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Application of transbronchial needle aspiration biopsy guided by ultrasound bronchoscopy (EBUS-TBNA) combined with transbronchial mediastinal cryobiopsy (EBMC) in the diagnosis of sarcoidosis: a single center, randomized controlled study

Application of transbronchial needle aspiration biopsy guided by ultrasound bronchoscopy (EBUS-TBNA) combined with transbronchial mediastinal cryobiopsy (EBMC) in the diagnosis of sarcoidosis: a single center, randomized controlled study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500101647
Enrollment
Unknown
Registered
2025-04-28
Start date
2025-03-10
Completion date
Unknown
Last updated
2025-05-05

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

Conditions

Patients with suspected stage I/II intrathoracic sarcoidosis

Interventions

Gold Standard:The pathology is an exclusive granulomatous lesion, which has improved after treatment or follow-up.
Index test:EBMC combined with EBUS-TBNA method
EBUS-TBNA method.

Sponsors

Shanghai Pulmonary Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age greater than or equal to 18 years old, regardless of gender. 2. Patients with mediastinal and/or hilar lymph node enlargement detected by chest CT or PET and ultimately suspected of sarcoidosis by three respiratory physicians. 3. Patients who can tolerate general anesthesia, ultrasound bronchoscopy, lymph node biopsy, and biopsy. 4. At least one group of mediastinal or hilar lymph nodes can be punctured, and the shortest axis of the lymph nodes is greater than 1cm. 5. No tumor or infection evidence was found before taking the biopsy pathology specimen. 6. Patients must be able to fully understand the informed consent form, agree to participate in the study, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients who have received anti tuberculosis or glucocorticoid therapy within 1.6 months. 2. Patients with suspected tumors in clinical and imaging studies of lung lesions, or patients with confirmed tumors through other means such as lung biopsy. 3. Patients with lung lesions considered to be infected. 4. Patients who failed to detect mediastinal lesions during EBUS operation. 5. Patients with contraindications for general anesthesia bronchoscopy and mediastinal lymph node biopsy. 6. Patients suspected or diagnosed with mediastinal cysts or abscesses. 7. Patients who have been diagnosed through other methods such as mediastinoscopy or thoracoscopy lymph node biopsy before bronchoscopy examination. 8. Patients who have participated in other clinical studies within the past 3 months. 9. Patients who require lung biopsy or bronchial mucosal biopsy for definitive diagnosis before or during bronchoscopy. 10. Patients who are deemed unsuitable as subjects for this trial by the responsible physician or the physician in charge of the trial.

Design outcomes

Primary

MeasureTime frame
Sensitivity;specificity;Positive predictive value;Negative predictive value;Accuracy of diagnosis;

Countries

China

Contacts

Public ContactLi qiuhong, Gu ye

Department of Respiratory and Critical care Medicine, Shanghai Pulmonary Hospital

qiuhongl@126.com+86 187 2174 0608

Outcome results

None listed

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