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NCT Number: NCT06921681

Ultrasound-guided Cryobiopsy of Mediastinal/Hilar Lymph Nodes

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.

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Key information

Conditions

Lung Cancer (NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jürgen Hetzel

Basel, Switzerland

Location status: Recruiting

Location contact

Jahn Kathleen

PRINCIPAL_INVESTIGATOR

Jürgen Hetzel

CONTACT

[email protected]

+41 61 265 51 84

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Diagnostic yield

    Time frame: 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 outcomes

  1. 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

  2. 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

  3. ), 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

  4. time of the procedure

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

Study contacts

Contact information is provided by the study sponsor or research team.

Carolin Steinack

CONTACT

[email protected]

0041 44 255 8689

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

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

Registry information

Official study title

Transbronchial EBUS-guided TBNA and Cryobiopsy of Mediastinal Lymph Nodes in Patients Nonsuspicious for Lung Cancer, Using Different Cryoprobe Freezing Times

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Apr 10, 2025
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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