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

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ClinicalTrials.gov Identifier: NCT02413437
Recruitment Status : Unknown
Verified May 2017 by Kun Yan, Beijing Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : April 9, 2015
Last Update Posted : May 8, 2017
Sponsor:
Information provided by (Responsible Party):
Kun Yan, Beijing Cancer Hospital

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

Condition or disease Intervention/treatment Phase
Liver Neoplasms Other: CEUS guided biopsy Other: US guided biopsy Device: Ultrasound Not Applicable

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:

  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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2088 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Multi-center Study of Percutaneous Focal Liver Lesions Biopsy Guided by Contrast-Enhanced Ultrasound
Study Start Date : April 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CEUS guided biopsy
Biopsy was operated under contrast-enhanced ultrasound-guided
Other: CEUS guided biopsy
Biopsy was operated under contrast-enhanced ultrasound-guided.

Device: Ultrasound
US guided biopsy
Biopsy was operated under conventional ultrasound-guided
Other: US guided biopsy
Biopsy was operated under conventional ultrasound-guided.

Device: Ultrasound



Primary Outcome Measures :
  1. diagnostic accuracy [ Time Frame: 12 months ]
    diagnostic accuracy=(true positive+ ture negative)/number of parcitipants



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02413437


Contacts
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Contact: Kun Yan, master 0086-10-88196910 ydbz@vip.sina.com
Contact: Wei Wu, doctor 0086-10-88196140 wuvei@163.com

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Kun Yan, Master    8601088196910    ydbz@vip.sina.com   
Contact: Wei Wu, Doctor    8601088196140    wuvei@163.com   
Sponsors and Collaborators
Beijing Cancer Hospital
Investigators
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Principal Investigator: Kun Yan, master Beijing Cancer Hospital

Publications of Results:
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Responsible Party: Kun Yan, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT02413437     History of Changes
Other Study ID Numbers: 2014YJZ31
First Posted: April 9, 2015    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017
Keywords provided by Kun Yan, Beijing Cancer Hospital:
contrast-enhanced ultrasound
biopsy
Additional relevant MeSH terms:
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Liver Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases