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

Overview

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

• Device Cryobiopsy 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 gr
• Device Cryobiopsy 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 gr

Primary outcome measures

• Diagnostic yield [Time frame: from date of randomization to the time of the first documented results, assessed up to 100 weeks]

Secondary outcome measures (4)

• overall rate of suitability for histopathological examination [Time frame: 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) [Time frame: 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 [Time frame: from date of randomization to the time of the first documented results, assessed up to100 weeks]
• time of the procedure [Time frame: from the date of randomization to the time of the first documented results, assessed up to 100 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

Switzerland · 1 center

• Jürgen Hetzel — Basel

Publications

• 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. PMID 36279880
• 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. PMID 33958432

Identifiers

NCT: NCT06921681 · 2024-00885

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