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

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

Study Overview

• Status: Completed
• Conditions: Lung Tumor
• Intervention / Treatment: Procedure: different types of ultrasound technique

• Study Type: Interventional
• Enrollment (Actual): 413
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei City, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shear-wave elastography-guided; Shear-wave elastography-guided bipsy	Procedure: different types of ultrasound technique; Shear-wave elastography-guided or Convention ultrasound-guided
Active Comparator: Convention ultrasound-guided; Convention ultrasound-guided biopsy	Procedure: different types of ultrasound technique; Shear-wave elastography-guided or Convention ultrasound-guided

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Yao-Wen Kuo, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Actual): December 2, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 15, 2019
• First Submitted That Met QC Criteria: March 17, 2019
• First Posted (Actual): March 19, 2019

Study Record Updates

• Last Update Posted (Actual): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 24, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 201812180RINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data (IPD) that underlie the results reported in this article, including data dictionaries, will be available upon reasonable request. Additionally, the study protocol, statistical analysis plan, Stata code, and informed consent forms will be shared. Data access will begin three months after publication and remain available for five years. Researchers with methodologically sound proposals may access the data to achieve aims in the approved proposal. Requests for access should be directed to kyw@ntu.edu.tw, and requestors will be required to sign a data access agreement.
• IPD Sharing Time Frame: Data access will begin three months after publication and remain available for five years.
• IPD Sharing Access Criteria: Researchers with methodologically sound proposals may access the data to achieve aims in the approved proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No