	defined by: Measuring postoperative creatinine level (mg/L); Need of renal dialysis	within the first 7 days
Secondary	Graft's survival	defined by graft's death or retransplantation	at 3 months
Secondary	Patient's survival	defined by patient's death	at 3 months