Ultrasound-guided Cryobiopsy of Mediastinal/Hilar Lymph Nodes

University of Zurich (UZH)

Status: Enrolling

Conditions: Lung Cancer (NSCLC)

Treatments: Device: Cryobiopsy lymphnode group 3 sec; Device: Cryobiopsy of lymph nodes group 6 sec

Study type: Interventional

Funder types: Other

Identifiers

NCT06921681

2024-00885

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

group 6 sec

Active Comparator group

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.

Treatment:

Device: Cryobiopsy of lymph nodes group 6 sec

group 3 sec

Active Comparator group

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.

Treatment:

Device: Cryobiopsy lymphnode group 3 sec