SMI and CEUS in the Diagnosis of Benign Focal Liver Lesions: Comparison of Diagnostic Accuracy Considering Examiner Experience

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00040918

Enrollment

Registered

2026-07-17

Start date

2026-08-03

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

D18.03 D13.4 K76.8

Interventions

Group 1: Analysis of the impact of examiner experience on the diagnostic accuracy of two ultrasound modalities for the diagnosis of benign focal liver lesions based on retrospectively collected patien

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: -Patients with an ultrasonographically visualized benign liver lesion -Gastroenterology colleagues with basic or advanced understanding of contrast-enhanced ultrasound (CEUS) -Medical students at Heinrich Heine University who have completed their second year of study and successfully participated in the faculty-internal elective course "Basic Abdominal Ultrasound"

Exclusion criteria

Exclusion criteria: -Gastroenterology colleagues without prior experience in contrast-enhanced ultrasound (CEUS). -Students who have not completed their second year of study and/or have not successfully completed the elective course "Basic Abdominal Ultrasound".

Design outcomes

Primary

Measure	Time frame
- Determination of diagnostic accuracy in identifying benign focal liver lesions via ultrasound sequences, calculated as the proportion of correctly identified entities in the multiple-choice questionnaire. -Determination of learning progress, defined as the difference in correctly diagnosed entities for each ultrasound modality between baseline and post-teaching levels.	—

Secondary

Measure	Time frame
-Diagnostic performance: Determination of sensitivity and specificity for each of the three entities depending on the ultrasound modality used. -Subjective confidence: Assessment of the confidence score via a Likert scale after each diagnostic stage, as well as evaluation of a potential correlation between the confidence score and the actual accuracy of the diagnosis. -Inter-reader agreement: Determination of the degree of agreement within and between the reader groups using Kappa. -Comparison of learnability: Determination of the difference in knowledge gain among students between the SMI and CEUS groups.	—

Measure

Time frame

-Diagnostic performance: Determination of sensitivity and specificity for each of the three entities depending on the ultrasound modality used. -Subjective confidence: Assessment of the confidence score via a Likert scale after each diagnostic stage, as well as evaluation of a potential correlation between the confidence score and the actual accuracy of the diagnosis. -Inter-reader agreement: Determination of the degree of agreement within and between the reader groups using Kappa. -Comparison of learnability: Determination of the difference in knowledge gain among students between the SMI and CEUS groups.

—

Countries

Germany

Contacts

Public ContactMichael Kallenbach

Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie

michael.kallenbach@med.uni-duesseldorf.de0211/ 81-16866

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026