MRCP Diagnoses EHCC Better When Combined DWI

China Medical University, China

Status: Completed

Conditions: Biliary Tract Neoplasm; Cholangiocarcinoma

Treatments: Device: 3T MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT01595217

XYang

Details and patient eligibility

About

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

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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99 participants in 2 patient groups

MRCP and DWI using 3T MRI

Experimental group

Description:

MRCP and DWI using Magnetic resonance imaging（GE Signa,3.0 T )

Treatment:

Device: 3T MRI

MRCP only using 3T MRI

Experimental group

Description:

MRCP only using Magnetic resonance imaging（GE Signa,3.0 T )

Treatment:

Device: 3T MRI