Biliary Tract Neoplasm, Cholangiocarcinoma
Conditions
Keywords
Biliary Tract Neoplasm, Cholangiocarcinoma, Diffusion magnetic resonance imaging, Magnetic resonance imaging, Magnetic resonance Cholangiopancreatography
Brief summary
Researching the diagnostic significance of Biliary Tract Neoplasm under combining DWI sequence with MRCP versus MRCP only separately.
Detailed description
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.
Interventions
DEVICE3T MRI
diffusion weighted imaging(DWI) of biliary tract with GE Signa 3-tesla device
Sponsors
First Hospital of China Medical University
China Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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) * Age ≥ 16
Exclusion criteria
* Previous Biliary Tract Neoplasm surgery * Contraindication for MRI (such as pacemaker or inner ear implant) * Claustrophobia * Age \< 16
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EHCC performance on DWI, ADC map and MRCP | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ADC, SNR, CNR and SIR for EHCC lesion under different b values | at the end of the study | The ADC value of EHCC in DWI under various b values was measured, and the SNR, the CNR and the SIR in DWI were calculated. The formula for calculating the ADC value was: ADC = \[ln (S1 /S2)\]/ (b2 -b1) , (S and b represent signal intensity and b value, 1 and 2 represent low and high, respectively). |
Countries
China
Outcome results
None listed