Comparison of a full-core end-cut biopsy device with a side-notch device: diagnostic valence of the specime
Not Applicable
- Conditions
- OPS-Code 1-441.0: Percutaneous biopsy of the liver
- Registration Number
- DRKS00012565
- Lead Sponsor
- niversitätsklinikum Regensburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Patients undergoing clinically indicated biopsy of unclear liver lesions. Male patients and non-pregnant, non-lactating females aged =18 years of age, INR>1.4, thrombocyte count >10×109/l, informed consent signed.
Exclusion Criteria
Any condition which, in the judgment of the clinical investigator or his designee, might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study. A mental condition rendering the patient unable to provide informed consent.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint is diagnostic valence of the specimen; i.e. if the specimen is sufficient to establish a diagnosis. This is rated by two independent pathologists unaware of the device used.
- Secondary Outcome Measures
Name Time Method Biopsy cylinder length and diameter, presence of crush artefacts, number of portal fields in the biopsy of non-tumor liver tissue.