Liver TransplantationAPCextNCT02784119
APCext : Effect of Temporary Porto-caval Shunt During Liver Transplantation on Function of Liver Graft From Extended Criteria Donor
A study testing temporary porto-caval shunt in people with Liver Transplantation, run by Rennes University Hospital at 6 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- temporary porto-caval shunt
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 6 sitesFrance
- Study dates
- 28 Mar 2017to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 20Show fewer
- 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
Who cannot join
- Complete portal vein thrombosis found during procedure
- Split liver graft
- Realisation of a bilio-enteric anastomosis
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
CHU Bordeaux
Bordeaux
Laurence CHICHE, MD, PhD
- Recruiting
Hospices Civils Lyon
Lyon
Jean-Yves MABRUT, MD, PhD
- Recruiting
CHU Nice
Nice
Damien MASSALOU
- Recruiting
CHU Rennes
Rennes
Michel RAYAR, Md, PhD
Karim BOUDJEMA, Md, PhD
- Recruiting
CHU Toulouse
Toulouse
Fabrice MUSCARI, MD, PhD
- Recruiting
CHU Tours
Tours
Louise BARBIER
About this study
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).
Read more
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.
- Conditions
- Liver Transplantation
- Being tested
- temporary porto-caval shunt
- Keywords
- temporary porto-caval shunt, liver graft, extended criteria donor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temporary porto-caval shuntProcedure or surgery
temporary porto-caval shunt
| Study group | Role | What they receive |
|---|---|---|
| temporary porto-caval shunt | Experimental | patients in whom temporary porto-caval shunt is performed during orthotopic liver transplantation Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: within the 7 first postoperative day
Secondary outcomes (8)
Realisation of intra-operative transfusion
defined by the transfusion needs of fresh frozen plasma, red blood cell and platelet pool
Measured: during the operation
Incidence of reperfusion syndrome
defined as decrease of 30% of the median arterial pressure
Measured: during the 5 minutes following revascularisation
Duration of surgery
Measured: at day 0
Liver graft function
evaluated by the Model for Early Allograft Function (MEAF) score
Measured: within 3 months
Occurrence of a severe postoperative complication
defined as a Clavien-Dindo classification > 2
Measured: within 3 months
Evaluation of urinary function
defined by:
- Measuring postoperative creatinine level (mg/L)
- Need of renal dialysis
Measured: within the first 7 days
Graft's survival
defined by graft's death or retransplantation
Measured: at 3 months
Patient's survival
defined by patient's death
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study start28 Mar 2017
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784119
- Sponsor's protocol ID
- 2016-A00612-49
- Other IDs
- 35RC15_8975
- Acronym
- APCext
- Status last verified
- Sep 2024
- First submitted
- 19 May 2016
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APCext : Effect of Temporary Porto-caval Shunt During Liver Transplantation on Function of Liver Graft From Extended Criteria Donor
- ClinicalTrials.gov ID
- NCT02784119
- Acronym / sponsor ID
- APCext / 2016-A00612-49
- Conditions
- Liver Transplantation
- Keywords
- temporary porto-caval shunt, liver graft, extended criteria donor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 26 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| temporary porto-caval shunt | Experimental | Procedure: temporary porto-caval shuntpatients in whom temporary porto-caval shunt is performed during orthotopic liver transplantation |
| no temporary porto-caval shunt | No intervention | –patients in whom temporary porto-caval shunt is not performed during orthotopic liver transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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:
Key exclusion criteria (3 listed)
- Complete portal vein thrombosis found during procedure
- Split liver graft
- Realisation of a bilio-enteric anastomosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| temporary porto-caval shunttemporary porto-caval shunt | Procedure or surgery | temporary porto-caval shunt |
Primary outcome
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
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
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
8 secondary outcomes
Realisation of intra-operative transfusion
Time frame: during the operation
Incidence of reperfusion syndrome
Time frame: during the 5 minutes following revascularisation
Duration of surgery
Time frame: at day 0
Liver graft function
Time frame: within 3 months
Occurrence of a severe postoperative complication
Time frame: within 3 months
Evaluation of urinary function
Time frame: within the first 7 days
Graft's survival
Time frame: at 3 months
Patient's survival
Time frame: at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing temporary porto-caval shunt in people with Liver Transplantation, run by Rennes University Hospital at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michel RAYAR, MD, PhD (02 99 28 42 65, michel.rayar@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of early allograft dysfunction (time frame: on postoperative day 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.