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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 22
- 主要终点
- increase in volume of the future remnant liver (FRL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 defibrillator, cochlear implant, ferromagnetic foreign body similar to the nervous structure.
- •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
排除标准
- 未提供
结局指标
主要结局
increase in volume of the future remnant liver (FRL)
时间窗: at 3 weeks after liver venous deprivation (LVD) or portal vein embolization (PVE) using MRI or CT-scan
The primary outcomes is to compare the increase in volume of the future remnant liver (FRL)
次要结局
- Post-operative morbidity(90 days after surgery)
- To search for biomarkers predictive of liver hypertrophy/regeneration and immune cell response(The day of liver preparation, on day 1, day 2 and day 3 after liver preparation and the day of surgery)
- Rate of non-resectability due to insufficient FRL(between the day of the treatment and the day of the surgery)
- Rate of non-resectability due to tumor progression(between the day of the treatment and the day of the surgery)
- Rate of per-operative difficulties(between the day of the surgery and 90 days after surgery)
- R0 resection rate(the day of the surgery)
- Post-operative mortality(90 days after surgery)
- Recurrence-free survival(90 days after surgery)
- Evaluation of pre and post-operative liver function(Baseline, week 1, week 3 then every 2 weeks until surgery or week 7 and 4 weeks after surgery)
- Tolerance(between the day of liver preparation and 90 days after surgery)
- Post-hepatectomy liver failure(between the day of the surgery and 90 days after surgery)
- R1 resection rate(the day of the surgery)
- Overall survival(Between the liver preparation and 90 days after surgery)
- Blood loos, operating time, transfusion(the day of the surgery)
- Pre and post-operative liver volumes(Baseline, week 1, week 3 then every 2 weeks until surgery or week 7 and 4 weeks after surgery)