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

Primary Purpose

Liver Neoplasms

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

CEUS guided biopsy

US guided biopsy

Ultrasound

About this trial

This is an interventional diagnostic trial for Liver Neoplasms focused on measuring contrast-enhanced ultrasound, biopsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Beijing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

CEUS guided biopsy

US guided biopsy

Arm Description

Biopsy was operated under contrast-enhanced ultrasound-guided

Biopsy was operated under conventional ultrasound-guided

Outcomes

Primary Outcome Measures

diagnostic accuracy

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02413437

First Posted

April 1, 2015

Last Updated

May 4, 2017

Sponsor

Peking University Cancer Hospital & Institute

1. Study Identification

Unique Protocol Identification Number

NCT02413437

Brief Title

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

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Unknown status

Study Start Date

April 2015 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University Cancer Hospital & Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Neoplasms

Keywords

contrast-enhanced ultrasound, biopsy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2088 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CEUS guided biopsy

Arm Type

Experimental

Arm Description

Biopsy was operated under contrast-enhanced ultrasound-guided

Arm Title

US guided biopsy

Arm Type

Other

Arm Description

Biopsy was operated under conventional ultrasound-guided

Intervention Type

Other

Intervention Name(s)

CEUS guided biopsy

Intervention Description

Biopsy was operated under contrast-enhanced ultrasound-guided.

Intervention Type

Other

Intervention Name(s)

US guided biopsy

Intervention Description

Biopsy was operated under conventional ultrasound-guided.

Intervention Type

Device

Intervention Name(s)

Ultrasound

Primary Outcome Measure Information:

Title

diagnostic accuracy

Description

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

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kun Yan, master

Phone

0086-10-88196910

ydbz@vip.sina.com

First Name & Middle Initial & Last Name or Official Title & Degree

Wei Wu, doctor

Phone

0086-10-88196140

wuvei@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kun Yan, master

Organizational Affiliation

Peking University Cancer Hospital & Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Cancer Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100142

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kun Yan, Master

Phone

8601088196910

ydbz@vip.sina.com

First Name & Middle Initial & Last Name & Degree

Wei Wu, Doctor

Phone

8601088196140

wuvei@163.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

11270776

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.

Results Reference

result

PubMed Identifier

15095120

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.

Results Reference

result

PubMed Identifier

16928941

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.

Results Reference

result

PubMed Identifier

11118924

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.

Results Reference

result

PubMed Identifier

12324817

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.

Results Reference

result

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

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