Clinical trial · Interventional
Ultrasound-guided Cryobiopsy of Mediastinal/Hilar Lymph Nodes
Transbronchial EBUS-guided TBNA and Cryobiopsy of Mediastinal Lymph Nodes in Patients Nonsuspicious for Lung Cancer, Using Different Cryoprobe Freezing Times
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
EBUS-guided cryobiopsy of mediastinal and hilar lymph nodes has shown to be a useful diagnostic tool to obtain tissue for histological analysis and further targeted therapies in lung malignancies. Due to the large size and better quality of the tissue samples, a higher diagnostic yield than with transbronchial needle aspiration (TBNA) can be expected, especially in non-solid tumors. In previous studies different biopsy protocols were used. The freezing time of cryoprobe (which defines the sample sizes) ranged from 3 to 7 s and the number of biopsies was between 1 and 4 samples. It is therefore unclear what freezing times and biopsy frequency are required to obtain the best histological information.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer (NSCLC) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryobiopsy lymphnode group 3 sec | Device | — | UNRESOLVED |
| Cryobiopsy of lymph nodes group 6 sec | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- group 6 sec
- description
- EBUS-guided CBs of mediastinal/hilar lymph nodes will be done with 6 seconds of cryoprobe freezing time ("group 6sec.") before the biopsy together with the whole EBUS bronchoscope is extracted.
- interventionNames
- Device: Cryobiopsy of lymph nodes group 6 sec
- type
- ACTIVE_COMPARATOR
- label
- group 3 sec
- description
- EBUS-guided CBs of mediastinal/hilar lymph nodes will be done with 3 seconds of cryoprobe freezing time ("group 3sec.") before the biopsy together with the whole EBUS bronchoscope is extracted.
- interventionNames
- Device: Cryobiopsy lymphnode group 3 sec
Primary outcomes (1)
- measure
- Diagnostic yield
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * At least one mediastinal lesion or hilar 1 cm or longer in the short axis requiring diagnostic bronchoscopy * Age between 18 and 90 years * Written informed consent after participant's information Exclusion Criteria: * Age \< 18 and \> 90 years * Lacking ability to form an informed consent (including impaired judgement, communication barriers) * Contraindication against bronchoscopy (e.g. co-morbidities) * Mediastinal abscess or cyst * Extraordinary blood supply of the lesion visualized by EBUS bronchoscope * INR \> 1.5 or Thrombocytes \< 100 G/l * Clopidogrel or other new antiplatelet drugs within 7 days before biopsy (salicylic acid alone allowed) * Anticoagulation with NOAC within 48 hours before biopsy * Pulmonary lesions suspicious of lung carcinoma
References
Publications (2)
- BACKGROUNDFan Y, Zhang AM, Wu XL, Huang ZS, Kontogianni K, Sun K, Fu WL, Wu N, Kuebler WM, Herth FJF. Transbronchial needle aspiration combined with cryobiopsy in the diagnosis of mediastinal diseases: a multicentre, open-label, randomised trial. Lancet Respir Med. 2023 Mar;11(3):256-264. doi: 10.1016/S2213-2600(22)00392-7. Epub 2022 Oct 22. PMID 36279880
- BACKGROUNDZhang J, Guo JR, Huang ZS, Fu WL, Wu XL, Wu N, Kuebler WM, Herth FJF, Fan Y. Transbronchial mediastinal cryobiopsy in the diagnosis of mediastinal lesions: a randomised trial. Eur Respir J. 2021 Dec 9;58(6):2100055. doi: 10.1183/13993003.00055-2021. Print 2021 Dec. PMID 33958432