Ultrasound-guided Cryobiopsy of Mediastinal/Hilar Lymph Nodes

NCT06921681 | Recruiting DMC

• 1 other identifier: 2024-00885
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer (NSCLC)

Keywords

EBUS; Cryobiopsy; TBNA; Bronchoscopy

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield

  Primary outcome measure is diagnostic yield according to the ATS consensus 2024 of EBUS-guided CB using two different freezing times (3sec./6.sec.).

  from date of randomization to the time of the first documented results, assessed up to 100 weeks

Secondary Outcomes (4)

• 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

Study Arms (2)

group 6 sec

ACTIVE COMPARATOR

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.

Device: Cryobiopsy of lymph nodes group 6 sec

group 3 sec

ACTIVE COMPARATOR

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.

Device: Cryobiopsy lymphnode group 3 sec

Interventions

Cryobiopsy of lymph nodes group 6 sec DEVICE

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

group 6 sec

Cryobiopsy lymphnode group 3 sec DEVICE

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

group 3 sec

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• Aarau Cantonal Hospital (KSA): collaborator
• Waid City Hospital, Zurich: collaborator
• Kantonsspital Winterthur KSW: collaborator
• Unispital Basel: collaborator
• Spital Uster AG, Uster, Switzerland: collaborator
• Clinique des Grangettes, Chêne-Bougeries: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator
• Réseau Hospitalier Neuchâtelois: collaborator
• University of Lausanne Hospitals: collaborator
• Cantonal Hospital of St. Gallen: collaborator
• Ospedale Regionale Bellinzona e Valli: collaborator
• HUG - Hôpitaux universitaires de Genève: collaborator
• Kantonsspital Chur, Switzerland: collaborator
• Hôpital du Valais: collaborator

Study Sites (1)

Jürgen Hetzel

Basel, Switzerland

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Central Study Contacts

Carolin Steinack

CONTACT

0041 44 255 8689; carolin.steinack@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: April 10, 2025
• Study Start: March 7, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

CH (1)