Multicentric Prospective Study Assessing the Efficiency of Preoperative Reversible Selective Portal Vein Embolization in Patients Requiring Major Hepatic Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Hypertrophy ratio of FLR volume / total liver volume between the baseline and after the PVE
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Single-arm feasibility study
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
Hypertrophy ratio of FLR volume / total liver volume between the baseline and after the PVE
时间窗: 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
次要结局
- Technical feasibility: Percentage of completed PVE(During the procedure of portal vein embolization)
- Technical feasibility: Percentage of partially completed PVE(During the procedure of portal vein embolization)
- Rate of patients that finally undergo surgery(Through study completion, an average of 14 months)
- Per and post procedure (within 6 weeks) morbidity(During PVE and within 6 weeks after embolization)
- Intraoperative morbidity.(Up to 90 days following liver surgery.)
- Technical feasibility: Percentage of not performed PVE(During the procedure of portal vein embolization)
- Liver tolerance(At Day0, Day1 and Day7 after portal vein embolization)
- Rate of portal partial and complete recanalization (subsegmental, segmental and sectorial)(4-6 weeks after portal vein embolization)
- Rate of patients considered after portal vein embolization for surgery in their centers(Through study completion, an average of 14 months)
- Inflammation and adhesions during portal pedicles dissection(During liver surgery.)