Hepatectomy Risk Assessment With Functional Magnetic Resonance Imaging
试验速览
- 阶段
- 不适用
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Correlation coefficient between preoperative FLR-GC and post-operative ICG R15
研究概览
简要总结
Liver resection remains the only curative option for primary or metastatic liver cancer, but a more accurate prediction of post-hepatectomy liver failure (PHLF) is needed to further reduce morbidity and mortality and to extend the indication to a wider patient population. Magnetic resonance Imaging (MRI) is a promising new source of liver function tests as it can provide segmental function alongside measurements of perfusion, tissue structure and standard morphological assessment.
The primary aim of HEPARIM is to determine if quantitative MRI biomarkers of liver function and perfusion can improve predictions of post-hepatectomy liver function, as measured by an indocyanine green (ICG) liver function test. Secondary aims is to validate the MRI measurements of liver function against ICG.
HEPARIM is an observational cohort study recruiting patients referred locally for a one- or two-stage liver resection of 2 segments or more. Before surgery, all participants will undergo an ICG liver function test and a Dynamic Gadoxetate-enhanced (DGE) MRI scan of the liver. The ICG test will be repeated at one day after surgery. The Gadoxetate Clearance (GC) of the future liver remnant (FLR-GC) will be determined from the DGE-MRI data and correlated to the post-operative ICG R15 as primary outcome measure. Preoperative ICG R15 will be correlated against GC of the whole liver (WL-GC) to address the secondary objective. In patients that undergo a staged hepatectomy, an additional MRI and ICG test will be performed before the first stage to assess its effect on volumetric and functional growth of the FLR.
Additional pre- and postoperative data will be collected from medical records including demographics and medical histories, biochemistry, pathology and radiology reports, and any long-term outcome data collected in the 90-day follow-up visit. These data will be used in a multi-variate analysis to determine which preoperative biomarkers are most predictive of immediate and long-term outcomes, to identify the added value of functional MRI over routine clinical markers, and to derive a multi-variate prediction model that can be validated in future studies.
详细描述
OBJECTIVES
(1) To determine if DGE-MRI can improve predictions of post-hepatectomy liver function; (2) To validate DGE-MRI based measurements of liver function against gold-standard liver function tests; (3a) to determine if preoperative DGE-MRI can improve predictions of post-operative PHLF; (3b) to develop a multi-parametric prediction model for 90-day post-operative outcome combining MRI, clinical chemistry and patient history; (3c) To determine the relationship between volumetric and functional liver growth after portal vein embolisation.
RECRUITMENT
Patients considered for major liver resection will be identified at the Hepatobiliary multi-disciplinary team (MDT) meeting at St James University Hospital Leeds, and contacted by phone. Patients will have at least 3 days to consider this information, and after that they will be contacted by the member of their clinical care team to schedule the baseline visit. Formal written consent will be obtained on the day of the visit. If they don't consent to participation, then only the MRI scans will be collected and stored in their medical records.
BASELINE VISIT
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
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over 18 years of age and under 80 years
- •Referred to the hepatobiliary surgical service at St James's Hospital
- •Diagnosed with any hepatic tumour
- •i) Referred for liver resection (defined as two or more Couinaud segments) by multi-disciplinary team discussion at Saint James's Hospital (One stage arm) ii) OR Referred for PVE or ALPPS prior to likely major hepatectomy by multi-disciplinary team discussion at Saint James's Hospital (Two stage arm)
排除标准
- •Unable to consent independently
- •Previous liver resection
- •Private patients
- •Concurrent malignancy unrelated to liver tumour
- •Chronic renal failure (estimated Glomerular Filtration Rate < 30 mL/min)
- •Possible pregnancy
- •Other contraindications to DGE-MRI, including:
- •i) Cochlear Implant ii) Aneurysm Clips iii) Neurological stimulator iv) Implanted cardiac devices v) Metal heart valve vi) History of metal foreign bodies in orbits vii) Other implanted metal device which prevents MRI viii) Known allergy to Gadolinium contrast ix) Claustrophobia x) Weight exceeding 250 kg xi) Maximal diameter exceeding 55cm
- •Other contraindications to ICG i) Known allergy to Indocyanine green ii) Known allergy to sodium iodine iii) Known reaction or allergy to iodine iv) Previous diagnosis of a thyroid problem v) Breastfeeding
结局指标
主要结局
Correlation coefficient between preoperative FLR-GC and post-operative ICG R15
时间窗: End of 2 year recruitment
Correlation between preoperative estimates of liver function using gadoxetate clearance of the FLR (FLR-GC) derived from MRI data and post-operative measurement of liver function using ICG clearance
次要结局
- Correlation coefficient between preoperative WL-GC and pre-operative ICG R15(End of 2 year recruitment)
- Correlation coefficient between growth in FLR volume and growth in FLR-GC after the first stage(End of 2 year recruitment)
研究者
Steven Sourbron
Professor
University of Leeds