Contrast Enhanced Ultrasound Guidance Biopsy for the Diagnosis of Liver Tumors
Contrast Enhanced Ultrasound Guidance Biopsy for the Diagnosis of Liver Tumors
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
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.
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