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临床试验/NCT06181318
NCT06181318尚未招募不适用

Predicting the Outcomes of LIVEr Resection Using Quantitative Magnetic Resonance Imaging: the POLIVER Study

University Hospital Heidelberg0 个研究点目标入组 33 人开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
33
主要终点
Predicting the posthepatectomy biliary leakage after major liver resection

研究概览

简要总结

The present observational study aims to assess the benefit of this quantitative multiparametric magnetic resonance imaging (MRI) in clinical practice, to quantify future liver remnant performance, and to accurately predict the risk of liver failure after major hepatectomy, among patients undergoing major liver resection.

The main questions to be answered are:

  • Can multiparametric MRI predict the postoperative liver function?
  • Can multiparametric MRI predict the postoperative liver-specific complications as well as mortality? With ethical approval and fully informed consent, patients being considered for major liver resection will undergo clinical assessment, blood sampling, and multiparametric MRI before surgery. For the primary outcome, 33 participants will be needed to detect a minimum correlation coefficient of 0.2 with 5% significance and 80% power.

详细描述

In patients being considered for major liver resection, volumetric and functional evaluation of the future liver remnant should ideally be combined to reduce the risk of posthepatectomy liver failure (PHLF) and other adverse outcomes. Quantitative multiparametric magnetic resonance imaging (MRI) can measure liver health by assessing parenchyma fibrosis and inflammation. This has shown promising results in predicting postoperative liver performance. The current study aims to assess the benefit of this MRI-based technology in clinical practice, to quantify future liver remnant performance, and to accurately predict the risk of liver failure after major hepatectomy.

Prospective observational clinical study in a single hepatobiliary surgery center. With ethical approval and fully informed consent, patients being considered for major liver resection will undergo clinical assessment, blood sampling, and multiparametric MRI before surgery. Postoperative liver function and complications will be reported for 90 days after surgery. Preoperative MRI assessment scores and postoperative outcomes will be correlated to determine whether multiparametric MRI scans can accurately predict the risk of postoperative liver-specific complications (primary endpoint) as well as postoperative liver function, surgery-specific complications, the overall complication rate, quality of hospital care, and length of stay. For the primary outcome, 33 participants will be needed to detect a minimum correlation coefficient of 0.2 with 5% significance and 80% power. This study will include 33 patients and results are expected in 2024. If successful, this investigation will support the use of quantitative multiparametric MRI to guide surgical decision-making. This will represent a non-invasive, diagnostic, volumetric, and segmental functional test for the preoperative workup of patients being considered for major hepatectomy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (≥ 18 years old) patients with an indication for elective major liver resection.
  • Any benign or malignant indication.
  • Provision of informed consent.
  • MRI scan performed ≤ 7 days before surgery

排除标准

  • Previous liver resection.
  • Previous volume-enhancing procedures, such as portal vein embolization.
  • Previous microwave ablation of liver lesions.
  • Contraindication and/or inability to undergo contrast-enhanced MRI scan (including implanted metallic devices or foreign bodies, claustrophobia and contraindication for Primovist® administration).

结局指标

主要结局

Predicting the posthepatectomy biliary leakage after major liver resection

时间窗: 90 days postoperative

Correlation between future liver remnant performance (combined measure of liver volume, PDFF, and cT1) and posthepatectomy biliary leakage after major liver resection

Predicting the posthepatectomy liver failure after major liver resection

时间窗: 90 days postoperative

Correlation between future liver remnant performance (combined measure of liver volume, PDFF, and cT1) and posthepatectomy liver failure after major liver resection

Predicting the posthepatectomy hemorrhage after major liver resection

时间窗: 90 days postoperative

Correlation between future liver remnant performance (combined measure of liver volume, PDFF, and cT1) and posthepatectomy hemorrhage after major liver resection

次要结局

  • Correlation between remnant liver function after major liver resection and incidence of major complications(90 days postoperative)
  • Correlation between remnant liver function after major liver resection and postoperative mortality(90 days postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arianeb Mehrabi, MD

Professor Dr. med.

Fundacao Champalimaud

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Quantitative MRI and Outcomes of Liver Resection | 临床试验