Non-invasive Rapid Assessment of Patients With Liver Transplants Using Magnetic Resonance Imaging With LiverMultiScan.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Perspectum
- 入组人数
- 131
- 试验地点
- 3
- 主要终点
- The cT1 (inflammation) measured by LMS compared to biopsy results, to assess fibro-inflammatory status and rejection status
研究概览
简要总结
This will be a prospective, multi-centre, biomarker trial comparing the accuracy of a new test (LiverMultiScan) against an existing test (liver biopsy) in the assessment of liver transplant recipients, designed in accordance with the STARD criteria.
Study participants are 200 patients with liver transplant, due to undergo liver biopsy as part of serial evaluation of their liver health and to rule out rejection. The whole study will take 3 years with 2 years of recruitment The main aim is to investigate whether the introduction of LiverMultiScan as a standardised diagnostic test for liver disease can match the diagnostic yield of existing biopsies.
详细描述
Long-term survival after solid organ transplantation has increased during the last decade due to improvements in surgical technique, peri-operative care, and more efficient immunosuppression (IS) (1). However, transplant recipients still exhibit higher morbidity and mortality than the general population. One of the main causes are co-morbidities which are negatively influenced by chronic IS drug usage. It is however a very fine balance, as under-usage of IS can lead to transplant rejection (2). Therefore, many paediatric and some adult liver transplant recipients have regular liver biopsies as part of their serial evaluation, so-called 'routine liver biopsies'. Biopsy is performed if there is suspected rejection, as no current non-invasive tests are both sensitive and specific for rejection. Biopsy is used to identify early histological signs of rejection. However, there are some problems;
- There is a risk of complication due to biopsy(1 in 10,000)
- biopsies are painful
- sample only a tiny fraction of the liver and for children there is a need to sedate.
Therefore, they are less-than-perfect for serial evaluation. Optimisation of IS has become a priority goal in transplantation, but is hampered by the lack of diagnostic tests available for serial monitoring (3). There are potential benefits of IS minimization or withdrawal, however this need to be balanced with the risks, inconveniences and costs of prompting liver allograft rejection.
Identification of a reproducible and reliable non-invasive assessment tool for the transplanted liver, such as multiparametric quantitative MRI, would therefore substantially benefit the liver transplant population. In Europe, approximately 6000 liver transplants are performed every year (1). Under the current standard-of-care, indefinite pharmacological IS is prescribed to all of them. The cost of immunosuppressive drugs is €4200- €7000 per patient per year (£3000-£5000/patient/year). In addition to its cost, chronic IS may result in substantial side effects (hypertension, diabetes, renal insufficiency, hyperlipidaemia, cancer, infections) that contribute to patient morbidity and mortality (2). Rejection is a major concern with liver transplant recipients. At present, there is no clear non-invasive diagnostic pathway to identify early rejection. We would like to see if the implementation of LiverMultiScan (4) to monitor the transplant population and modify treatment can replace or equal the yield of invasive liver biopsies in the post-transplant population.
Therefore, the aim of this study is to determine whether there is concordance between using LiverMultiScan and liver biopsy in a post-liver transplant population.
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
- 6 Years 至 75 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 6 yrs old with a liver transplant.
- •Patients due to undergo routine liver biopsy or biopsy for suspected pathology after liver transplantation
- •Patients (and / or Guardians) who are willing and able to give informed consent for participation in the study.
排除标准
- •The participant may not enter the study if they have any contraindication to magnetic resonance imaging (inc pregnancy, pacemaker, shrapnel injury, severe claustrophobia). We will record the number of patients who have to be excluded for those reasons (expected to be <5%).
- •Children / adults with a contraindication to liver biopsy (coagulopathy, obstructed biliary tract with high risk of bile leak, ascites etc).
- •Children or adults who are unable to tolerate MRI without sedation or general anaesthetic.
结局指标
主要结局
The cT1 (inflammation) measured by LMS compared to biopsy results, to assess fibro-inflammatory status and rejection status
时间窗: 12 months
To investigate whether the introduction of LiverMultiScan as a standardised diagnostic test for liver disease can match the diagnostic yield of existing biopsies.
次要结局
- Patient feedback on LiverMultiScan(1 Year)
- LiverMultiScan utility(1 year)
- Correlation of diagnostic tests.(1 Year)
- Biliary changes using MRCP.(1 Year)
