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Clinical study on diagnostic value of transbronchial cryobiopsy in mediastinal lymphoma

Clinical study on the diagnostic value of ultrasound-guided transbronchial cryobiopsy in mediastinal lymphoma: a multicenter, randomized, controlled, open-label trial

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600116394
Enrollment
Unknown
Registered
2026-01-09
Start date
2025-08-27
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

mediastinal lymphoma

Interventions

Index test:EBUS-TBNA(Endobronchial Ultrasound-guided Transbronchial Needle Aspiration), transbronchial cryobiopsy

Sponsors

The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. 15 = 10 mm in the short axis, as identified by thoracic CT or PET-CT; 4. Patients must have completed all required preoperative laboratory tests and necessary examinations (e.g., cardiac ultrasound, CTA) to rule out contraindications; 5. Patients are informed and capable of providing written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with newly diagnosed lymphoma from whom sufficient pathological tissue can be obtained via superficial lymph node biopsy; 2. Contraindications to endoscopic procedures, such as severe cardiopulmonary disease, coagulation disorders, anesthesia intolerance, uncontrolled psychiatric conditions; 3. Intraoperative endobronchial ultrasound exploration of the lesion failed to detect the target lesion despite > 20 minutes of attempts; 4. Lesions with abundant blood supply or near large vessels or other conditions detected by ultrasound which indicate high risks to continue the biopsy; 5. Lesions confirmed as cysts or abscesses by the ultrasound; 6. Patients who have participated in other clinical trials within 3 months; 7. Any other conditions considered to be inappropriate to be involved in this trial.

Design outcomes

Primary

MeasureTime frame
diagnostic yield;Incidence of adverse events;

Secondary

MeasureTime frame
diagnostic safety;sample adequacy;sample size;operation time;Time consuming operation;Sensitivity;Specificity;

Countries

China

Contacts

Public ContactFan Ye

The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)

fan_ye_sat@hotmail.com+86 139 8381 5728

Outcome results

None listed

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