MRCP Diagnoses EHCC Better When Combined DWI

Study Overview
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Brief Summary
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Researching the diagnostic significance of Biliary Tract Neoplasm under combining DWI sequence with MRCP versus MRCP only separately.

Detailed Description
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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.

Official Title
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The Incremental Value of 3T Diffusion-Weighted MRI in Diagnosing Extrahepatic Cholangiocarcinoma

Conditions
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Biliary Tract Neoplasm, Cholangiocarcinoma

Intervention / Treatment
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* Device: 3T MRI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRCP and DWI using 3T MRI<br>MRCP and DWI using Magnetic resonance imaging（GE Signa,3.0 T ) | Device: 3T MRI<br>* diffusion weighted imaging(DWI) of biliary tract with GE Signa 3-tesla device<br>|
| Experimental: MRCP only using 3T MRI<br>MRCP only using Magnetic resonance imaging（GE Signa,3.0 T ) | Device: 3T MRI<br>* diffusion weighted imaging(DWI) of biliary tract with GE Signa 3-tesla device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EHCC performance on DWI, ADC map and MRCP | Two experienced professors of radiology observed and analyzed the images separately. If there were discrepancies, the two professors came to an agreement by consensus. | at the end of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADC, SNR, CNR and SIR for EHCC lesion under different b values | 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). | at the end of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biliary Tract Neoplasm, Cholangiocarcinoma, Diffusion magnetic resonance imaging, Magnetic resonance imaging, Magnetic resonance Cholangiopancreatography