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

Peking University Cancer Hospital & Institute

Status: Unknown

Conditions: Liver Neoplasms

Treatments: Other: CEUS guided biopsy; Device: Ultrasound; Other: US guided biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT02413437

2014YJZ31

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,088 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,088 participants in 2 patient groups

CEUS guided biopsy

Experimental group

Description:

Biopsy was operated under contrast-enhanced ultrasound-guided

Treatment:

Device: Ultrasound

Other: CEUS guided biopsy

US guided biopsy

Other group

Description:

Biopsy was operated under conventional ultrasound-guided

Treatment:

Device: Ultrasound

Other: US guided biopsy