NCT04572984

Transbronchial Mediastinal Cryobiopsy Combined With EBUS-TBNA in the Diagnosis of Mediastinal Lesions

The Study for Diagnostic Value and Safety of Transbronchial Mediastinal Cryobiopsy Combined With EBUS-TBNA in Mediastinal Lesions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 271 (actual)
• Sponsor: Third Military Medical University · Academic / Other
• Sex: All
• Age: 15 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The clinical study is aimed to prospectively evaluate the diagnostic accuracy and the safety of adding transbronchial mediastinal cryobiopsy to standard sampling in mediastinal diseases.

Detailed description

A traditional method, endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was used to be compared. The patients involved were randomly divided into two groups. In the experimental group, EBUS-TBMCB was performed following EBUS-TBNA while in the other group, EBUS-TBNA was performed respectively. The samples obtained in the two groups were analyzed by the pathologists. Patients were followed up for confirming the diagnosis and complications. The diagnostic accuracy and prevalence of procedure-related adverse events were compared between the 2 groups.

Conditions

• Mediastinal Lymphadenopathy

Interventions

Type	Name	Description
PROCEDURE	EBUS-TBMCB	endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy was performed in experimental arm following EBUS-TBNA

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-04-01
• Completion: 2022-04-30
• First posted: 2020-10-05
• Last updated: 2022-10-13

Locations

2 sites across 2 countries: China, Germany