CEUS should be performed within 4 weeks before or after follow-up imaging or within 4 weeks before biopsy or surgical excision. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.
Advances in Diagnostic Imaging: The Value of Contrast-Enhanced Ultrasound for Liver
Search for terms x. Save this study. Warning You have reached the maximum number of saved studies Contrast-Enhanced Ultrasound Imaging in Diagnosing Liver Cancer in Patients With Cirrhosis The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
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Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Last Update Posted : May 30, See Contacts and Locations. Study Description. This clinical trial studies how well contrast-enhanced ultrasound imaging works in diagnosing liver cancer in patients with cirrhosis. Diagnostic procedures, such as contrast-enhanced ultrasound imaging, may help find and diagnose liver cancer. FDA Resources. Arms and Interventions.
Outcome Measures. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Exclusion Criteria: Patients who are pregnant or lactating Patients with focal liver observations less than 5 mm or greater than 5 cm in size Patients with contraindications to CEUS Patients with contraindications to both CT and MRI Patients who are medically unstable, terminally ill, or whose clinical course is unpredictable Liver nodule previously treated with trans-arterial or thermal ablation Patients who have received an investigational drug in the 30 days before CEUS, or will receive one within 72 hour after their CEUS exam.
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Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. The methodological quality of the included studies was evaluated. Data from eligible studies were used to estimate the pooled sensitivity, specificity, diagnostic odds ratio DOR , positive and negative likelihood ratio LR and summary receiver operating characteristic SROC curve.
Fifty-three eligible studies publication years ranged from to were selected according to inclusion criteria. The pooled positive and negative LRs were 6. The pooled DOR was The area under the SCOR curve was 0. Meta-regression and funnel plot indicated that sample size, type of contrast agents and publication bias might be the major sources of heterogeneity. According to the statistics, hepatocellular carcinoma HCC ranks the fifth most common cancer in men, the seventh in women [ 1 ].
Contrast-enhanced ultrasound for liver imaging: recent advances.
In recent years, micro-bubble based contrast agents have greatly improved the sensitivity as well as specificity for characterization of focal liver lesions FLLs during the ultrasound examinations [ 8 ]. A comprehensive literature search was conducted and revealed primary studies. Two studies were excluded due to duplicated publications.
Eventually, 53 eligible articles [ 9 — 61 ] were included in this meta-analysis. The detailed characteristics of the 53 studies are presented in Supplementary Table 1. The average age of the patients included in the eligible studies ranged from 44 to And there were lesions in total, with more than patients the numbers of patients were not mentioned in two studies.
The publication years ranged from to There were 34 studies conducted in Asian population, and 19 studies conducted in European and American population. The second generation contrast agents for CEUS SonoVue, Sonazoid and Definity were used in 40 studies along with the first generation contrast agent Levovist in 13 studies. The methodological quality of the included 53 studies is also summarized in Supplementary Table 1.
The meta-analysis results showed out that CEUS had high discriminatory powers of positive and negative test results. Funnel plot was conducted to assess the publication bias of the eligible studies. This indicated publication bias might be another source of heterogeneity. The utilization of microbubble-based ultrasound contrast agents along with the advanced US imaging techniques now allows stable observation and detailed evaluation of the tissue macro and microvascularization in both qualitative and quantitative manner [ 62 ].
These include the capability of real-time dynamic imaging, repetitive observation of tumor vascularity with multiple injections of these contrast agents, and the unique intravascular properties with excellent safety profile of the microbubbles, which allow the applications in patients with decreased renal function [ 8 ].
This license might result in a possible breakthrough in the field of CEUS study. The HCC multistep carcinogenesis from regenerative nodule to dysplastic nodule, ending with HCC leads to changes in blood supply within the nodule, which eventually forms increased tumoral arterial supply along with decreased normal arterial supply and portal supply as a consequent [ 66 ].
All the results implied that CEUS might be the excellent choice in the diagnostic work-up of liver malignant lesions. Nevertheless, there still exist some disadvantages of CEUS. The main drawback is the operator-dependency in US examination. While our comprehensive meta-analysis showed good pooled diagnostic values with relatively narrow confidence intervals, indicating with certain skills and experience, most of the sonographers might achieve closely high diagnostic capability. In our meta-analysis, great heterogeneity was revealed.
While there was no explicit threshold effect in this meta-analysis, indicating that the threshold effect was not the source of heterogeneity. Therefore, meta-regression analysis was performed to further explore the sources. And the results showed sample size and type of contrast agents might be the major sources of heterogeneity. Publication bias was also detected in this meta-analysis, suggesting it might be another source of heterogeneity. Moreover, some limitations in our meta-analysis should be acknowledged.
Firstly, due to the publication bias explored in this meta-analysis, the pooled estimates might be more optimistic than they actually are, as studies with positive data are more likely to be published. Secondly, some studies indicated that the vascularity in small nodule could not be easily assessed by CEUS [ 69 ]. Because of the advantages mentioned above, this approach would offer a major role in the diagnosis area, and additionally CEUS might become a first-line imaging tool in the future.
A comprehensive literature search of studies was carried out to identify eligible articles from the electronic databases, including Pubmed, Web of Science, and the Cochrane Library, up to February 1st, , and no limit to the starting time. Additional relevant search was also performed by manually searching the references of eligible studies and relevant reviews.
Two reviewers separately selected the eligible studies with disagreements disposed by consensus. Studies were excluded when they were 1 meta-analyses, reviews, letters, case reports or editorial articles; 2 not clinical studies; 3 not using CEUS to diagnose HCC; 4 the patients were not confirmed the diagnosis with the above standards.
If there existed more than one study by the same authors using the same cases published, either the most recently published studies or the study with the largest sample size was included. All eligible studies were used for data extraction by two reviewers independently. Disagreements were disposed by a third reviewer.
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The following characteristics were extracted from the eligible studies: first author, publication year, country, number of lesions and patients, clinical characteristics of the study sample age and gender ratio , gold standard, contrast agent, TP, TN, FP and FN. The methodological quality of eligible studies was assessed by the quality assessment tool for diagnostic accuracy studies QUADAS.
Softwares of Meta-Disc version 1. If one contingency table had a cell with no events, we added 0. The threshold effect was tested by the Spearman correlation coefficient.
Potential sources of heterogeneity were explored by regression analysis. The potential publication bias was assessed by the funnel plot. Lunshou Wei conceived and designed the overall study. Juanjuan Zhang and Yanyan Yu contributed to the reference collection and data management.
Ying Li performed the analysis. Juanjuan Zhang and Yanyan Yu wrote the manuscript.