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

Mediastinal Lymphadenopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04572984
• Other study ID #: EBUS-TBMCB 2020
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: October 2022
• Source: Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: April 30, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age >=15 years;
• More than one mediastinal lesions with diameter >= 1cm was detected by thoracic CT;
• Indication of biopsy to identify the etiology, including recently discovered mediastinal lesions or combination of clinical respiratory symptoms and complicated lung lesions implicated by thoracic image ;
• Completion of necessary preoperative laboratory examination and other examinations such as cardiac ultrasound or CTA when necessary, in order to exclude potential contradictions;
• Informed consent form achievement.

Exclusion Criteria:

• Contradictions to bronchoscopy examination such as severe cardiopulmonary diseases, coagulation disorders, intolerance to anesthesia or endoscopic operation and so on;
• Failure to detect the mediastinal lesions in ultrasonic landscape;
• Cysts or abscess;
• Requirements for additional procedures other than EBUS examination (such as endobronchial biopsy);
• Psychiatric disorders or severe neurosis.
• Participation in other clinical experiments in recent 3 months;
• Any other conditions considered to be inappropriate to be involved in this study.

Related Conditions & MeSH terms

• Lymphadenopathy
• Mediastinal Lymphadenopathy

Intervention

Procedure:
• EBUS-TBMCB
endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy was performed in experimental arm following EBUS-TBNA

Locations

Country	Name	City	State
China	The Army Medical University	Chongqing	Chongqing
Germany	Thoraxklinik - Heidelberg University Hospital	Heidelberg	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
Third Military Medical University	Heidelberg University

Countries where clinical trial is conducted

China,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic yield	percentage of patients for whom the EBUS procedures provided a definite diagnosis in each arm	through study completion, an average of 1 year
Primary	prevalence of the procedure-related adverse events	the ratio of the number of patients who had adverse events caused by the procedure and the number of all the patients who have undergone this procedure in each arm	through study completion, an average of 1 year
Secondary	sample size	the area and diameter of sample obtained by each procedure	through study completion, an average of 1 year
Secondary	consumed time	duration of each period in each procedure	through study completion, an average of 1 year
Secondary	sample adequacy	the ratio of the number of patients with adequate sample by the procedure and the number of all the patients who have undergone this procedure	through study completion, an average of 1 year