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

Not Applicable

Recruiting

• Conditions: Liver Transplantation
• Interventions: Procedure: temporary porto-caval shunt

• Registration Number: NCT02784119
• Lead Sponsor: Rennes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-19
• Study First Submitted QC: 2016-05-23
• Study First Posted: 2016-05-26
• Study Start: 2017-03-28
• Status Verified: 2023-06
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-06
• Primary Completion: 2024-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 214

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
temporary porto-caval shunt	temporary porto-caval shunt	patients in whom temporary porto-caval shunt is performed during orthotopic liver transplantation

Primary Outcome Measures

Name	Time	Method
Incidence of early allograft dysfunction	within the 7 first postoperative day	defined by the presence of at least one of the following criteria: • ASAT or ALAT level \> 2000 IU/mL
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 Outcome Measures

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

Trial Locations

Locations (6)

CHU Nice; 🇫🇷 Nice, France

CHU Bordeaux; 🇫🇷 Bordeaux, France

Hospices Civils Lyon; 🇫🇷 Lyon, France

CHU Rennes; 🇫🇷 Rennes, France

CHU Toulouse; 🇫🇷 Toulouse, France

CHU Tours; 🇫🇷 Tours, France