Clinical trial · Interventional
Contrast Enhanced Ultrasound Guidance Biopsy for the Diagnosis of Liver Tumors
Real Time Contrast-enhanced Compared to Conventional Ultrasound Guided Biopsy in the Diagnosis of Hepatic Tumors on a Background of Advanced Chronic Liver Disease. A Prospective Clinical Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main purpose of this study is to compare contrast-enhanced ultrasound guided liver biopsy (CEUS-LB) with conventional ultrasound guided liver biopsy (US-LB) in the diagnosis of liver tumors developed on a background of advanced chronic liver diseases. All patients referred to our department with a CT/MRI diagnosis of hepatic neoplasia will be randomly assigned to either CEUS-LB or US-LB. All LB will be performed by the same investigator. For the randomisation the flip coin technique will be used. One investigator without access to previous C/MRI/US report will do the randomization
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast enhanced ultrasound guided liver biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CEUS guidance
- description
- SonoVue 2, 4 ml
- interventionNames
- Procedure: Contrast enhanced ultrasound guided liver biopsy
- type
- EXPERIMENTAL
- label
- Conventional US guidance
- description
- No drugs
- interventionNames
- Procedure: Contrast enhanced ultrasound guided liver biopsy
Primary outcomes (1)
- measure
- Number of patients in whom contrast enhanced ultrasound guided liver biopsy leads to the final diagnosis as compared to conventional ultrasound guided liver biopsy. The final diagnosis will be assessed based on histological examination.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * presence of cirrhosis or other chronic liver disease (according to a liver stiffness evaluated by transient elastography higher than 10 kilopascals) * Child-Pugh score no higher than B7 and absence of perihepatic ascites * platelet count \> 50.000 per mm3 * international normalized ratio \< 1.6 Exclusion Criteria: * tumors located tin sonography blind areas * refuse to sign the informed consent
References
Publications (0)
Data not yet available