Clinical trial NCT02413437: A Trial on Contrast-enhanced Ultrasound Versus Conventional Ultrasound Guided Biopsy of Liver Neoplasms
Official title: The Multi-center Study of Percutaneous Focal Liver Lesions Biopsy Guided by Contrast-Enhanced Ultrasound
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Neoplasms
Keywords: contrast-enhanced ultrasound
biopsy
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2015-04-09
Enrollment: 2088
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to estimate the clinical value of contrast-enhanced ultrasound in percutaneous biopsy for liver occupied lesion.

Detailed description: The patients with liver neoplasms who need receive percutaneous biopsy were randomized into contrast-enhanced ultrasound(CEUS) group and conventional ultrasound(US) group.The aims include:

1. Comparison the diagnostic accuracy rate, specificity and sensitivity between CEUS and US group.
2. Comparison the diagnostic accuracy rate specificity and sensitivity between smaller(\<3cm) and larger(≥3cm) nodule group.
3. To explore operating strategy of contrast-enhanced ultrasound guided biopsy.
4. To evaluate economic efficiency of contrast-enhanced ultrasound guided biopsy compared with conventional ultrasound guided biopsy.

Eligibility criteria: Inclusion Criteria:

* patients with liver occupied lesion who cannot be diagnosed by imaging examination or need pathological results

Exclusion Criteria:

* severe anemia
* PLT\<60000/mm3,prothrombin activityprothrombin time activity\<70%
* women during menstruation, pregnancy, child birth and baby nursing period
* patients with severe mental disorder
* cardiopulmonary failure

Primary outcomes:
measure: diagnostic accuracy
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Kun Yan, master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rossi P, Sileri P, Gentileschi P, Sica GS, Forlini A, Stolfi VM, De Majo A, Coscarella G, Canale S, Gaspari AL. Percutaneous liver biopsy using an ultrasound-guided subcostal route. Dig Dis Sci. 2001 Jan;46(1):128-32. doi: 10.1023/a:1005571904713.
citation: Schlottmann K, Klebl F, Zorger N, Feuerbach S, Scholmerich J. Contrast-enhanced ultrasound allows for interventions of hepatic lesions which are invisible on convential B-mode. Z Gastroenterol. 2004 Apr;42(4):303-10. doi: 10.1055/s-2004-812712.
citation: Wu W, Chen MH, Yin SS, Yan K, Fan ZH, Yang W, Dai Y, Huo L, Li JY. The role of contrast-enhanced sonography of focal liver lesions before percutaneous biopsy. AJR Am J Roentgenol. 2006 Sep;187(3):752-61. doi: 10.2214/AJR.05.0535.
citation: Bang N, Bachmann Nielsen M, Vejborg I, Mellon Mogensen A. Clinical report: contrast enhancement of tumor perfusion as a guidance for biopsy. Eur J Ultrasound. 2000 Dec;12(2):159-61. doi: 10.1016/s0929-8266(00)00108-7.
citation: Caturelli E, Biasini E, Bartolucci F, Facciorusso D, Decembrino F, Attino V, Bisceglia M. Diagnosis of hepatocellular carcinoma complicating liver cirrhosis: utility of repeat ultrasound-guided biopsy after unsuccessful first sampling. Cardiovasc Intervent Radiol. 2002 Jul-Aug;25(4):295-9. doi: 10.1007/s00270-001-0123-6. Epub 2002 Mar 27.