A Trial on Contrast-enhanced Ultrasound Versus Conventional Ultrasound Guided Biopsy of Liver Neoplasms

Liver Neoplasms Clinical Trial

Official title:

The Multi-center Study of Percutaneous Focal Liver Lesions Biopsy Guided by Contrast-Enhanced Ultrasound

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02413437
• Other study ID #: 2014YJZ31
• Status: Recruiting
• Phase: N/A
• First received: April 1, 2015
• Last updated: May 4, 2017
• Start date: April 2015
• Est. completion date: December 2017

Study information

• Verified date: May 2017
• Source: Beijing Cancer Hospital
• Contact: Kun Yan, master
• Phone: 0086-10-88196910
• Email: ydbz[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2088
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Neoplasms
• Neoplasms

Intervention

Other:
• CEUS guided biopsy
Biopsy was operated under contrast-enhanced ultrasound-guided.
• US guided biopsy
Biopsy was operated under conventional ultrasound-guided.

Device:
• Ultrasound

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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 Interven — View 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. — View Citation

Schlottmann K, Klebl F, Zorger N, Feuerbach S, Schölmerich 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic accuracy	diagnostic accuracy=(true positive+ ture negative)/number of parcitipants	12 months