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Liver Metastasis Colon CancerPhase 2HYPER-LIV01NCT03841305

Simultaneous Portal and Hepatic Vein Versus Portal Vein Embolizations for Hypertrophy of the Future Liver Remnant

A Phase 2 study testing Liver preparation before major hepatectomy in people with Liver Metastasis Colon Cancer, run by University Hospital, Montpellier at 12 sites 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 hypothesis is that liver venous deprivation (LVD) could strongly improve hypertrophy of the future remnant liver (FRL) at 3 weeks, as compared to portal vein embolization (PVE) in patient with liver metastases from colo-rectal origin considered as resectable. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Metastasis Colon Cancer
What is being tested?
Liver preparation before major hepatectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
12 sitesFrance
Study dates
29 Apr 2019to 10 Oct 2024
Phase
Phase 2
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

  • Liver metastases from colo-rectal origin considered as resectable (as validated by a multidisciplinary committee with at least one senior hepatic surgeon) provided sufficient FRL volume
  • Percentage of FRL volume < 30%
  • Age ≥ 18 years
  • General health status World Health Organisation 0,1
  • Estimated life expectancy > 3 months
  • Patients whose biological parameters are :
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  • Platelets ≥100,000/mm3,
  • Polynuclear neutrophils ≥ 1000/mm3,
  • Hemoglobin≥ 9g/dL (even transfused patients can be included)
  • Creatininemia < 1.5 times the normal value
  • Creatinine clearance > 30 milliliters (mL)/min
  • Bilirubinemia ≤ 1,5 times the normal value
  • liver transaminases ≤ 5 times the normal value
  • prothrombin rate > 70%
  • Reference liver CT-Scan or MRI done during the 30 days preceding PVE or LVD.
  • Written informed consent
  • National health insurance cover

Who cannot join

  • Patient with cirrhosis
  • Presence of clinical ascites
  • Ongoing participation or participation within the 21 days prior to inclusion in the study in another therapeutic trial with an experimental drug
  • Serious non-stabilized disease, active uncontrolled infection or other serious underlying disorder likely to prevent the patient from receiving the treatment
  • Pregnancy (betaHCG positive), breast-feeding or the absence of effective contraception for women of child-bearing age
  • Contraindication for the MRI : Pacemaker or neurosensorial stimulator or implantable defibrillator, cochlear implant, ferromagnetic foreign body similar to the nervous structure.
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  • Allergy or contra-indication to iodine contrast agents (thyrotoxicosis, allergy to the active substance or excipients)
  • Treatment with anticoagulants (heparin or AVK) that cannot be interrupted for 48 hours
  • Treatment with anti-platelets that cannot be interrupted for 5 days for aspirin or Plavix
  • Legal incapacity (persons in custody or under guardianship)
  • Deprived of liberty Subject (by judicial or administrative decision)
  • Impossibility to sign the informed consent document or to adhere to the medical follow-up of the trial for geographical, social or psychological reasons

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

France12 sites

  • CHU d'Angers

    Angers, 49933

  • Bordeaux University Hospital

    Bordeaux

  • CHU de Dijon

    Dijon, 21079

  • CHU de Grenoble

    Grenoble, 38043

  • Hospices Civils de Lyon

    Lyon, 69317

  • Centre Léon Berard

    Lyon, 69373

  • CHU de Montpellier

    Montpellier, Hérault, 34295

  • CHU de Nice

    Nice, 06202

  • APHP - Cochin hospital

    Paris

  • CHU de Poitiers

    Poitiers, 80000

  • Hôpital Paul Brousse

    Villejuif, 94800

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: Simultaneous Portal and Hepatic Vein Embolization Versus Portal Vein Embolization for Hypertrophy of the Future Liver Remnant Before Major Hepatectomy of Non-cirrhotic Liver : a Multicentric Comparative Randomized Phase II Trial

The hypothesis is that liver venous deprivation (LVD) could strongly improve hypertrophy of the future remnant liver (FRL) at 3 weeks, as compared to portal vein embolization (PVE) in patient with liver metastases from colo-rectal origin considered as resectable.

Read the detailed description

Portal vein embolization (PVE) has been widely used to generate hypertrophy of the nonembolized lobe in patients undergoing major hepatectomy in order to prevent small-for-size remnant liver resulting in post-operative liver insufficiency.

Although PVE is a safe and effective procedure, it does not always induce sufficient hypertrophy of the future remnant liver (FRL) even after a long time. In case of insufficient liver regeneration following PVE, some authors suggested to embolize hepatic vein(s) (Hwang, Ann Surg 2009).

Interestingly, the sequential right hepatic vein embolization (HVE) after right PVE demonstrated an incremental effect on the FRL. Although attractive, this approach requires two different procedures and does not spare time as compared to PVE alone.

To shorten and optimize the phase of liver preparation before surgery,the so-called liver venous deprivation (LVD) technique that combines both PVE and HVE during the same procedure was developed.

The aim of this randomized phase II trial is to compare the percentage of change in FRL volume at 3 weeks after LVD or PVE using MRI or CT-scan.

Being tested
Liver preparation before major hepatectomy
Keywords
Liver, Interventional radiology, Portal vein embolization, Portal and hepatic vein embolization, Future liver remnant, Surgery, Non-cirrhotic liver, Liver metastases, Colorectal cancer, Liver Regeneration, Liver resection
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • Liver preparation before major hepatectomyProcedure or surgery

    Simultaneous portal and hepatic vein embolization versus Portal vein embolization, also called venous deprivation OR portal vein embolization.

