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Liver RegenerationEMBORESNCT02945059

Reversible Portal Vein Embolization Before Major Hepatectomy

A study testing Selective reversible portal vein embolization in people with Liver Regeneration and Reversible Portal Vein Embolization, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to prospectively evaluate the tolerance and efficiency of a new technique of preoperative selective portal vein embolization (PVE) in patients requiring major hepatic resection. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Selective reversible portal vein embolization
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteFrance
Study dates
15 Jan 2018to 26 Apr 2022
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient aged between 18 and 80 years
  • Patient requiring major liver resection (at least 3 segments)
  • PVE indication decided in a multidisciplinary meeting
  • Patients who are able to understand and follow instructions and who are able to participate in the study for the entire period
  • Patients must have given their written informed consent to participate in the study after having received adequate previous information and prior to any study-specific procedures
  • Patient affiliated to the French National Social Security System

Who cannot join

  • American Score of Anesthesiologist (ASA) > 3
  • Extensive Portal vein or hepatic vein thrombosis
  • Patient not covered by social security service
  • Patient under guardianship
  • Patients with a medical disorder, condition, or history of such that would impair the patient's ability to participate or complete this study in the opinion of the investigator.
  • Patients who have already had anaphylactic or anaphylactoid reactions during the injection of iodinated contrast medium (edema of Quincke…)
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  • Patients with an allergy to pork products During the hospitalization and before the PVE
  • Severe renal insufficiency (glomerular filtration rate ≤ 30mL/min eg calculated based on the Cockcroft formula).
  • Pregnant women, or breast feeding women, or women with childbearing potential not using a combination of condoms and a safe and highly effective contraception method during the participation to the research (hormonal contraception with implants or oral contraceptives, or intrauterine devices).

Trial locations and contacts

1 site in 1 country.

France1 site

  • Antoine Béclère

    Clamart

Other trials in France

About this study

Official title: Multicentric Prospective Study Assessing the Efficiency of Preoperative Reversible Selective Portal Vein Embolization in Patients Requiring Major Hepatic Resection

The aim of this study is to prospectively evaluate the tolerance and efficiency of a new technique of preoperative selective portal vein embolization (PVE) in patients requiring major hepatic resection.

Read the detailed description

Portal vein embolization (PVE) is used before major hepatectomy to induce hypertrophy of the future liver remnant (FLR). A non-reversible absorbable material is generally used for embolization, as it provides effective, permanent vascular occlusion. Our team has developed a minimally invasive technique of reversible PVE using gelfoam powder. The aim of this study is to assess the tolerance and efficiency of preoperative reversible selective PVE in patients requiring major hepatic resection. We hypothesize that preoperative reversible PVE allows to similarly increase FLR volume in comparison with classical non-reversible PVE in patients requiring major liver resection with limited FLR.

The hypertrophy ratio after classical non-reversible PVE is evaluated in literature as 13%. We estimated the hypertrophy ratio after reversible PVE as 9% in a previous retrospective study.

The aim of this pilot study is to prospectively evaluate the hypertrophy ratio after reversible PVE.

Primary End Point: Hypertrophy ratio of FLR volume / total liver volume between the baseline and after PVE, assessed by computed tomography scan volumetry 4-6 weeks after PVE.

Being tested
Selective reversible portal vein embolization
Keywords
Liver regeneration, portal vein embolization, gelatin powder, liver surgery, hepatectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Selective reversible portal vein embolizationProcedure or surgery

    Percutaneous access to the portal vein is achieved under general anesthesia with ultrasound or fluoroscopic control. After assessment of portal venous anatomy, embolization of selected portal vein segments is performed using the powdered form of an absorbable gelatin sponge.

Study groups in NCT02945059
Study groupRoleWhat they receive
1ExperimentalPatients will undergo reversible PVE before major hepatic resection.
Receives: Procedure: Selective reversible portal vein embolization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hypertrophy ratio of FLR volume / total liver volume between the baseline and after the PVE

    Ratio is evaluated by computed tomography scan volumetry 4-6 weeks after portal vein embolization.Volumes will be assessed by one independent blind observer, from anonymized CT scan series. Total, non-embolized (FLR) volume and embolized liver volume (ELV) will be measured.

