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RecruitingNCT05781659Updated Mar 12, 2024

The Effectiveness and Safety of Ultrasound Elastography Guided Pleural Biopsy in the Differential Diagnosis of Benign and Malignant Pleural Effusion

An interventional study of Ultrasound elastography guided pleural biopsy and Traditional ultrasound guided pleural biopsy in Pleural Effusion, sponsored by China-Japan Friendship Hospital. Recruiting at 9 sites in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-03-12.

Sponsored by China-Japan Friendship Hospital · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Apr 2023; still recruiting 3 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
592
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

The goal of this clinical trial is to evaluate the diagnostic effcacy and safety of ultrasound elastography guided pleural biopsy in the differential diagnosis of benign and malignant pleural effusion. The main question it aims to answer are: the effectiveness and safety of ultrasound elastography guided pleural biopsy in the differential diagnosis of benign and malignant pleural effusion.

Participants will undergo ultrasound elastography guided pleural biopsy or traditional ultrasound-guided pleural biopsy.

02

Conditions studied

  • Pleural Effusion

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03

In context

Pleural Effusion

241 studies on the registry are indexed under Pleural Effusion; 50 are open to participants now.

This study's planned enrollment of 592 is above the median of 80 across 142 interventional studies indexed under Pleural Effusion.

Browse Pleural Effusion studies →

Lead sponsor

China-Japan Friendship Hospital is the lead sponsor of 178 studies on the registry; 111 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients with unexplained pleural effusion (patients with pleural effusion with negative aspiration)
  2. Sign the form
  3. The patient must have chest CT, biochemical examination of pleural fluid, cytological examination of pleural fluid and other data before operation

Exclusion criteria

Exclusion Criteria:

  1. The cytological examination of pleural fluid indicates "highly suspicious" patients (unless the cytological examination results of patients are inconsistent with clinical manifestations and CT examination). The pleural fluid cytology proved to be malignant. Patients with severe pleural adhesion who cannot undergo medical thoracoscopic examination will not be randomly selected, and elastic ultrasound-guided can be performed after , as a subgroup of population analysis. Those who cannot tolerate closed pleural biopsy due to severe cardiopulmonary dysfunction and poor general condition Coagulation dysfunction. Leakage. The age is less than 18 years old.
  2. The pleural fluid cytology proved to be malignant.
  3. Patients with severe pleural adhesion who cannot undergo medical thoracoscopic examination will not be randomly selected, and elastic ultrasound-guided biopsy can be performed after informed consent, as a subgroup of population analysis.
  4. Those who cannot tolerate closed pleural biopsy due to severe cardiopulmonary dysfunction and poor general condition
  5. Coagulation dysfunction.
  6. transudate
  7. The age is less than 18 years old.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
592 participants (estimated)

Study arms

  • Experimental
    Ultrasound elastography guided pleural biopsy group

    Procedure: Ultrasound elastography guided pleural biopsy

  • Experimental
    Traditional ultrasound-guided pleural biopsy group

    Procedure: Traditional ultrasound guided pleural biopsy

Interventions

  • ProcedureUltrasound elastography guided pleural biopsy

    The patients will undergo ultrasound elastography (Aixplorer V, SuperSonic Imagine, FRA) guided pleural biopsy.

  • ProcedureTraditional ultrasound guided pleural biopsy

    The patients will undergo traditional ultrasound (Aixplorer V, SuperSonic Imagine, FRA) guided pleural biopsy.

06

What researchers measure

Primary outcomes

  1. Efficacy of ultrasound elastography guided pleural biopsy versus traditional ultrasound-guided pleural biopsy for diagnosis of pleural effusion.

    The diagnosis would be confirmed according to the pathological results.

    Time frame: 7 days after the biopsy

Secondary outcomes

  1. Incidence rate of adverse events

    Symptoms and signs

    Time frame: 7 days after the biopsy

07

Study locations

9 of 9 sites recruiting
  • Anhui Chest Hospital
    Hefei, Anhui 230000, China
    Recruiting
    • Tang Fei, MM · Contact
  • China-Japan Friendship Hospital
    Beijing, Beijing 100000, China
    Recruiting
    • Tong Run, MD · Contact
  • Gui Zhou Provincial People's Hospital
    Guiyang, Guizhou 550000, China
    Recruiting
    • Ye Xianwei, MD · Contact
  • the Second Xiangya Hospital of Central South University
    Changsha, Hunan 410000, China
    Recruiting
    • Chen Yan, MD · Contact
  • the First Affiliated Hospital of Nanchang University
    Nanchang, Jiangxi 330000, China
    Recruiting
    • Xu Fei, MD · Contact
  • the First Hospital of China Medical University
    Shenyang, Liaoning 110000, China
    Recruiting
    • Ma Jiangwei, MD · Contact
  • The Tenth People's Hospital of Shenyang
    Shenyang, Liaoning 110000, China
    Recruiting
    • LI Chengjun, MM · Contact
  • the First People's Hospital of Yunnan Provience
    Kunming, Yunnan 650000, China
    Recruiting
    • Zhang Yunhui, MD · Contact
  • the Second Affiliated Hospital Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310000, China
    Recruiting
    • Xia Yang, MD · Contact
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05781659
Responsible party
Gang Hou (Principal Investigator, China-Japan Friendship Hospital) — Principal investigator
First posted
Mar 23, 2023
Start date
Apr 7, 2023
Primary completion
Dec 24, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Mar 12, 2024

Study contacts

Mingming Deng, MD
Contact
isdeng1017@163.com
86 18801336854

Oversight

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

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