Contrast Enhanced Ultrasound Guidance Biopsy for the Diagnosis of Liver Tumors

NCT ID: NCT03811431

Last Updated: 2019-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-01
• Study Completion Date: 2020-01-01

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

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.

Conditions

Liver Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

CEUS guidance

SonoVue 2, 4 ml

Group Type: EXPERIMENTAL

Contrast enhanced ultrasound guided liver biopsy

Intervention Type: PROCEDURE

Conventional liver biopsy

Conventional US guidance

No drugs

Group Type: EXPERIMENTAL

Contrast enhanced ultrasound guided liver biopsy

Intervention Type: PROCEDURE

Conventional liver biopsy

Interventions

Contrast enhanced ultrasound guided liver biopsy

Conventional liver biopsy

Intervention Type: PROCEDURE

Other Intervention Names

Ultrasound

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Iuliu Hatieganu University of Medicine and Pharmacy

OTHER

Sponsor Role: lead

Responsible Party

Tudor Mocan

MD Associate Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Regional Institute of Gastroenterology and Hepatology "Octavian Fodor"

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

Site Status: RECRUITING

Countries

Romania

Central Contacts

Tudor Mocan, MD

Role: CONTACT

Mocac.Tudor@umfcluj.ro

+40 799861946

Zeno Sparchez, MD, PhD

Role: CONTACT

zsparchez@yahoo.co.uk

+40 0729890911

Facility Contacts

Tudor Mocan

Role: primary

Mocan.Tudor@umfcluj.ro

+40 799 861946

Ioana Rusu

Role: backup

ioana.russu@yahoo.com

Other Identifiers

BIOPTICON

Identifier Type: -

Identifier Source: org_study_id