Diagnostic accuracy of MRI for gallbladder polyps; a prospective diagnostic pilot study

Completed

• Conditions: gallbladder polyp; polypoid lesion of the gallbladder; 10017628

• Registration Number: NL-OMON42653
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Having proven GB polyp(s) (bij ultrasound or other imaging modality)
Being considered to undergo cholecystectomy
Aged 18 years or older
Providing informed consent

Exclusion Criteria

Being pregnant
Having renal dysfunction (>=CKD 3)
Being unable to undergo MRI due to any reason (e.g claustrophobic, non MRI-compatible implants)
Known allergy or prior reaction to gadolinium-based contrast agent
Insufficient control of the Dutch language to understand the patient information/fill-out questionnaire
Unable to provide informed consent

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Test characteristics (sensitivity, specificity, predictive values, accuracy and<br /><br>number needed to treat (NNT)) of MRI (compared to histopathological analysis of<br /><br>the gallbladder) for the (differential) diagnosis of GB polyps and<br /><br>differentiation between true and pseudo polyps</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Difference in test characteristics between MRI and TAUS for the (differential)<br /><br>diagnosis of GB polyps and the differentiation between true and pseudo polyps.</p><br>