Study groups in NCT03841305
Study groupRoleWhat they receive
portal vein embolizationActive comparatorLiver preparation before major hepatectomy : portal vein embolization (PVE) in patient with liver metastases from colo-rectal origin considered as resectable.
Receives: Procedure: Liver preparation before major hepatectomy
liver venous deprivationExperimentalLiver preparation before major hepatectomy : Patients with the liver venous deprivation (LVD) technique that combines both PVE and hepatic vein embolization (HVE) during the same procedure.
Receives: Procedure: Liver preparation before major hepatectomy

What is being measured

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

  1. increase in volume of the future remnant liver (FRL)

    The primary outcomes is to compare the increase in volume of the future remnant liver (FRL)

    Measured: at 3 weeks after liver venous deprivation (LVD) or portal vein embolization (PVE) using MRI or CT-scan

Secondary outcomes (15)

  1. Tolerance

    Toxicities are evaluated according to NCI-CTCAE version 4.03 published 14 June 2010

    Measured: between the day of liver preparation and 90 days after surgery

  2. Post-operative mortality

    Post-operative mortality defined as any death within 90 days after surgery or within the hospital stay

    Measured: 90 days after surgery

  3. Post-operative morbidity

    Post-operative morbidity defined as the percentages of grade I/II/III/IV/V complications according to Clavien-Dindo classification within the 90 days after surgery or within the hospital stay.

    Measured: 90 days after surgery

  4. Post-hepatectomy liver failure

    Post-hepatectomy liver failure defined according to the "50-50" criteria or peak bilirubin >7mg/dL.

    Measured: between the day of the surgery and 90 days after surgery

  5. Rate of non-resectability due to insufficient FRL

    Rate of non-resectability due to insufficient FRL defined as the percentage of patients for whom resection will be not attempted due to insufficient FRL

    Measured: between the day of the treatment and the day of the surgery

  6. Rate of non-resectability due to tumor progression

    Rate of non-resectability due to tumor progression defined as the percentage of patients for whom resection will not be attempted due to tumor progression.

    Measured: between the day of the treatment and the day of the surgery

  7. Rate of per-operative difficulties

    Rate of per-operative difficulties defined as the percentage of patients for whom per-operative difficulties are encountered by the surgeon

    Measured: between the day of the surgery and 90 days after surgery

  8. Blood loos, operating time, transfusion

    Blood loss are evaluated in mL. Operating time avec evaluated in minutes and transfusion are evaluated by number of packed red blood cells

    Measured: the day of the surgery

  9. R0 resection rate

    Rate of R0 resection defined as no microscopic tumor residual

    Measured: the day of the surgery

  10. R1 resection rate

    Rate of R1 resection defined as the percentage of patients resected with margin <1mm

    Measured: the day of the surgery

  11. Pre and post-operative liver volumes

    Pre and post-operative liver volumes will be evaluated through CT or MRI acquisitions by calculating whole liver, tumor and FRL volumes

    Measured: Baseline, week 1, week 3 then every 2 weeks until surgery or week 7 and 4 weeks after surgery

  12. Recurrence-free survival

    Recurrence-free survival defined as the time from date of randomization to date of recurrence or death from their tumor. Patients alive will be censored at the date of last news.

    Measured: 90 days after surgery

  13. Overall survival

    Overall survival defined as the time from date of randomization to date of death from any cause. Patients alive will be censored at the date of last news.

    Measured: Between the liver preparation and 90 days after surgery

  14. Evaluation of pre and post-operative liver function

    Evaluation of pre and post-operative liver function will be evaluated using 99mTc mebrofenine scintigraphy through SPECT/CT acquisitions by calculating mebrofenin clearance in %/min/m² of whole liver and FRL at the same time points as CT/MRI

    Measured: Baseline, week 1, week 3 then every 2 weeks until surgery or week 7 and 4 weeks after surgery

  15. To search for biomarkers predictive of liver hypertrophy/regeneration and immune cell response

    Biomarkers predictive of liver hypertrophy/regeneration are evaluated by blood samples and liver biopies

    Measured: The day of liver preparation, on day 1, day 2 and day 3 after liver preparation and the day of surgery

Timeline

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

  1. First posted15 Feb 2019
  2. Study start29 Apr 2019
  3. Primary completion10 Oct 2024
  4. Study completion10 Oct 2024

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03841305
Sponsor's protocol ID
RECHMPL18_0025
Other IDs
UF 7595
Acronym
HYPER-LIV01
Status last verified
Jan 2025
First submitted
13 Feb 2019
Last updated
3 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Deshayes E, Piron L, Bouvier A, Lapuyade B, Lermite E, Vervueren L, Laurent C, Pinaquy JB, Chevallier P, Dohan A, Rode A, Sengel C, Guillot C, Quenet F, Guiu B. Study protocol of the HYPER-LIV01 trial: a multicenter phase II, prospective and randomized study comparing simultaneous portal and hepatic vein embolization to portal vein embolization for hypertrophy of the future liver remnant before major hepatectomy for colo-rectal liver metastases. BMC Cancer. 2020 Jun 19;20(1):574. doi: 10.1186/s12885-020-07065-z.

    PubMed 32560632

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Liver preparation before major hepatectomy in people with Liver Metastasis Colon Cancer, run by University Hospital, Montpellier at 12 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 17 inclusion and 12 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 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

increase in volume of the future remnant liver (FRL) (time frame: at 3 weeks after liver venous deprivation (LVD) or portal vein embolization (PVE) using MRI or CT-scan). 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 NCT03841305, 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 3 Jan 2025.

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