Comparison of a full-core end-cut biopsy device with a side-notch device: diagnostic valence of the specimen

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00012565

Enrollment

Registered

2017-06-22

Start date

2017-07-05

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

OPS-Code 1-441.0: Percutaneous biopsy of the liver

Interventions

Group 1: Full-Core-Biopsy System Group 2: Side-Notch-Biopsy System

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Biopsy cylinder length and diameter, presence of crush artefacts, number of portal fields in the biopsy of non-tumor liver tissue.	—

Countries

Germany

Contacts

Public ContactStefanie Hagn

Universitätsklinikum Regensburg

stefanie.hagn@ukr.de0941 9447410

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026