Study on Transbronchial Ultrasound-guided Cryobiopsy in the Diagnosis of Mediastinal Lymphadenopathy

March 11, 2024 updated by: Gang Hou, China-Japan Friendship Hospital

The Effectiveness and Safety of Transbronchial Ultrasound-guided Cryobiopsy in the Diagnosis of Mediastinal Lymphadenopathy

The goal of this clinical trial is to evaluate the diagnostic effcacy and safety of transbronchial ultrasound-guided cryobiopsy in the diagnosis of mediastinal lymphadenopathy. The main question it aims to answer are: the effectiveness and safety of transbronchial ultrasound-guided cryobiopsy in the diagnosis of mediastinal lymphadenopathy.

Participants will undergo transbronchial ultrasound-guided cryobiopsy (EBUS-TBCB) and endobronchial ultrasound-guided trans-bronchial needle aspiration (EBUS-TBNA).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

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

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients withmediastinal lymphadenopathy of unknown cause, patients with suspected sarcoidosis or lymphoma, or patients who need to undergo EBUS-TBNA for the second time
  • The selected patients should complete the routine examination of EBUS-TBNA/EBUS-TBCB before operation, such as blood routine examination, coagulation function, electrocardiogram, chest CT, etc
  • There was no contraindication of puncture and cryobiopsy
  • No age limit, no gender limit
  • Good compliance, able to cooperate with research and observation
  • 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 patient is allergic to lidocaine and midazolam
  • The site to be biopsied has a high risk of bleeding 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

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
Experimental: First EBUS-TBCB and then EBUS-TBNA group
The patients will undergo first endobronchial ultrasound-guided transbronchial ultrasound-guided cryobiopsy（EBUS-TBCB) and endobronchial ultrasound-guided transbronchial needle aspiration（EBUS-TBNA)：Routine bronchoscopy was completed, and under the guidance of EBUS, combined with CT EBUS-TBNA was used to repeatedly aspirate the tissue for 3 times (One needle is 20-50 back and forth). After the end of puncture, EBUS-TBCB was performed again, and the frozen time was about 10-15s (1.1mm cryoprobe), and the frozen time was 2-3 times to obtain at least 2 samples with a diameter of more than 5mm.
Device: EBUS-TBNA
Participants would undergo EBUS-TBNA(NA-201SX-4022, OLYMPUS MEDICAL SYSTEMS CORP, JAPAN).
Device: EBUS-TBCB
Participants would undergo EBUS-TBCB(20402-401, ERBE Elektromedizin Gmbh, Germany).
Experimental: First EBUS-TBNA and then EBUS-TBCB group
The patients will undergo first endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) and then endobronchial ultrasound-guided transbronchial ultrasound-guided cryobiopsy (EBUS-TBCB): Routine bronchoscopy was completed, combined with CT, EBUS-TBNA needle was used to determine the puncture site, and the sheath tube was used to slightly enlarge the local needle hole for EBUS-TBCB. The freezing time was about 10-15 seconds (1.1mm cryoprobe), and the freezing time was 2-3 times. To obtain at least two pieces of samples with a diameter of more than 5mm. After TBCB, EBUS-TBNA was performed in the same lymph node with 3 repeated tissue aspirations (20-50 back and back per needle).
Device: EBUS-TBNA
Participants would undergo EBUS-TBNA(NA-201SX-4022, OLYMPUS MEDICAL SYSTEMS CORP, JAPAN).
Device: EBUS-TBCB
Participants would undergo EBUS-TBCB(20402-401, ERBE Elektromedizin Gmbh, Germany).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological diagnosis rate
Time Frame: 7 days after the biopsy
The diagnosis would be confirmed according to the pathological results
7 days after the biopsy

Secondary 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
Size of specimen
Time Frame: during the procedure
measurement
during the procedure
Specimen quality
Time Frame: during the procedure
questionnaire
during the procedure

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)

April 2, 2023

Primary Completion (Estimated)

December 24, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

April 7, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-NHLHCRF-LX-01-0201-03

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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