Haemodynamic Modeling of Intrahepatic Blood Flow and Interaction With the Systemic Circulation
试验速览
- 阶段
- 不适用
- 入组人数
- 55
- 主要终点
- Estimation of the intraoperative portocaval post-hepatectomy gradient This pressure differential is performed before the parietal closure, after resection. We consider that the simulation is accurate if the difference with the measurement is ≤ 4 mmHg.
研究概览
简要总结
Despite the medical and surgical progress of the last two decades, the selection of candidates for liver surgery remains based on old principles and insufficiently sensitive to fine-tune the gesture to patient-specific characteristics and make almost zero risks of postoperative liver failure (PLF) and death. It is therefore necessary to develop new tools that will make possible to predict the evolution of the postoperative portocaval gradient (difference of pressure between portal vein and vena cava), a well-known major risk factor for PLF. Hemodynamic modeling of the human liver during surgery will represent the purpose of this work in order to help the clinicians in their patient's selection and anticipation of postoperative risk.
详细描述
Introduction:
Surgical management of liver cancers is increasingly complex, with often extensive and iterative resections on pathological liver. This attitude is made possible by good selection and perioperative management of patients, as well as the regenerative capacity of the liver. However, even if extensive resections are routinely performed, the limit remains the risk of postoperative liver failure (PLF), especially in patients with chronic liver disease. Despite many known risk factors, some of which being preventable, PLF and / or postoperative decompensation (ascites) remain common complications (incidence > 5%) and PLF is one of the leading causes of postoperative death.
The difficulty lies in the choice of a treatment adapted to the oncological needs, with the balance between what is technically feasible and what will be functionally and metabolically tolerated. This balance is based on a surgical evaluation, based on objective factors (liver volumetry and biological tests for example) and on the surgeon's experience. This estimate is imperfect, the proof being the mortality at 3 months after hepatectomy which remains high, 5 to 7%. Moreover, the current criteria lead to an often-inappropriate selection. It therefore remains very difficult for a given patient (particularly cirrhotic) to accurately predict the risk of postoperative decompensation and some patients may sometimes be undertreated for fear of decompensation. In these patients, it is therefore a loss of chance.
It would be obviously possible to further improve these results and numerical tools must find their place in the medico-surgical algorithm. The investigators think that hemodynamic simulation could be used as a decision-making tool.
After hepatectomy, the post-resection portocaval gradient is one of the most relevant reflections for understanding the hemodynamic conditions of a liver and the risk of PLF but it is only available intraoperatively, after completion of the surgical procedure, and is therefore not used as a tool for selecting candidates for surgery. Moreover, for a given patient, it is not currently possible to anticipate the variation of portocaval gradient and therefore the risk of occurrence of PLF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Adults ≥18 years old informed and consenting.
- •Partial hepatectomy by laparotomy (open approach).
- •Access to intraoperative measurements of vascular pressures and flow rates.
- •Major patients (age≥18 years)
- •Hepatic pathology requiring minor or major hepatectomy by laparotomy
- •Affiliation to a social security scheme
- •Written consent to participate in this research
排除标准
- •Pregnant or breastfeeding women,
- •Patient under guardianship or curatorship
- •Refusal to participate in the study
- •Contraindication to performing MRI.
- •Patient already included in an interventional study
研究组 & 干预措施
only one arm (resected patients)
liver resection group
干预措施: partial hepatectomy by laparotomy on healthy or pathologic parenchyma. (Procedure)
结局指标
主要结局
Estimation of the intraoperative portocaval post-hepatectomy gradient This pressure differential is performed before the parietal closure, after resection. We consider that the simulation is accurate if the difference with the measurement is ≤ 4 mmHg.
时间窗: prtocaval gradient (difference between portal pressure and caval pressure assessend during surgery.
次要结局
- Prediction of changes in cardiac output, hepatic artery and portal vein after hepatectomy.(Measures perormed during surgery)
- Prediction of changes in portal vein flow(Measures perormed during surgery)
- Prediction of changes in hepatic artery flow(Measures perormed during surgery)