NCT02413437

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,088

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 9, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

2.2 years

First QC Date

April 1, 2015

Last Update Submit

May 4, 2017

Conditions

Liver Neoplasms

Keywords

contrast-enhanced ultrasoundbiopsy

Outcome Measures

Primary Outcomes (1)

  • diagnostic accuracy

    diagnostic accuracy=（true positive+ ture negative)/number of parcitipants

    12 months

Study Arms (2)

CEUS guided biopsy

EXPERIMENTAL

Biopsy was operated under contrast-enhanced ultrasound-guided

Other: CEUS guided biopsyDevice: Ultrasound

US guided biopsy

OTHER

Biopsy was operated under conventional ultrasound-guided

Other: US guided biopsyDevice: Ultrasound

Interventions

CEUS guided biopsyOTHER

Biopsy was operated under contrast-enhanced ultrasound-guided.

CEUS guided biopsy
US guided biopsyOTHER

Biopsy was operated under conventional ultrasound-guided.

US guided biopsy
UltrasoundDEVICE
CEUS guided biopsyUS guided biopsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Related Publications (6)

  • 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.

    PMID: 11270776RESULT

  • 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.

    PMID: 15095120RESULT

  • 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.

    PMID: 16928941RESULT

  • 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.

    PMID: 11118924RESULT

  • 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.

    PMID: 12324817RESULT

  • 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.

    PMID: 35916680DERIVED

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Kun Yan, master

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kun Yan, master

CONTACT

0086-10-88196910ydbz@vip.sina.com

Wei Wu, doctor

CONTACT

0086-10-88196140wuvei@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Beijing Cancer Hospital

Study Record Dates

First Submitted

April 1, 2015

First Posted

April 9, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

May 8, 2017

Record last verified: 2017-05

Locations

CN(1)