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Search / Trial NCT05781659

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

Launched by CHINA-JAPAN FRIENDSHIP HOSPITAL · Mar 12, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new method called ultrasound elastography guided pleural biopsy to see how well it can differentiate between benign (non-cancerous) and malignant (cancerous) pleural effusions, which is the buildup of fluid in the space around the lungs. The trial aims to determine if this method is both effective and safe compared to the traditional ultrasound-guided pleural biopsy. Participants will be patients who have unexplained pleural effusion and have already undergone certain tests like a chest CT scan and fluid analysis.

To be eligible for the trial, patients must be between 18 and 85 years old and have pleural effusion that has shown negative results in previous tests. However, those with clear signs of cancer in their pleural fluid or who have other serious health issues will not be able to participate. If you join the trial, you can expect to undergo either the new ultrasound elastography guided biopsy or the traditional method during your visit. This research could help improve how doctors understand and treat pleural effusion in the future.

Gender

ALL

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.

About China Japan Friendship Hospital

China-Japan Friendship Hospital is a leading clinical research institution dedicated to advancing healthcare through innovative medical research and trials. Established as a collaborative effort between China and Japan, the hospital integrates cutting-edge technology with traditional medical practices, fostering a multidisciplinary approach to patient care and clinical studies. The institution is committed to enhancing therapeutic outcomes and improving patient safety while adhering to rigorous ethical standards. With a diverse team of experienced healthcare professionals and researchers, China-Japan Friendship Hospital plays a pivotal role in addressing global health challenges and contributing to medical knowledge through its extensive clinical trial programs.

Locations

Changsha, Hunan, China

Nanchang, Jiangxi, China

Beijing, Beijing, China

Shenyang, Liaoning, China

Hangzhou, Zhejiang, China

Hefei, Anhui, China

Guiyang, Guizhou, China

Shenyang, Liaoning, China

Kunming, Yunnan, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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