Clinical trial NCT06921681: Ultrasound-guided Cryobiopsy of Mediastinal/Hilar Lymph Nodes
Official title: Transbronchial EBUS-guided TBNA and Cryobiopsy of Mediastinal Lymph Nodes in Patients Nonsuspicious for Lung Cancer, Using Different Cryoprobe Freezing Times
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer (NSCLC)
Keywords: EBUS
Cryobiopsy
TBNA
Bronchoscopy
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Aarau Cantonal Hospital (KSA)
name: Waid City Hospital, Zurich
name: Kantonsspital Winterthur KSW
name: Unispital Basel
name: Spital Uster AG, Uster, Switzerland
name: Clinique des Grangettes, Chêne-Bougeries
name: Insel Gruppe AG, University Hospital Bern
name: Réseau Hospitalier Neuchâtelois
name: University of Lausanne Hospitals
name: Cantonal Hospital of St. Gallen
name: Ospedale Regionale Bellinzona e Valli
name: HUG - Hôpitaux universitaires de Genève
name: Kantonsspital Chur, Switzerland
name: Hôpital du Valais
First posted: 2025-04-10
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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. This study will analyze whether the freezing time influences the diagnostic yield in CB of mediastinal lymphadenopathies. Additionally we will evaluate the influence of the number of biopsies on the diagnostic yield.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic yield
timeFrame: from date of randomization to the time of the first documented results, assessed up to 100 weeks
Secondary outcomes:
measure: overall rate of suitability for histopathological examination
timeFrame: from the date of randomization to the time of the first documented results, assessed up to 100 weeks
measure: the size of the harvested tissue (mm2)
timeFrame: from date of randomization to the time of the first documented results, assessed up to 100 months
measure: ), isolated and cumulative diagnostic yield of the first, second, third and fourth cryobiopsy
timeFrame: from date of randomization to the time of the first documented results, assessed up to100 weeks
measure: time of the procedure
timeFrame: from the date of randomization to the time of the first documented results, assessed up to 100 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Jürgen Hetzel
Study officials:
References:
citation: Fan 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.
citation: Zhang 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.