Clinical trial NCT05781659: The Effectiveness and Safety of Ultrasound Elastography Guided Pleural Biopsy in the Differential Diagnosis of Benign and Malignant Pleural Effusion
Official title: The Effectiveness and Safety of Ultrasound Elastography Guided Pleural Biopsy in the Differential Diagnosis of Benign and Malignant Pleural Effusion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pleural Effusion
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 592
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Efficacy of ultrasound elastography guided pleural biopsy versus traditional ultrasound-guided pleural biopsy for diagnosis of pleural effusion.
timeFrame: 7 days after the biopsy
Secondary outcomes:
measure: Incidence rate of adverse events
timeFrame: 7 days after the biopsy
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Chest Hospital
state: Anhui
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Guiyang
country: China
facility: Gui Zhou Provincial People's Hospital
state: Guizhou
city: Changsha
country: China
facility: the Second Xiangya Hospital of Central South University
state: Hunan
city: Nanchang
country: China
facility: the First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Shenyang
country: China
facility: the First Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: The Tenth People's Hospital of Shenyang
state: Liaoning
city: Kunming
country: China
facility: the First People's Hospital of Yunnan Provience
state: Yunnan
city: Hangzhou
country: China
facility: the Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: