Evaluating ultrasound elastography for diagnosing pleural effusion

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

This study is testing if a new ultrasound technique for taking pleural biopsies can better tell the difference between harmless and harmful fluid in the lungs compared to the standard method for people with unexplained pleural effusion.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 592 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: China-Japan Friendship Hospital (Academic / other)
• Locations: 9 sites (Hefei, Anhui and 8 other locations)
• Trial ID: NCT05781659 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the effectiveness and safety of ultrasound elastography guided pleural biopsy compared to traditional ultrasound-guided pleural biopsy in differentiating between benign and malignant pleural effusions. Participants with unexplained pleural effusion will undergo either of the two biopsy methods. The study will analyze diagnostic efficacy and safety outcomes to determine the best approach for accurate diagnosis.

Who should consider this trial

Good fit: Ideal candidates are patients with unexplained pleural effusion who have undergone necessary preliminary examinations.

Not a fit: Patients with cytological evidence of malignancy or severe pleural adhesion may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve diagnostic accuracy for patients with pleural effusion, leading to better treatment decisions.

How similar studies have performed: While similar diagnostic approaches have been explored, this specific use of ultrasound elastography for pleural biopsy is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Patients with unexplained pleural effusion (patients with pleural effusion with negative aspiration)
2. Sign the informed consent 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:

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 biopsy can be performed after informed consent, 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.

Where this trial is running

Hefei, Anhui and 8 other locations

• Anhui Chest Hospital — Hefei, Anhui, China (Recruiting)
• China-Japan Friendship Hospital — Beijing, Beijing, China (Recruiting)
• Gui Zhou Provincial People's Hospital — Guiyang, Guizhou, China (Recruiting)
• the Second Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
• the First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• the First Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
• The Tenth People's Hospital of Shenyang — Shenyang, Liaoning, China (Recruiting)
• the First People's Hospital of Yunnan Provience — Kunming, Yunnan, China (Recruiting)
• the Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Mingming Deng, MD

Conditions Pleural Effusion