The Correlation Between MRCP and Biopsy Pre-LDLT for Liver Steatosis Assessment: an Ambidirectional Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Liver steatosis
研究概览
简要总结
There is a major shortage of donor livers in the Netherlands. Living donor liver transplantation (LDLT) is a good solution to this shortage. Donor screening is extensive to minimalize risks for donors and recipients. During screening, the vascular anatomy of the liver is assessed with CT, the bile duct anatomy with MRCP, and liver steatosis with a biopsy. Biopsy is an invasive intervention with some risk of complications. MRCP can aid in steatosis assessment. Previous research suggested that biopsy can be performed on indication. However, the sensitivity of detecting different steatosis percentages on MRCP varies widely, which makes determining the degree of steatosis difficult and less reliable. This project investigates whether MRCP is equally adequate as biopsy in assessing liver steatosis. It may lead to a faster, less burdensome and minimal invasive screening process.
详细描述
Research methods:
General and biopsy data (liver steatosis percentage) and MRCP images will be extracted from HiX. Screenshots of the images will be made. All personal data will be blacked out using Microsoft Powerpoint 16.90.2. The MRCP-images and biopsy data will be coded at random with different codes for the MRCP and biopsy of the same donor. The coded images will be shared with the radiologist through Castor. He will assess liver steatosis on MRCP. He will register his findings in Castor and share this file with the study coordinator.
Analysis:
Normality will be tested using the Shapiro-Wilk test. Homogeneity of variances will be tested using the F-test. A QQ-plot will be used to check for outliers. For the baseline donor characteristics, sex differences will be investigated for age, weight, height, and BMI using the unpaired samples t-test or Mann-Whitney test.
Similarities and differences between liver steatosis assessment on MRCP and biopsy will be thoroughly described.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Living liver donation between May 2004 and June 2026 at the Erasmus MC
- •Written informed consent
排除标准
- •- There are no exclusion criteria for this study.
结局指标
主要结局
Liver steatosis
时间窗: Preoperative during screening for living liver donation.
The primary outcome is the percentage of liver steatosis.
次要结局
未报告次要终点
研究者
Robert Minnee
Hepato-Pancreato-Biliary/Transplant Surgeon, PhD
Erasmus Medical Center