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Completed

NCT Number: NCT02945059

Reversible Portal Vein Embolization Before Major Hepatectomy

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antoine Béclère

Clamart, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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…)
  • 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).

Treatment and study plan

Selective reversible portal vein embolization

Procedure

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.

Primary outcomes

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

    Time frame: 4-6 weeks after portal vein embolization

    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

Secondary outcomes

  1. Technical feasibility: Percentage of completed PVE

    Time frame: During the procedure of portal vein embolization

    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.

  2. Technical feasibility: Percentage of partially completed PVE

    Time frame: During the procedure of portal vein embolization

    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.

  3. Technical feasibility: Percentage of not performed PVE

    Time frame: During the procedure of portal vein embolization

    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.

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

    Time frame: During PVE and within 6 weeks after embolization

    Portal thrombosis, pulmonary embolism and other complications

  5. Liver tolerance

    Time frame: At Day0, Day1 and Day7 after portal vein embolization

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

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

    Time frame: 4-6 weeks after portal vein embolization

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

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

    Time frame: Through study completion, an average of 14 months

    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.

  8. Rate of patients that finally undergo surgery

    Time frame: Through study completion, an average of 14 months

    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.

  9. Inflammation and adhesions during portal pedicles dissection

    Time frame: During liver surgery.

    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.

  10. Intraoperative morbidity.

    Time frame: Up to 90 days following liver surgery.

    Liver failure and other complications due to surgery.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: EMBORES

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Oct 26, 2016
Registry last updated
Jan 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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