The Incremental Value of 3T Diffusion-Weighted MRI in Diagnosing Extrahepatic Cholangiocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- EHCC performance on DWI, ADC map and MRCP
研究概览
简要总结
Researching the diagnostic significance of Biliary Tract Neoplasm under combining DWI sequence with MRCP versus MRCP only separately.
详细描述
The purpose of the study is to evaluate the usefulness of diffusion weighted imaging(DWI) combined with MRCP of 3.0T magnetic resonance imaging (MRI) in the evaluation of suspected malignant bile duct diseases. People with suspected Biliary Tract Neoplasm based on clinical symptoms (such as jaundice and thinness with unknown reasons) and CA-199 value raises are included.Diagnosis divided into two steps: the first one，only provide conventional MR sequences and MRCP images to make a diagnosis; the second step,provide the DWI images additionally, combining the image data before to make a diagnosis. Hypothesis is that DWI sequence should be regularly added into MRCP examination for improving diagnosis rate of Biliary Tract Neoplasm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Two experienced professors of radiology observed and analyzed the images separately. They were not involved in image acquisition and were blinded to the patients' clinical, surgical and histological information. Conventional MR sequences were qualitatively analyzed in the first reading session, including T2WI, FIESTA, 2D MRCP and 3D MRCP sequences, and after one week, DWI under three different b values with ADC map combined with the preceding conventional sequences were analyzed respectively as the second reading session.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Suspected Biliary Tract Neoplasm based on clinical symptoms(such as jaundice and thinness with unknown reasons)and CA-199 raises（>37U/mL）
- •No evidence of clinical symptoms or CA-199 increase by non-bile duct cancerous factors(hepatitis,cholangeitis,stones)
排除标准
- •Previous Biliary Tract Neoplasm surgery
- •Contraindication for MRI (such as pacemaker or inner ear implant)
- •Claustrophobia
- •Age < 16
结局指标
主要结局
EHCC performance on DWI, ADC map and MRCP
时间窗: at the end of the study
Two experienced professors of radiology observed and analyzed the images separately. If there were discrepancies, the two professors came to an agreement by consensus.
次要结局
- ADC, SNR, CNR and SIR for EHCC lesion under different b values(at the end of the study)
研究者
Xiaoping Yang
Principal Investigator
China Medical University, China