Skip to main content
OpenTrials
Completed

NCT Number: NCT05803239

Study on Endobronchial Ultrasound-guided Transbronchial Mediastinal Cryobiopsy Via a Tunnel in the Diagnosis of Mediastinal Lymphadenopathy

The goal of this clinical trial is to clear the diagnostic yield and safety of endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (TBMC) via a tunnel. The main questions it aims to answer are:

Does EBUS-TBMC via a tunnel have a superior diagnostic yield to EBUS-transbronchial needle aspiration (TBNA)? When EBUS-TBMC via a tunnel could be performed as a first-line diagnostic tool in patients with mediastinal and/or hilar lymphadenopathy?

Researchers will compare EBUS-TBMC via a tunnel to EBUS-TBNA to see if EBUS-TBMC via a tunnel has a superior of diagnostic yield with a well-tolerance.

Participants will:

Recieve EBUS-TBMC via a tunnel and EBUS-TBNA in a predefined sequence. Recieve chest CT examination and follow-up for 7 days after procedure.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mediastinal Lymphadenopathy

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with at least one mediastinal and/or hilar lymphadenopathy (≥1cm in the short axis) in the absence of a known or suspected primary lung cancer, requiring diagnostic bronchoscopy.
  • The selected patients should complete the routine examination of EBUS-TBNA/EBUS-TBMC via a tunnel before operation, such as blood routine examination, coagulation function, electrocardiogram, chest CT, etc.
  • There was no contraindication of puncture and cryobiopsy.
  • Fully informed of the purpose and method of the study, agreed to participate in the study, and signed the informed consent form.

Exclusion criteria

  • The lesion is a mediastinal cyst or abscess.
  • The patient is allergic to lidocaine and midazolam.
  • The site to be biopsied has a high risk of bleeding detected by Doppler and/or contrast CT such as bronchial artery penetration or suspected lung metastasis of renal cancer.
  • Unstable angina pectoris, congestive heart failure, severe bronchial asthma
  • The patient did not agree to participate in this study
  • Participation in other studies within three months without withdrawal or termination will affect the observation of this study
  • The researcher believes that there is any person who is not suitable for the selection

Treatment and study plan

EBUS-TBNA

Procedure

Participants with lymphadenopathy would receive EBUS-TBNA attempts to conduct diagnoses.

EBUS-TBMC via a tunnel

Procedure

Participants with lymphadenopathy would receive EBUS-TBMC via a tunnel attempts to conduct diagnoses.

Primary outcomes

  1. Diagnostic yield

    Time frame: 6 months after the biopsy

    The proportion of all individuals undergoing the diagnostic procedure under evaluation in whom a specific diagnosis was established. All the final diagnosis in this trial were established by the treating clinician and verified by an independent diagnosis verification panel which included three pulmonary and critical care medicine physicians, one radiologist, and one pathologist.

Secondary outcomes

  1. Diagnostic sensitivity

    Time frame: 6 months after biopsy.

    The proportion of individuals who truly had the disease and tested positive.

  2. Incidence rate of adverse events

    Time frame: 7 days after the biopsy

    Symptoms and signs

  3. Size of specimen

    Time frame: during the procedure

    measurement

  4. Specimen quality

    Time frame: during the procedure

    questionnaire

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Official study title

The Diagnostic Yield and Safety of Endobronchial Ultrasound-guided Mediastinal Cryobiopsy Via a Tunnel in Mediastinal Lymphadenopathy

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 7, 2023
Registry last updated
Jul 20, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.