NCT02784119

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 26, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

March 28, 2017

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

September 23, 2024

Status Verified

September 1, 2024

Enrollment Period

8.3 years

First QC Date

May 19, 2016

Last Update Submit

September 20, 2024

Conditions

Liver Transplantation

Keywords

temporary porto-caval shuntliver graftextended criteria donor

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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: * Graft's death or retransplantation * Patient's death

    within the 7 first postoperative day

Secondary Outcomes (8)

  • Realisation of intra-operative transfusion

    during the operation

  • Incidence of reperfusion syndrome

    during the 5 minutes following revascularisation

  • Duration of surgery

    at day 0

  • Liver graft function

    within 3 months

  • Occurrence of a severe postoperative complication

    within 3 months

  • +3 more secondary outcomes

Study Arms (2)

temporary porto-caval shunt

EXPERIMENTAL

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

Procedure: temporary porto-caval shunt

no temporary porto-caval shunt

NO INTERVENTION

patients in whom temporary porto-caval shunt is not performed during orthotopic liver transplantation

Interventions

temporary porto-caval shuntPROCEDURE

temporary porto-caval shunt

temporary porto-caval shunt

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Fulminant hepatitis
  • +4 more criteria

You may not qualify if:

  • Complete portal vein thrombosis found during procedure
  • Split liver graft
  • Realisation of a bilio-enteric anastomosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CHU Bordeaux

Bordeaux, France

RECRUITING

Hospices Civils Lyon

Lyon, France

RECRUITING

CHU Nice

Nice, France

RECRUITING

CHU Rennes

Rennes, France

RECRUITING

CHU Toulouse

Toulouse, France

RECRUITING

CHU Tours

Tours, France

RECRUITING

Central Study Contacts

Michel RAYAR, MD, PhD

CONTACT

02 99 28 42 65michel.rayar@chu-rennes.fr

Anne GANIVET

CONTACT

02 99 28 25 55anne.ganivet@chu-rennes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2016

First Posted

May 26, 2016

Study Start

March 28, 2017

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

September 23, 2024

Record last verified: 2024-09

Locations

FR(6)