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

Not Applicable

Completed

• Conditions: Mediastinal Lymphadenopathy
• Interventions: Procedure: EBUS-TBMCB

• Registration Number: NCT04572984
• Lead Sponsor: Third Military Medical University

Brief 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.

Study Timeline

• Study First Submitted: 2020-09-12
• Study First Submitted QC: 2020-09-28
• Study Start: 2020-10-01
• Study First Posted: 2020-10-05
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-08
• Last Update Posted: 2022-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 271

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EBUS-TBNA-TBMCB	EBUS-TBMCB	endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was followed by endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (EBUS-TBMCB)

Primary Outcome Measures

Name	Time	Method
diagnostic yield	through study completion, an average of 1 year	percentage of patients for whom the EBUS procedures provided a definite diagnosis in each arm
prevalence of the procedure-related adverse events	through study completion, an average of 1 year	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

Secondary Outcome Measures

Name	Time	Method
sample size	through study completion, an average of 1 year	the area and diameter of sample obtained by each procedure
consumed time	through study completion, an average of 1 year	duration of each period in each procedure
sample adequacy	through study completion, an average of 1 year	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

Trial Locations

Locations (2)

The Army Medical University; 🇨🇳 Chongqing, Chongqing, China

Thoraxklinik - Heidelberg University Hospital; 🇩🇪 Heidelberg, Baden-Württemberg, Germany