Simultaneous Portal and Hepatic Vein Versus Portal Vein Embolizations for Hypertrophy of the Futu… (NCT03841305) | Clinical Trial Compass
CompletedPhase 2
Simultaneous Portal and Hepatic Vein Versus Portal Vein Embolizations for Hypertrophy of the Future Liver Remnant
France64 participantsStarted 2019-04-29
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 :
* 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
Exclusion criteria
* 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 defibrilla…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
increase in volume of the future remnant liver (FRL)
Timeframe: at 3 weeks after liver venous deprivation (LVD) or portal vein embolization (PVE) using MRI or CT-scan