Clinical trial NCT04572984: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mediastinal Lymphadenopathy
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
Collaborators: name: Heidelberg University
First posted: 2020-10-05
Enrollment: 271
Sex: ALL
Minimum age (years): 15
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: diagnostic yield
timeFrame: through study completion, an average of 1 year
measure: prevalence of the procedure-related adverse events
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: sample size
timeFrame: through study completion, an average of 1 year
measure: consumed time
timeFrame: through study completion, an average of 1 year
measure: sample adequacy
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Army Medical University
state: Chongqing
city: Heidelberg
country: Germany
facility: Thoraxklinik - Heidelberg University Hospital
state: Baden-Württemberg
Study officials:
affiliation: Third Military Medical University
name: Ye Fan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thoraxklinik - Heidelberg University Hospital
name: Felix Herth
role: PRINCIPAL_INVESTIGATOR
References:
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.