Ultrasound-guided Cryobiopsy of Mediastinal/Hilar Lymph Nodes

Not Applicable

Recruiting

• Conditions: Lung Cancer (NSCLC)

• Registration Number: NCT06921681
• Lead Sponsor: University of Zurich

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.

Study Timeline

• Study Start: 2025-03-07
• Study First Submitted: 2025-03-10
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-03
• Last Update Submitted: 2025-04-03
• Study First Posted: 2025-04-10
• Last Update Posted: 2025-04-10
• Primary Completion: 2029-04-01
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Jürgen Hetzel; 🇨🇭 Basel, Switzerland