Lung Cancer (NSCLC)
Conditions
Keywords
EBUS, Cryobiopsy, TBNA, Bronchoscopy
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.
Interventions
DEVICECryobiopsy of lymph nodes group 6 sec
Included patients receive transbronchial access with EBUS needle (19, 21 or 22 gauge needle) Hereafter, three times EBUS-TBNA followed by four EBUS-guided-CBs with a 1.1mm cryoprobe will be performed. Included patients are 1:1 randomized to receive CB with cryoprobe activated for either 3 sec of freezing time (group 3sec) or 6 sec. of freezing time (group 6sec) before the biopsy together with the whole EBUS bronchoscope is extracted. The EBUS-guided CB will be conducted four times in each group. Aiming access to one lymph node if one lymph node cannot be punctured, another lymph node will be chosen. Even if tissue-extraction out of a lymph node via cryoprobe fails once to several times, overall no more than 4 attempts for cryobiopsy will be done
DEVICECryobiopsy lymphnode group 3 sec
Included patients receive transbronchial access with EBUS needle (19, 21 or 22 gauge needle) Hereafter, three times EBUS-TBNA followed by four EBUS-guided-CBs with a 1.1mm cryoprobe will be performed. Included patients are 1:1 randomized to receive CB with cryoprobe activated for either 3 sec of freezing time (group 3sec) or 6 sec. of freezing time (group 6sec) before the biopsy together with the whole EBUS bronchoscope is extracted. The EBUS-guided CB will be conducted four times in each group. Aiming access to one lymph node if one lymph node cannot be punctured, another lymph node will be chosen. Even if tissue-extraction out of a lymph node via cryoprobe fails once to several times, overall no more than 4 attempts for cryobiopsy will be done
Sponsors
Aarau Cantonal Hospital (KSA)
Waid City Hospital, Zurich
Kantonsspital Winterthur KSW
Unispital Basel
Spital Uster AG, Uster, Switzerland
Clinique des Grangettes, Chêne-Bougeries
Insel Gruppe AG, University Hospital Bern
Réseau Hospitalier Neuchâtelois
University of Lausanne Hospitals
Cantonal Hospital of St. Gallen
Ospedale Regionale Bellinzona e Valli
HUG - Hôpitaux universitaires de Genève
Kantonsspital Chur, Switzerland
Hôpital du Valais
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield | from date of randomization to the time of the first documented results, assessed up to 100 weeks | Primary outcome measure is diagnostic yield according to the ATS consensus 2024 of EBUS-guided CB using two different freezing times (3sec./6.sec.). |
Secondary
| Measure | Time frame |
|---|---|
| overall rate of suitability for histopathological examination | from the date of randomization to the time of the first documented results, assessed up to 100 weeks |
| the size of the harvested tissue (mm2) | from date of randomization to the time of the first documented results, assessed up to 100 months |
| ), isolated and cumulative diagnostic yield of the first, second, third and fourth cryobiopsy | from date of randomization to the time of the first documented results, assessed up to100 weeks |
| time of the procedure | from the date of randomization to the time of the first documented results, assessed up to 100 weeks |
Countries
Switzerland
Contacts
Primary ContactCarolin Steinack
Outcome results
None listed