NCT03881410CompletedNot Applicable
The Efficacy of Shear-wave Elastography-guided Aspiration and Biopsy for Diagnosis in Lung Tumor: a Randomized Controlled Trial
National Taiwan University Hospital1 site in 1 country413 target enrollmentStarted: May 15, 2019Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 413
- Locations
- 1
- Primary Endpoint
- The diagnostic yield between two groups
Study Overview
Brief Summary
To use the shear-wave elastography to assist the transthoracic ultrasound-guided aspiration biopsy of peripheral lung tumor
- To identify the intra-tumor heterogeneity of elasticity
- To increase the diagnostic yield in ultrasound-guided transthoracic biopsy of subpleural pulmonary tumor
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •(1) Patients with radiographic evidence of pulmonary lesions
Exclusion Criteria
- •Age < 20 y/o
- •Patients who cannot hold their breath for 5 seconds
- •Inadequate shear-wave propagation of lung tumor
Arms & Interventions
Shear-wave elastography-guided
Experimental
Shear-wave elastography-guided bipsy
Intervention: different types of ultrasound technique (Procedure)
Convention ultrasound-guided
Active Comparator
Convention ultrasound-guided biopsy
Intervention: different types of ultrasound technique (Procedure)
Outcomes
Primary Outcomes
The diagnostic yield between two groups
Time Frame: 6 months
sensitivity, specificity, positive predictive value, and negative predictive value
Secondary Outcomes
- Procedure duration(1 day)
- Complication rate(1 day)
- Total times of the biopsy(1 day)
Investigators
Study Sites (1)
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