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RecruitingNCT06226909Updated Feb 1, 2024

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

An interventional study of different types of ultrasound technique in Pleural Diseases, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-01.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
234
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Pleural Diseases

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03

In context

Pleural Diseases

49 studies on the registry are indexed under Pleural Diseases; 13 are open to participants now.

This study's planned enrollment of 234 is above the median of 91 across 34 interventional studies indexed under Pleural Diseases.

Browse Pleural Diseases studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with radiographic evidence of pleural disease

Exclusion criteria

Exclusion Criteria:

  • Age \< 18 y/o
  • Patients who cannot hold their breath for 5 seconds
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
234 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Proceduredifferent types of ultrasound technique

    Shear-wave elastography-guided or B-mode ultrasound-guided

06

What researchers measure

Primary outcomes

  1. The diagnostic yield of the two groups

    the pathology of pleural biopsies will be interpreted by cytopathologists

    Time frame: 6 months

Secondary outcomes

  1. Procedure time

    Procedure time

    Time frame: 1 day

  2. the rate of pneumothorax & hemothorax

    Safety

    Time frame: 1 day

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital
    Taipei City, 100, Taiwan
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06226909
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Jan 26, 2024
Start date
Jan 15, 2024
Primary completion
Aug 31, 2027 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Feb 1, 2024

Study contacts

Yao-Wen Kuo
Contact
kyw@ntu.edu.tw
0972651821
Yao-Wen Kuo
principal investigator · National Taiwan University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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