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The study on diagnostic utility of combination of EBUS-TBNA and transbronchial mediastinal cryobiopsy guided by endobronchial ultrasound (EBUS-TBMCB) in mediastinal lesions

The study on diagnostic utility of combination of EBUS-TBNA and transbronchial mediastinal cryobiopsy guided by endobronchial ultrasound (EBUS-TBCB) in mediastinal lesions

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000030373
Enrollment
Unknown
Registered
2020-02-29
Start date
2020-03-02
Completion date
Unknown
Last updated
2022-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mediastinal lesion

Interventions

TBNA,&#32
TBCB&#32
and&#32
TBFB&#32
ultrasound&#32
guidance. 2.Group&#32
2:&#32
Gold Standard:Transbronchial needle aspiration and transbronchial forceps biopsy guided by endobronchial ultrasound.
Index test:1.Group&#32

Sponsors

Xinqiao Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged >= 15 years; 2. Patients with at least one mediastinal lesion with short-axis >= 1 cm that is detected by thoracic image; 3. Patients with recently discovered mediastinal lesions, clinical respiratory symptoms of cough, expectoration, thoracalgia, apnea, or complicated lung lesions implicated by thoracic image, which indicates the need of biopsy to identify the etiology; 4. Patients should have undergone necessary preoperative laboratory examinations and other examinations such as cardiac ultrasound or CTA when necessary, in order to exclude potential contradictions; 5. Patients are informed and the consent form are acquired.

Exclusion criteria

Exclusion criteria: 1.Patients with contradictions to endoscopic examination, such as severe cardiopulmonary diseases, coagulation disorders, intolerance to anesthesia or endoscopic operation, psychiatric disorders, or severe neurosis, and so on; 2.The EBUS procedure fails to detect the mediastinal lesion; 3.The mediastinal lesions are actually cysts or abscess; 4.Patients could not provide full informed consentsuch as with severe neurosis or mental diseases; 5.Patients need for additional procedures other than EBUS examination (such asendobronchial biopsy); 6.Patients have been previously randomised to an arm of the present trial or involved in other clinical trials in the recent 3 months; 7.Patients have any other conditions that are considered to be inappropriate to be involved in this study.

Design outcomes

Primary

MeasureTime frame
diagnostic yield;diagnostic safety;

Countries

Germany

Contacts

Public Contact??

Xinqiao Hospital

83728087@qq.com+86 13983815728

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026