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

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ClinicalTrials.gov Identifier: NCT02784119
Recruitment Status : Recruiting
First Posted : May 26, 2016
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Liver Transplantation Procedure: temporary porto-caval shunt Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: APCext : Effect of Temporary Porto-caval Shunt During Liver Transplantation on Function of Liver Graft From Extended Criteria Donor
Actual Study Start Date : March 28, 2017
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: temporary porto-caval shunt
patients in whom temporary porto-caval shunt is performed during orthotopic liver transplantation
Procedure: temporary porto-caval shunt
temporary porto-caval shunt

No Intervention: no temporary porto-caval shunt
patients in whom temporary porto-caval shunt is not performed during orthotopic liver transplantation



Primary Outcome Measures :
  1. Incidence of early allograft dysfunction [ Time Frame: 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

  2. Incidence of early allograft dysfunction [ Time Frame: 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


  3. Incidence of primary non function [ Time Frame: 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 :
  1. Realisation of intra-operative transfusion [ Time Frame: during the operation ]
    defined by the transfusion needs of fresh frozen plasma, red blood cell and platelet pool

  2. Incidence of reperfusion syndrome [ Time Frame: during the 5 minutes following revascularisation ]
    defined as decrease of 30% of the median arterial pressure

  3. Duration of surgery [ Time Frame: at day 0 ]
  4. Liver graft function [ Time Frame: within 3 months ]
    evaluated by the Model for Early Allograft Function (MEAF) score

  5. Occurrence of a severe postoperative complication [ Time Frame: within 3 months ]
    defined as a Clavien-Dindo classification > 2

  6. Evaluation of urinary function [ Time Frame: within the first 7 days ]

    defined by:

    • Measuring postoperative creatinine level (mg/L)
    • Need of renal dialysis

  7. Graft's survival [ Time Frame: at 3 months ]
    defined by graft's death or retransplantation

  8. Patient's survival [ Time Frame: at 3 months ]
    defined by patient's death



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02784119


Contacts
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Contact: Michel RAYAR, MD, PhD 02 99 28 42 65 michel.rayar@chu-rennes.fr
Contact: Anne GANIVET 02 99 28 25 55 anne.ganivet@chu-rennes.fr

Locations
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France
CHU Bordeaux Recruiting
Bordeaux, France
Principal Investigator: Laurence CHICHE, MD, PhD         
Hospices Civils Lyon Recruiting
Lyon, France
Principal Investigator: Jean-Yves MABRUT, MD, PhD         
CHU Rennes Recruiting
Rennes, France
Principal Investigator: Michel RAYAR, Md, PhD         
Sub-Investigator: Karim BOUDJEMA, Md, PhD         
Sub-Investigator: Laurent SULPICE, Md, PhD         
Sub-Investigator: Christophe CAMUS, Md, PhD         
Sub-Investigator: Pauline HOUSSEL-DEBRY, Md, PhD         
CHU Toulouse Recruiting
Toulouse, France
Principal Investigator: Fabrice MUSCARI, MD, PhD         
CHU Tours Not yet recruiting
Tours, France
Sponsors and Collaborators
Rennes University Hospital
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02784119    
Other Study ID Numbers: 2016-A00612-49
35RC15_8975 ( Other Identifier: CHU Rennes )
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rennes University Hospital:
temporary porto-caval shunt
liver graft
extended criteria donor