The Efficacy of Shear-wave Elastography-guided Biopsy for Diagnosis in Pleural Disease

January 30, 2024 updated by: National Taiwan University Hospital

The Efficacy of Shear-wave Elastography-guided Biopsy for Diagnosis in Pleural Disease: a Randomized Controlled Trial

To investigate the information from shear-wave elastography on pleural tissues will improve the diagnosis of pleural diseases, as to increase the diagnostic yield in ultrasound-guided transthoracic pleura biopsy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

234

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei City, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with radiographic evidence of pleural disease

Exclusion Criteria:

  • Age < 18 y/o
  • Patients who cannot hold their breath for 5 seconds

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Shear-wave elastography-guided
based on the shear-wave elastography, the area with the highest elasticity value will be the target area to perform pleural biopsy for at least 6 times
Procedure: different types of ultrasound technique
Shear-wave elastography-guided or B-mode ultrasound-guided
Active Comparator: B-mode ultrasound-guided
based on the B-mode transthoracic ultrasound, the area with the maximal thickness will be the target area to perform pleural biopsy for at least 6 times
Procedure: different types of ultrasound technique
Shear-wave elastography-guided or B-mode ultrasound-guided

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The diagnostic yield of the two groups
Time Frame: 6 months
the pathology of pleural biopsies will be interpreted by cytopathologists
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure time
Time Frame: 1 day
Procedure time
1 day
the rate of pneumothorax & hemothorax
Time Frame: 1 day
Safety
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

January 17, 2024

First Posted (Actual)

January 26, 2024

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202311139RINC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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