Differences in ultrasound-measured liver and spleen stiffness between two established methods – ELastography of VISceral organs (Liver & Spleen)

Differences in ultrasound-measured liver and spleen stiffness between two established methods – ELastography of VISceral organs (Liver & Spleen) - ELVIS-Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00040024

Enrollment

Registered

2026-05-15

Start date

2026-05-18

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Q20.1 Q23.4 Q22.4 Q20.1 Q20.8 Q20.9 Q22.6

Interventions

Group 1: Patients with Fontan circulation undergo a one-time assessment of liver and spleen stiffness using transient elastography (TE) and two-dimensional shear-wave elastography (2D SWE) Group 2: Co

Eligibility

Sex/Gender

All

Age

18 Years to 25 Years

Inclusion criteria

Inclusion criteria: Healthy

Exclusion criteria

Exclusion criteria: any known liver disease (e.g., hepatic fibrosis, liver cirrhosis, infectious liver diseases, or liver tumors), other vascular conditions (including elevated central venous pressure), cardiovascular diseases (e.g., arrhythmias, hypertension, heart failure), metabolic disorders (e.g., hyperthyroidism, disorders of glucose metabolism), gastrointestinal diseases (e.g., gallbladder disease, gallstones, biliary obstruction), renal disease, neurological or psychiatric disorders, acute or chronic infections including Epstein-Barr virus (EBV), cytomegalovirus (CMV), and human immunodeficiency virus (HIV), autoimmune diseases, prior splenectomy, regular use of recreational drugs including nicotine and alcohol, obesity, regular medication use (except oral contraceptives) and pregnancy

Design outcomes

Primary

Measure	Time frame
Liver stiffness (kPa), measured using transient elastography (FibroScan®) and two-dimensional shear wave elastography (2D SWE) to assess agreement between the measurement methods; assessed once at the study visit; measurement performed using non-invasive elastography with at least 10 valid measurements per method	—

Secondary

Measure	Time frame
- Spleen stiffness (kPa), measured using transient elastography (TE) and two-dimensional shear wave elastography (2D SWE); assessed once at the study visit; measurement performed using non-invasive elastography with at least 10 valid measurements per method - Comparison of liver and spleen stiffness in Fontan patients and healthy controls; assessed once at the study visit; measurement performed using elastography - Association between liver and spleen stiffness and clinical parameters (body mass index, blood pressure, heart rate, oxygen saturation); assessed once at the study visit; data collection performed using clinical examination and a standardized case report form	—

Measure

Time frame

- Spleen stiffness (kPa), measured using transient elastography (TE) and two-dimensional shear wave elastography (2D SWE); assessed once at the study visit; measurement performed using non-invasive elastography with at least 10 valid measurements per method - Comparison of liver and spleen stiffness in Fontan patients and healthy controls; assessed once at the study visit; measurement performed using elastography - Association between liver and spleen stiffness and clinical parameters (body mass index, blood pressure, heart rate, oxygen saturation); assessed once at the study visit; data collection performed using clinical examination and a standardized case report form

—

Countries

Germany

Contacts

Public ContactMichelle Feike

Klinikum der Universität München

Michelle.Feike@campus.lmu.de+4989440073941

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026