Contrast Enhanced Ultrasound Guidance Biopsy for the Diagnosis of Liver Tumors (ConCLUDe)

January 17, 2019 updated by: Tudor Mocan, Iuliu Hatieganu University of Medicine and Pharmacy

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.

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

Study Overview

Status

Unknown

Conditions

Detailed Description

A prospective parallel group clinical trial will be performed. The study protocol was implemented in our Institute starting January 2011 ending January 1 2020. During this period, all patients with a suspicion of primary liver neoplasia either on CT or MRI will be evaluated in different departments from our Institute for possible inclusion. Patients with a typical aspect of benign FLLs will not be included in the study. Patients fulfilling the following 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 or an international normalized ratio < 1.6; will be further on sent to the department of interventional ultrasound. ). All patients referred to interventional department will underwent a B-mode ultrasound (1 investigator) testing the feasibility of performing liver biopsy. At this time point the conspicuity of the tumors will be recorded into either poorly or not poorly visible. Included patients will be randomly divided by another investigator (T.M.) without access to the previous US, CT or MRI report into two groups: a group that will underwent US guided liver biopsy (USLB) and another one who will underwent CEUS guided liver biopsy (CEUSLB). The randomization will be made based of flip coin technique. The side of the coin (heads-USLB, tails CEUSLB) determined the assignment of each subject. All biopsies will be performed by the same investigator (Z.S.) with an experience of more than 8 years in ultrasound interventions. Patients assigned to USLB or CEUSLB will be blinded. The investigators assessing the outcomes will not be informed about the LB technique used in each patient. The reasons for performing biopsy will be either inconclusive CT/MRI findings , or patients with a typical pattern of HCC on CT/MRI in whom a histological diagnosis is necessary in order to start systemic therapy (sorafenib). Different from other major society's guidelines, in our country a histological diagnosis of HCC is mandatory in patients referred for sorafenib treatment. Patients with small FLLs (BCLC 0 or A) and typical aspect of HCC on CT/MRI will be sent directly to surgery or radiofrequency ablation according to EASL guidelines.

Study Type

Interventional

Enrollment (Anticipated)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Please Enter The State Or Province
      • Cluj-Napoca, Please Enter The State Or Province, Romania, 400126

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CEUS guidance
SonoVue 2, 4 ml
Conventional liver biopsy
Other Names:
  • Ultrasound
Experimental: Conventional US guidance
No drugs
Conventional liver biopsy
Other Names:
  • Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

January 16, 2019

First Submitted That Met QC Criteria

January 17, 2019

First Posted (Actual)

January 22, 2019

Study Record Updates

Last Update Posted (Actual)

January 22, 2019

Last Update Submitted That Met QC Criteria

January 17, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

Data available within 12 months of study completion

IPD Sharing Access Criteria

Data access request will be reviewed by an external Independent review panel.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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