    The following formulas will be used to calculate percentage of FLR volume:

    • FLR volume prePVE = (FLR prePVE volume / (total liver prePVE volume - tumor volume prePVE)) x 100
    • FLR volume postPVE = (FLR postPVE volume / (total liver postPVE volume - tumor volume postPVE)) x 100

    The following formulas will be used to calculate hypertrophy ratio:

    %FLR volume postPVE - %FLR volume prePVE

    Measured: 4-6 weeks after portal vein embolization

Secondary outcomes (10)

  1. Technical feasibility: Percentage of completed PVE

    Percutaneous access to the portal vein is achieved under general anesthesia with ultrasound or fluoroscopic control. Venous cartography of the liver is achieved with fluoroscopic control. PVE technique remains unchanged but a mixture of absorbable embolization agent is injected.

    Adverse events will be questioned and documented in the electronic Case Report Form.

    Measured: During the procedure of portal vein embolization

  2. Technical feasibility: Percentage of partially completed PVE

    Percutaneous access to the portal vein is achieved under general anesthesia with ultrasound or fluoroscopic control. Venous cartography of the liver is achieved with fluoroscopic control. PVE technique remains unchanged but a mixture of absorbable embolization agent is injected.

    Adverse events will be questioned and documented in the electronic Case Report Form.

    Measured: During the procedure of portal vein embolization

  3. Technical feasibility: Percentage of not performed PVE

    Percutaneous access to the portal vein is achieved under general anesthesia with ultrasound or fluoroscopic control. Venous cartography of the liver is achieved with fluoroscopic control. PVE technique remains unchanged but a mixture of absorbable embolization agent is injected.

    Adverse events will be questioned and documented in the electronic Case Report Form.

    Measured: During the procedure of portal vein embolization

  4. Per and post procedure (within 6 weeks) morbidity

    Portal thrombosis, pulmonary embolism and other complications

    Measured: During PVE and within 6 weeks after embolization

  5. Liver tolerance

    Liver function tests at Day0, Day1 and Day7 after portal vein embolization

    Measured: At Day0, Day1 and Day7 after portal vein embolization

  6. Rate of portal partial and complete recanalization (subsegmental, segmental and sectorial)

    During CT scan series performed 4 to 6 weeks after PVE, portal venous tree patency will be assessed by one independent blind observer.

    Measured: 4-6 weeks after portal vein embolization

  7. Rate of patients considered after portal vein embolization for surgery in their centers

    All patients who underwent PVE procedure with sufficiently hypertrophy of non-embolized liver segments will return to hospital in order to undergo liver surgery. Decision to proceed with surgery will be left on investigator's discretion.

    Measured: Through study completion, an average of 14 months

  8. Rate of patients that finally undergo surgery

    All patients who underwent PVE procedure with sufficiently hypertrophy of non-embolized liver segments will return to hospital in order to undergo liver surgery. Decision to proceed with surgery will be left on investigator's discretion.

    Measured: Through study completion, an average of 14 months

  9. Inflammation and adhesions during portal pedicles dissection

    Assessment of the level of inflammation and adhesions will be performed during portal pedicles dissection. The senior surgeon will evaluate the level of inflammation and adhesions during portal pedicles dissection using a quantitative scale.

    Measured: During liver surgery.

  10. Intraoperative morbidity.

    Liver failure and other complications due to surgery.

    Measured: Up to 90 days following liver surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2016 (estimated)
  2. Study start15 Jan 2018
  3. Primary completion26 Apr 2022
  4. Study completion26 Apr 2022

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Reversible Portal vein embolization (PVE) using curaspon® (Absorbable Gelatin Hemostats)
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02945059
Sponsor's protocol ID
P150953
Acronym
EMBORES
Status last verified
Jan 2024
First submitted
17 Oct 2016
Last updated
24 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tranchart H, Maitre S, Girard E, Ghelfi J, Gelli M, Tselikas L, Barat M, Fuks D, Sarran A, Benoist S, Meyrignac O, Sepulveda A, Ronot M, Pou M, Chirica M, Dagher I; EMBORES Study Group. Efficacy and safety of temporary selective portal vein embolization before major hepatectomy (EMBORES): a phase 2 trial. EClinicalMedicine. 2026 Oct 12;101:104262. doi: 10.1016/j.eclinm.2026.104262. eCollection 2026 Nov.

    PubMed 42903458

Questions about this trial

What is this clinical trial studying?

A study testing Selective reversible portal vein embolization in people with Liver Regeneration and Reversible Portal Vein Embolization, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hypertrophy ratio of FLR volume / total liver volume between the baseline and after the PVE (time frame: 4-6 weeks after portal vein embolization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02945059, which also lists 1 linked publication.

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 24 Jan 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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