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Study for diagnostic value and safety of transbronchial mediastinal cryobiopsy in mediastinal lesions

Study for diagnostic value and safety of transbronchial mediastinal cryobiopsy in mediastinal lesions

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900025531
Enrollment
Unknown
Registered
2019-08-31
Start date
2019-09-02
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Mediastinal adenopathy

Interventions

Gold Standard:endobronchial ultrasound-guided transbronchial needle aspiration.

Sponsors

The Second Affiliated Hospital of the Army Medical University
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 lesions are abundant in blood supply, close to large vessels, or other conditions detected by EBUS that indicates high risk to continue the biopsy; 4. The lesions are actually cysts or abscess; 5. Patients need for additional procedures other than EBUS examination (such as endobronchial biopsy); 6. Patients who have been 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;

Secondary

MeasureTime frame
sample size;sample adequacy;operation time;

Countries

Germany

Contacts

Public ContactYe Fan

Xinqiao Hospital

83728087@qq.com+86 13983815728

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026