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

Primary Purpose

Mediastinal Lymphadenopathy

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
EBUS-TBMCB
Sponsored by
Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Mediastinal Lymphadenopathy

Eligibility Criteria

15 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Army Medical University
  • Thoraxklinik - Heidelberg University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

EBUS-TBNA-TBMCB

EBUS-TBNA

Arm Description

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

endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was performed

Outcomes

Primary Outcome Measures

diagnostic yield
percentage of patients for whom the EBUS procedures provided a definite diagnosis in each arm
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

Secondary Outcome Measures

sample size
the area and diameter of sample obtained by each procedure
consumed time
duration of each period in each procedure
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

Full Information

First Posted
September 12, 2020
Last Updated
October 8, 2022
Sponsor
Third Military Medical University
Collaborators
Heidelberg University
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1. Study Identification

Unique Protocol Identification Number
NCT04572984
Brief Title
Transbronchial Mediastinal Cryobiopsy Combined With EBUS-TBNA in the Diagnosis of Mediastinal Lesions
Official Title
The Study for Diagnostic Value and Safety of Transbronchial Mediastinal Cryobiopsy Combined With EBUS-TBNA in Mediastinal Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Military Medical University
Collaborators
Heidelberg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mediastinal Lymphadenopathy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
271 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EBUS-TBNA-TBMCB
Arm Type
Experimental
Arm Description
endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was followed by endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (EBUS-TBMCB)
Arm Title
EBUS-TBNA
Arm Type
No Intervention
Arm Description
endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was performed
Intervention Type
Procedure
Intervention Name(s)
EBUS-TBMCB
Intervention Description
endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy was performed in experimental arm following EBUS-TBNA
Primary Outcome Measure Information:
Title
diagnostic yield
Description
percentage of patients for whom the EBUS procedures provided a definite diagnosis in each arm
Time Frame
through study completion, an average of 1 year
Title
prevalence of the procedure-related adverse events
Description
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
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
sample size
Description
the area and diameter of sample obtained by each procedure
Time Frame
through study completion, an average of 1 year
Title
consumed time
Description
duration of each period in each procedure
Time Frame
through study completion, an average of 1 year
Title
sample adequacy
Description
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
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ye Fan, PhD
Organizational Affiliation
Third Military Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Felix Herth
Organizational Affiliation
Thoraxklinik - Heidelberg University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Army Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400037
Country
China
Facility Name
Thoraxklinik - Heidelberg University Hospital
City
Heidelberg
State/Province
Baden-Württemberg
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36279880
Citation
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. 2023 Mar;11(3):256-264. doi: 10.1016/S2213-2600(22)00392-7. Epub 2022 Oct 22.
Results Reference
derived

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

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