Ultrasound-guided Cryobiopsy of Mediastinal/Hilar Lymph Nodes

April 3, 2025 updated by: University of Zurich

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Basel, Switzerland
        • Recruiting
        • Jürgen Hetzel
        • Contact:
        • Contact:
          • Jahn Kathleen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group 6 sec
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
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
Active Comparator: group 3 sec
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.).
from date of randomization to the time of the first documented results, assessed up to 100 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
from the date of randomization to the time of the first documented results, assessed up to 100 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2025

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

April 3, 2025

First Posted (Actual)

April 10, 2025

Study Record Updates

Last Update Posted (Actual)

April 10, 2025

Last Update Submitted That Met QC Criteria

April 3, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-00885

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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