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临床试验/NCT03213314
NCT03213314已完成不适用

HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies

University of Edinburgh2 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2017年9月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
149
试验地点
2
主要终点
Correlation between the pre-operative liver health assessment score and the post-operative liver function composite integer-based risk score.

研究概览

简要总结

This observational clinical cohort study aims to evaluate the clinical utility of LiverMultiScan in quantifying liver health prior to liver resection or TACE. The results will enable further developments in scanning protocols and software, and clearly define the relevance of applying this technology as part of the pre-operative assessment of the patient being considered for liver resection or TACE.

详细描述

The liver is unique among the abdominal organs for the capacity to regenerate post-operatively. However, a minimum functional liver remnant (FLR) is required for patients to survive the initial perioperative period. At present, the assessment of the FLR is based on volume alone, in the context of clinical judgment and surrogate markers of liver function based on blood tests. Recently, Perspectum Diagnostics have developed and validated LiverMultiScan, an MRI-based technology that can non-invasively quantify fibroinflammatory disease in addition to steatosis and iron content. In this project, we plan to use LiverMultiScan as an additional direct measurement of liver health prior to resectional surgery or transarterial chemoembolization (TACE), so that liver volume and function can be combined. For example, surgery with a predicted FLR of 21% might be survivable if the liver tissue was in extremely good health, whereas surgery with a predicted FLR of 40% might be lethal if the liver tissue was in poor health. Occasionally, portal vein embolization (PVE) is performed to promote hypertrophy of the FLR. Furthermore, non-resectional intervention, for example TACE for primary liver cancers, is well-tolerated by patients with healthy livers, but can lead to serious liver decompensation and liver failure if TACE is delivered to a liver in poor health. Currently, the available imaging modalities are limited in their ability to assess liver health in liver resection or TACE candidates. Liver fat content (steatosis) can be assessed with CT, or more accurately with MRI. However, fibroinflammatory disease, which has been shown to correlate with post-resection morbidity, typically requires an invasive biopsy to diagnose accurately.

This research project will support the definition, development and technical validation of Hepatica, which aims to build on the MRI technology underlying LiverMultiScan and develop the additional functionality required to meet this clinical need.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
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

  • •Patients being considered for liver resection

排除标准

  • •i. Patients under the age of 18 years will be excluded from the present study. ii. Prisoners will be excluded from the present study. iii. Persons unable to have an MRI scan (including but not limited to claustrophobia, implanted metallic devices, metal foreign body) iv. Adults with incapacity v. Non-provision of consent

研究组 & 干预措施

Main cohort

Experimental

Patients undergoing liver resection

干预措施: Multiparameter magnetic resonance imaging (Diagnostic Test)

Nested cohort PVE

Experimental

Patients undergoing liver resection after portal vein embolisation

干预措施: Multiparameter magnetic resonance imaging (Diagnostic Test)

Nested cohort neoadjuvant chemotherapy

Experimental

Patients undergoing liver resection after neoadjuvant chemotherapy

干预措施: Multiparameter magnetic resonance imaging (Diagnostic Test)

Nested cohort TACE

Experimental

Patients undergoing trans arterial chemoembolisation for presumed hepatocellular carcinoma

干预措施: Multiparameter magnetic resonance imaging (Diagnostic Test)

结局指标

主要结局

Correlation between the pre-operative liver health assessment score and the post-operative liver function composite integer-based risk score.

时间窗: 24 months

Correlation between the pre-operative liver health assessment score (Hepatica score - calculated by weighting future remnant liver volume by liver inflammation and fibrosis (LIF) score) and the post-operative liver function composite integer-based risk (Hyder-Pawlik) score.

次要结局

  • To compare LiverMultiScan image interpretations with histological findings(24 months)
  • • To evaluate LiverMultiScan image interpretations correlated with post-operative length of stay.(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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