NCT03811431

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

January 22, 2019

Status Verified

January 1, 2019

Enrollment Period

9 years

First QC Date

January 16, 2019

Last Update Submit

January 17, 2019

Conditions

Liver Diseases

Keywords

contrast enhanced ultrasound guided liver biopsyultrasound guided liver biopsyfocal liver lesionshepatocellular carcinomaadvanced chronic liver disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    In patients in whom a final histological diagnosis can not be achieved with the use of contrast enhanced or ultrasound guidance a second liver biopsy will be considered if appropriate in the next 3-4 weeks. In cases where a second liver biopsy will be judged not to be necessary a follow-up using imaging techniques will be performed until a final diagnosis is reached.

    From randomisation until the first documented histological diagnosis. In cases with a negative diagnosis based on histology imaging follow-up using CT or MRI will be carried on for a period of at least 12 months.

Study Arms (2)

CEUS guidance

EXPERIMENTAL

SonoVue 2, 4 ml

Procedure: Contrast enhanced ultrasound guided liver biopsy

Conventional US guidance

EXPERIMENTAL

No drugs

Procedure: Contrast enhanced ultrasound guided liver biopsy

Interventions

Contrast enhanced ultrasound guided liver biopsyPROCEDURE

Conventional liver biopsy

Also known as: Ultrasound
CEUS guidanceConventional US guidance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • tumors located tin sonography blind areas
  • refuse to sign the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional Institute of Gastroenterology and Hepatology "Octavian Fodor"

Cluj-Napoca, Please Enter the State Or Province, 400126, Romania

RECRUITING

MeSH Terms

Conditions

Liver DiseasesCarcinoma, Hepatocellular

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Digestive System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Central Study Contacts

Tudor Mocan, MD

CONTACT

+40 799861946Mocac.Tudor@umfcluj.ro

Zeno Sparchez, MD, PhD

CONTACT

+40 0729890911zsparchez@yahoo.co.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Investigator
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: A prospective parallel group clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD Associate Specialist

Study Record Dates

First Submitted

January 16, 2019

First Posted

January 22, 2019

Study Start

January 1, 2011

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

January 22, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome measures will be made available

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
Data available within 12 months of study completion
Access Criteria
Data access request will be reviewed by an external Independent review panel.

Locations

RO(1)