MRCP Diagnoses EHCC Better When Combined DWI

Not Applicable

Completed

• Conditions: Biliary Tract Neoplasm; Cholangiocarcinoma
• Interventions: Device: 3T MRI

• Registration Number: NCT01595217
• Lead Sponsor: China Medical University, China

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 Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-05-08
• Study First Submitted QC: 2012-05-08
• Study First Posted: 2012-05-09
• Primary Completion: 2013-03
• Study Completion: 2013-05
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-14
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MRCP only using 3T MRI	3T MRI	MRCP only using Magnetic resonance imaging（GE Signa,3.0 T )
MRCP and DWI using 3T MRI	3T MRI	MRCP and DWI using Magnetic resonance imaging（GE Signa,3.0 T )

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Room of 3.0TMR in the FAH of CMU; 🇨🇳 Shenyang, Liaoning, China