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

NCT ID: NCT02413437

Last Updated: 2017-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2088 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Liver Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CEUS guided biopsy

Biopsy was operated under contrast-enhanced ultrasound-guided

Group Type EXPERIMENTAL

CEUS guided biopsy

Intervention Type OTHER

Biopsy was operated under contrast-enhanced ultrasound-guided.

Ultrasound

Intervention Type DEVICE

US guided biopsy

Biopsy was operated under conventional ultrasound-guided

Group Type OTHER

US guided biopsy

Intervention Type OTHER

Biopsy was operated under conventional ultrasound-guided.

Ultrasound

Intervention Type DEVICE

Interventions

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CEUS guided biopsy

Biopsy was operated under contrast-enhanced ultrasound-guided.

Intervention Type OTHER

US guided biopsy

Biopsy was operated under conventional ultrasound-guided.

Intervention Type OTHER

Ultrasound

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Cancer Hospital & Institute

OTHER

Sponsor Role lead

Responsible Party

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Kun Yan

Beijing Cancer Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kun Yan, master

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

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Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kun Yan, master

Role: CONTACT

0086-10-88196910

Wei Wu, doctor

Role: CONTACT

0086-10-88196140

Facility Contacts

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Wei Wu, Doctor

Role: backup

8601088196140

Kun Yan, Master

Role: primary

8601088196910

References

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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.

Reference Type RESULT
PMID: 11270776 (View on PubMed)

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.

Reference Type RESULT
PMID: 15095120 (View on PubMed)

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.

Reference Type RESULT
PMID: 16928941 (View on PubMed)

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.

Reference Type RESULT
PMID: 11118924 (View on PubMed)

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.

Reference Type RESULT
PMID: 12324817 (View on PubMed)

Wu W, Jing X, Xue GQ, Zhu XL, Wang J, Du RQ, Lv B, Wang KF, Yan JP, Zhang ZY, Li MD, Kono Y, Yan K. A Multicenter Randomized Controlled Study of Contrast-enhanced US versus US-guided Biopsy of Focal Liver Lesions. Radiology. 2022 Dec;305(3):721-728. doi: 10.1148/radiol.212317. Epub 2022 Aug 2.

Reference Type DERIVED
PMID: 35916680 (View on PubMed)

Other Identifiers

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2014YJZ31

Identifier Type: -

Identifier Source: org_study_id

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