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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42653

Enrollment

Registered

2016-03-09

Start date

2016-05-20

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gallbladder polyp polypoid lesion of the gallbladder

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Test characteristics (sensitivity, specificity, predictive values, accuracy and number needed to treat (NNT)) of MRI (compared to histopathological analysis of the gallbladder) for the (differential) diagnosis of GB polyps and differentiation between true and pseudo polyps	—

Secondary

Measure	Time frame
Difference in test characteristics between MRI and TAUS for the (differential) diagnosis of GB polyps and the differentiation between true and pseudo polyps.	—

Countries

Netherlands

Outcome results