MRCP Diagnoses EHCC Better When Combined DWI

NCT ID: NCT01595217

Last Updated: 2017-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-05-31

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.

Conditions

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Biliary Tract Neoplasm Cholangiocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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MRCP and DWI using 3T MRI

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

Group Type EXPERIMENTAL

3T MRI

Intervention Type DEVICE

diffusion weighted imaging(DWI) of biliary tract with GE Signa 3-tesla device

MRCP only using 3T MRI

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

Group Type EXPERIMENTAL

3T MRI

Intervention Type DEVICE

diffusion weighted imaging(DWI) of biliary tract with GE Signa 3-tesla device

Interventions

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3T MRI

diffusion weighted imaging(DWI) of biliary tract with GE Signa 3-tesla device

Intervention Type DEVICE

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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Hospital of China Medical University

OTHER

Sponsor Role collaborator

China Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Xiaoping Yang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaoping yang, MD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of China Medical University

Locations

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Room of 3.0TMR in the FAH of CMU

Shenyang, Liaoning, China

Site Status

Countries

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China

Other Identifiers

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XYang

Identifier Type: -

Identifier Source: org_study_id

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