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Clinical Trials/NCT02413437
NCT02413437
Unknown
Not Applicable

The Multi-center Study of Percutaneous Focal Liver Lesions Biopsy Guided by Contrast-Enhanced Ultrasound

Peking University Cancer Hospital & Institute1 site in 1 country2,088 target enrollmentApril 2015
ConditionsLiver Neoplasms

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Liver Neoplasms
Sponsor
Peking University Cancer Hospital & Institute
Enrollment
2088
Locations
1
Primary Endpoint
diagnostic accuracy
Last Updated
8 years ago

Overview

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: 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.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
December 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Peking University Cancer Hospital & Institute
Responsible Party
Principal Investigator
Principal Investigator

Kun Yan

Beijing Cancer Hospital

Peking University Cancer Hospital & Institute

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

Outcomes

Primary Outcomes

diagnostic accuracy

Time Frame: 12 months

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

Study Sites (1)

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