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

• Sponsor: China-Japan Friendship Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05781659
• Collaborator: (none)
• Enrollment: 592
• Arms: 2
• Anticipated Duration (Months): 21.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pleural Effusion	Procedure: Ultrasound elastography guided pleural biopsy; Procedure: Traditional ultrasound guided pleural biopsy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 592 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: The Effectiveness and Safety of Ultrasound Elastography Guided Pleural Biopsy in the Differential Diagnosis of Benign and Malignant Pleural Effusion
• Anticipated Study Start Date: Mar 15, 2023
• Anticipated Primary Completion Date: Dec 24, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ultrasound elastography guided pleural biopsy group	Procedure: Ultrasound elastography guided pleural biopsy; The patients will undergo ultrasound elastography (Aixplorer V, SuperSonic Imagine, FRA) guided pleural biopsy.
Experimental: Traditional ultrasound-guided pleural biopsy group	Procedure: Traditional ultrasound guided pleural biopsy; The patients will undergo traditional ultrasound (Aixplorer V, SuperSonic Imagine, FRA) guided pleural biopsy.

Outcome Measures

Primary Outcome Measures

1. Efficacy of ultrasound elastography guided pleural biopsy versus traditional ultrasound-guided pleural biopsy for diagnosis of pleural effusion. [7 days after the biopsy]

   The diagnosis would be confirmed according to the pathological results.

Secondary Outcome Measures

1. Incidence rate of adverse events [7 days after the biopsy]

   Symptoms and signs

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• China-Japan Friendship Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gang Hou, Principal Investigator, China-Japan Friendship Hospital
• ClinicalTrials.gov Identifier: NCT05781659
• Other Study ID Numbers: 2022-NHLHCRF-LX-01-0201-04
• First Posted: Mar 23, 2023
• Last Update Posted: Mar 23, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pleural Effusion, Malignant; Pleural Effusion

Study Results

No Results Posted as of Mar 23, 2023