The Efficacy of Shear-wave Elastography-guided Aspiration and Biopsy for Diagnosis in Lung Tumor

The Efficacy of Shear-wave Elastography-guided Aspiration and Biopsy for Diagnosis in Lung Tumor: a Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03881410

Enrollment

413

Registered

2019-03-19

Start date

2019-05-15

Completion date

2023-12-31

Last updated

2024-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Tumor

Brief summary

To use the shear-wave elastography to assist the transthoracic ultrasound-guided aspiration biopsy of peripheral lung tumor 1. To identify the intra-tumor heterogeneity of elasticity 2. To increase the diagnostic yield in ultrasound-guided transthoracic biopsy of subpleural pulmonary tumor

Interventions

PROCEDUREdifferent types of ultrasound technique

Shear-wave elastography-guided or Convention ultrasound-guided

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

(1) Patients with radiographic evidence of pulmonary lesions

Exclusion criteria

1. Age \< 20 y/o 2. Patients who cannot hold their breath for 5 seconds 3. Inadequate shear-wave propagation of lung tumor

Design outcomes

Primary

Measure	Time frame	Description
The diagnostic yield between two groups	6 months	sensitivity, specificity, positive predictive value, and negative predictive value

Secondary

Measure	Time frame	Description
Total times of the biopsy	1 day	Total times of the biopsy
Procedure duration	1 day	Time duration
Complication rate	1 day	Complications like pneumothorax or hemothorax

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026