Brief Title
MRCP Diagnoses EHCC Better When Combined DWI
Official Title
The Incremental Value of 3T Diffusion-Weighted MRI in Diagnosing Extrahepatic Cholangiocarcinoma
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.
Study Type
Interventional
Primary Outcome
EHCC performance on DWI, ADC map and MRCP
Secondary Outcome
ADC, SNR, CNR and SIR for EHCC lesion under different b values
Condition
Biliary Tract Neoplasm
Intervention
3T MRI
Study Arms / Comparison Groups
MRCP and DWI using 3T MRI
Description: MRCP and DWI using Magnetic resonance imaging（GE Signa,3.0 T )
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
99
Start Date
March 2012
Completion Date
May 2013
Primary Completion Date
March 2013
Eligibility Criteria
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
Gender
All
Ages
16 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Xiaoping yang, MD, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT01595217
Organization ID
XYang
Responsible Party
Principal Investigator
Study Sponsor
China Medical University, China
Collaborators
First Hospital of China Medical University
Study Sponsor
Xiaoping yang, MD, Principal Investigator, First affiliated Hospital of China medical university
Verification Date
May 2017