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Clinical study on the diagnostic value of transbronchial needle aspiration biopsy combined with frozen biopsy and biopsy forceps in mediastinal diseases

Clinical study on the diagnostic value of transbronchial needle aspiration biopsy combined with frozen biopsy and biopsy forceps in mediastinal diseases

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109221
Enrollment
Unknown
Registered
2025-09-15
Start date
2025-09-15
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

Mediastinal disorders

Interventions

Experimental group:forceps
Control group:Under the guidance of bronchial ultrasound, four TBNA biopsies, three 1.5mm biopsy forceps biopsies and one 1.1mm ultrafine cryoprobe biopsy were performed sequently

Sponsors

Respiratory and Critical Care Medical Center, The Second Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.18 years old =10mm); 3. For newly developed mediastinal space-occupying lesions, or recent respiratory symptoms such as coughing, expectoration, chest pain, shortness of breath, or the discovery of combined lung lesions on imaging, a biopsy is required to determine the cause or the nature of the mediastinal space-occupying lesion. 4. Complete the routine preoperative examination of bronchoscopy. If necessary, complete the examinations such as echocardiography, D2 polymeric imaging, and CT angiography to rule out contraindications. 5. Informed consent to participate in this clinical study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Intraoperative ultrasound bronchoscopy was used to explore the lesion for more than 20 minutes but still no lesion was detected. 2. The lesion is an abscess or a cyst; 3. Combined with mental illness or severe neurosis; 4. The patient has participated in other clinical studies in the last three months; 5. For any reason, one cannot cooperate with the research or is not suitable to be included in this trial.

Design outcomes

Primary

MeasureTime frame
Needle depth;Time consuming operation;Intraoperative complications;TBNA, biopsy forceps and cryobiopsy operation time;Lesion size;

Countries

China

Contacts

Public ContactYe Fan

The Second Affiliated Hospital of Army Medical University

alchol@tmmu.edu.cn+86 23 6877 4462

Outcome results

None listed

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