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

Not Applicable

• Conditions: Liver Neoplasms
• Interventions: Other: CEUS guided biopsy; Other: US guided biopsy; Device: Ultrasound

• Registration Number: NCT02413437
• Lead Sponsor: Peking University Cancer Hospital & Institute

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-01
• Study First Submitted QC: 2015-04-08
• Study First Posted: 2015-04-09
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-04
• Last Update Posted: 2017-05-08
• Primary Completion: 2017-06
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2088

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
US guided biopsy	Ultrasound	Biopsy was operated under conventional ultrasound-guided
CEUS guided biopsy	CEUS guided biopsy	Biopsy was operated under contrast-enhanced ultrasound-guided
US guided biopsy	US guided biopsy	Biopsy was operated under conventional ultrasound-guided
CEUS guided biopsy	Ultrasound	Biopsy was operated under contrast-enhanced ultrasound-guided

Primary Outcome Measures

Name	Time	Method
diagnostic accuracy	12 months	diagnostic accuracy=（true positive+ ture negative)/number of parcitipants

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China