Liver NeoplasmsNCT02413437
A Trial on Contrast-enhanced Ultrasound Versus Conventional Ultrasound Guided Biopsy of Liver Neoplasms
A study testing CEUS guided biopsy, US guided biopsy and Ultrasound in people with Liver Neoplasms, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
The purpose of this study is to estimate the clinical value of contrast-enhanced ultrasound in percutaneous biopsy for liver occupied lesion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Neoplasms
- What is being tested?
- CEUS guided biopsy, US guided biopsy and Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,088 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with liver occupied lesion who cannot be diagnosed by imaging examination or need pathological results
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Kun Yan, Master, 8601088196910, ydbz@vip.sina.com
Wei Wu, Doctor, 8601088196140, wuvei@163.com
About this study
Official title: The Multi-center Study of Percutaneous Focal Liver Lesions Biopsy Guided by Contrast-Enhanced Ultrasound
The purpose of this study is to estimate the clinical value of contrast-enhanced ultrasound in percutaneous biopsy for liver occupied lesion.
Read the 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.
- Conditions
- Liver Neoplasms
- Being tested
- CEUS guided biopsy, US guided biopsy, Ultrasound
- Keywords
- contrast-enhanced ultrasound, biopsy
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEUS guided biopsyOther
Biopsy was operated under contrast-enhanced ultrasound-guided.
US guided biopsyOther
Biopsy was operated under conventional ultrasound-guided.
UltrasoundDevice
| Study group | Role | What they receive |
|---|---|---|
| CEUS guided biopsy | Experimental | Biopsy was operated under contrast-enhanced ultrasound-guided Receives: Other: CEUS guided biopsy; Device: Ultrasound |
| US guided biopsy | Other | Biopsy was operated under conventional ultrasound-guided Receives: Other: US guided biopsy; Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accuracy
diagnostic accuracy=（true positive+ ture negative)/number of parcitipants
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,088 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun Yan, Peking University Cancer Hospital & Institute
- Investigators
- Kun Yan, master, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413437
- Sponsor's protocol ID
- 2014YJZ31
- Status last verified
- May 2017
- First submitted
- 1 Apr 2015
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 11270776Schlottmann 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.
PubMed 15095120Wu 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.
PubMed 16928941Bang 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.
PubMed 11118924Caturelli 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.
PubMed 12324817Wu 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.
PubMed 35916680
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Multi-center Study of Percutaneous Focal Liver Lesions Biopsy Guided by Contrast-Enhanced Ultrasound
- ClinicalTrials.gov ID
- NCT02413437
- Acronym / sponsor ID
- 2014YJZ31
- Conditions
- Liver Neoplasms
- Keywords
- contrast-enhanced ultrasound, biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,088 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 9 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CEUS guided biopsy | Experimental | Other: CEUS guided biopsy, Device: UltrasoundBiopsy was operated under contrast-enhanced ultrasound-guided |
| US guided biopsy | Other | Other: US guided biopsy, Device: UltrasoundBiopsy was operated under conventional ultrasound-guided |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with liver occupied lesion who cannot be diagnosed by imaging examination or need pathological results
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CEUS guided biopsyBiopsy was operated under contrast-enhanced ultrasound-guided. | Other | CEUS guided biopsy |
| US guided biopsyBiopsy was operated under conventional ultrasound-guided. | Other | US guided biopsy |
| Ultrasound | Device | CEUS guided biopsy, US guided biopsy |
Primary outcome
diagnostic accuracy
Time frame: 12 months
diagnostic accuracy=（true positive+ ture negative)/number of parcitipants
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Results publication: PubMed 11270776Rossi 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 publication: PubMed 15095120Schlottmann 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 publication: PubMed 16928941Wu 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 publication: PubMed 11118924Bang 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 publication: PubMed 12324817Caturelli 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.
- Derived from this study: PubMed 35916680Wu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kun Yan, master principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CEUS guided biopsy, US guided biopsy and Ultrasound in people with Liver Neoplasms, run by Peking University Cancer Hospital & Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kun Yan, master (0086-10-88196910, ydbz@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic accuracy (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02413437, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.