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A clinical study on the diagnostic value and safety of ultrasound-guided transbronchial cryobiopsy (EBUS-TBCB) for mediastinal lesions

A clinical study on the diagnostic value and safety of ultrasound-guided transbronchial cryobiopsy (EBUS-TBCB) for mediastinal lesions

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100052279
Enrollment
Unknown
Registered
2021-10-24
Start date
2021-10-29
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

mediastinal lesions

Interventions

Gold Standard:1. The gold standard for malignant tumors: the pathological results of ultrasound-guided transbronchial forceps biopsy or surgery
2. Benign disease gold standard: all patients diagnosed with benign disease were followed up for more than 6 months, and the final diagnosis was made by an expert panel based on cl

Sponsors

The First Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 16 years; 2. Chest imaging examination indicates the presence of mediastinal lesions in at least one site (short diameter >=10mm); 3. After improving laboratory examinations, imaging examinations, routine bronchoscopy and TBNA examinations, the diagnosis cannot be made; 4. Tumors are considered after TBNA but the specimens are insufficient for immunohistochemistry, genetic testing, etc.; 5. Informed consent to participate in this clinical study and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Contraindications related to bronchoscopy such as severe cardiopulmonary disease, coagulation dysfunction, anesthesia intolerance, mental illness or severe neurosis; 2. Mediastinal lesions were not detected by intraoperative ultrasound bronchoscopy; 3. Intraoperative ultrasound found that the risk of biopsy is high, and it is not suitable to continue biopsy, such as lesions with rich blood flow or close to large blood vessels; 4. The lesions are cysts or abscesses; 5. Participated in other clinical trials in the last 3 months; 6. Unable to cooperate with the study for any reason or the investigator thinks it is not suitable to be included in this trial.

Design outcomes

Primary

MeasureTime frame
Diagnostic efficiency;Biopsy success rate;

Secondary

MeasureTime frame
The sample quality;Size of specimen;

Countries

China

Contacts

Public ContactGuo Shuliang

The First Affiliated Hospital of Chongqing Medical University

guoshuliang2021@126.com+86 13101363078

Outcome results

None listed

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