The Comparison of EBUS-TBNA, TBMC Via a Tunnel, and TBFB Via a Tunnel in Diagnosing Mediastinal Lymphadenopathy.

August 24, 2024 updated by: Gang Hou, China-Japan Friendship Hospital

The Comparison of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration, Mediastinal Cryobiopsy Via a Tunnel, and Forceps Biopsy Via a Tunnel in Diagnosing Mediastinal Lymphadenopathy: a Multicenter Randomised Controlled Trial.

The goal of this prospective, multi-centre, randomised controlled clinical study is to compare the diagnostic yield and safety of the three biopsy techniques (EBUS-TBNA, EBUS-TBMC via a tunnel, and EBUS-TBFB via a tunnel) in mediastinal/hilar lymph node biopsies.

Participants will divided into EBUS-TBNA group, EBUS-TBMC via a tunnel group, and EBUS-TBFB via a tunnel group at a 1:1:1 ratio by using central, computerized random sequence, and then undertake EBUS-TBNA, EBUS-TBMC via a tunnel, or EBUS-TBFB according to the group.

Researchers will compare the diagnostic yield and incidence of adverse events of the three biopsy techniques.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

552

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 Contact Backup

  • Name: Mingming Deng, PhD
  • Phone Number: +86 18801336854
  • Email: isdeng@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:

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:

  • Age ≥ 18 years;
  • At least 1 hilar/mediastinal lesion (short axis ≥ 1 cm) requiring diagnostic bronchoscopy procedure;
  • Patients who can understand the purpose of the trial, participate voluntarily and sign an informed consent form.

Exclusion Criteria:

  • The lesion is a mediastinal cyst or abscess;
  • Combined severe cardiopulmonary diseases, coagulation disorders, poor tolerance to anaesthesia, combined psychiatric disorders or severe neurosis and other relevant contraindications to bronchoscopy;
  • EBUS assessment reveals that the lesion is rich in blood flow or adjacent to a large vessel, etc. Consider biopsy to be high risk and inappropriate for continuation of biopsy;
  • EBUS did not detect lesions in the hilum and/or mediastinum;
  • Those who, in the judgement of the investigator, have poor patient compliance and are unable to complete the study as required due to mental disorders, etc.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EBUS-transbronchial needle aspiration
Participants would undertake EBUS-transbronchial needle aspiration.
Procedure: EBUS-TBNA
A 22G biopsy needle was insert into the lesion through tracheal-bronchial wall under real-time EBUS guided by bronchoscopist. Needle punctures were performed by using the jabbing method. Once it is confirmed that the puncture needle is within the target lesion, the puncture needle is moved back and forth while suction (An empty 50 ml syringe was connected to the port at the end of the puncture needle and aspirated to 20 ml maintained for 20 seconds.) is applied. Each lymph node was operated 5 times.
Other Names:
  • Endobronchial ultrasound-guided transbronchial needle aspiration.
Experimental: EBUS-transbronchial mediastinal cryobiopsy via a tunnel
Participants would undertake EBUS-transbronchial mediastinal cryobiopsy via a tunnel.
Procedure: EBUS-TBMC via a tunnel
First a tunnel between airway wall and mediastinal and/or hilar lesion was made by a puncture dilation catheter (BroncTruTM AK-91-55, Bronchus Inc. Hangzhou, China). The 1.1mm cryoprobe (Erbe 20402-401, ERBE, Tübingen, Germany) entered the target lymph node through the tunnel under direct monitoring of EBUS, and the distance between the tip of the cryoprobe and the border of target lymph node was measured using EBUS. After confirming that the distance was >5 mm, the probe was cooled with liquid carbon dioxide for 5-9 seconds. Then retracted with the bronchoscope and the frozen biopsy tissue. Samples were retrieved by thawing in saline and then fixed in formalin. The same lymph node was operated for 3 times.
Other Names:
  • endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy via a tunnel.
Experimental: EBUS-transbronchial forceps biopsy via a tunnel
Participants would undertake EBUS-transbronchial forceps biopsy via a tunnel.
Procedure: EBUS-TBFB via a tunnel
Firstly, a tunnel to reach the lymph node is established by making use of a puncture dilation catheter, and a 1.5mm biopsy forceps is pushed into the lymph node through the working channel of the ultrasound bronchoscope. After entering the lymph node, the biopsy forceps were opened proximally to the lymph node, the biopsy forceps were advanced, and then the biopsy forceps were closed distally to the lymph node for each specimen. Each lymph node was operated 5 times.
Other Names:
  • endobronchial ultrasound-guided transbronchial forceps biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of adverse events
Time Frame: 7 days after the biopsy
Symptoms and signs
7 days after the biopsy
the adequacy of sample acquisition
Time Frame: 7 days after the biopsy
Samples resulting in a specific diagnosis or samples with the presence of lymphpcytes were considered as adequate.
7 days after the biopsy
Dignostic yield of EBUS-TBNA, EBUS-TBMC via a tunnel, and EBUS-TBFB
Time Frame: 7 days after the biopsy
The proportion of participants in whom the biopsy led to a definitive diagnosis.
7 days after the biopsy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the adequacy of sample acquisition
Time Frame: 7 days after the biopsy
Samples resulting in a specific diagnosis or samples with the presence of lymphpcytes were considered as adequate.
7 days after the biopsy

Collaborators and Investigators

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

Sponsor

China-Japan Friendship Hospital

Investigators

  • Principal Investigator: Gang Hou, MD, China-Japan Friendship Hospital

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 1, 2024

Primary Completion (Estimated)

February 18, 2026

Study Completion (Estimated)

February 18, 2026

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 24, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-NHLHCRF-LX-01-0201-06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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