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

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.

Study Overview

• Status: Completed
• Conditions: Mediastinal Lymphadenopathy
• Intervention / Treatment: Procedure: EBUS-TBMCB

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 Type: Interventional
• Enrollment (Actual): 271
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400037
      • The Army Medical University
• Germany
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany
      • Thoraxklinik - Heidelberg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EBUS-TBNA-TBMCB; endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was followed by endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (EBUS-TBMCB)	Procedure: EBUS-TBMCB; endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy was performed in experimental arm following EBUS-TBNA
No Intervention: EBUS-TBNA; endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
sample size	the area and diameter of sample obtained by each procedure	through study completion, an average of 1 year
consumed time	duration of each period in each procedure	through study completion, an average of 1 year
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

Collaborators and Investigators

• Sponsor: Third Military Medical University
• Collaborators: Heidelberg University
• Investigators: Principal Investigator: Ye Fan, PhD, Third Military Medical University; Principal Investigator: Felix Herth, Thoraxklinik - Heidelberg University Hospital

Publications and helpful links

General Publications

• Fan Y, Zhang AM, Wu XL, Huang ZS, Kontogianni K, Sun K, Fu WL, Wu N, Kuebler WM, Herth FJF. Transbronchial needle aspiration combined with cryobiopsy in the diagnosis of mediastinal diseases: a multicentre, open-label, randomised trial. Lancet Respir Med. 2022 Oct 21:S2213-2600(22)00392-7. doi: 10.1016/S2213-2600(22)00392-7. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: September 12, 2020
• First Submitted That Met QC Criteria: September 28, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 8, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphadenopathy
• Other Study ID Numbers: EBUS-TBMCB 2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No