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

NCT ID: NCT05803239

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-18
• Study Completion Date: 2025-03-18

Brief Summary

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.

Conditions

Mediastinal Lymphadenopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

EBUS-TBMC via a tunnel first group

After completing the routine bronchoscopy examination, under the EBUS guidance, combined with the results of chest CT to determine the location of puncture. Then, a disposable puncture dilation catheter (BroncTru AK-91-55; Broncus Inc., Hangzhou, China) was inserted through the working channel of the ultrasound bronchoscope and built a tunnel between the airway wall and targeted lymph node. The 1.1-mm cryoprobe (Erbe 20402-401; ERBE, Tübingen, Germany) was inserted into the target lymph node through the tunnel under direct EBUS monitoring, and the distance between the tip of the cryoprobe and the border of the 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 and freezing 3 times to obtain 3 pieces of sample. At the end of TBMC via a tunnel, EBUS-TBNA is performed in the same lymph node, and the tissue is aspirated repeatedly for 5 strokes (one stroke is 30 round trips).

Group Type: EXPERIMENTAL

EBUS-TBNA

Intervention Type: PROCEDURE

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

EBUS-TBMC via a tunnel

Intervention Type: PROCEDURE

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

EBUS-TBNA first group

Completion of routine bronchoscopy, determination of the puncture position under EBUS guidance, combined with the results of chest CT, and application of the EBUS-TBNA needle to repeatedly aspirate the tissue for 5 strokes (one stroke is 30 round trips ). At the end of the puncture, EBUS-TBMC via a tunnel was then performed with a freezing time of 5-9 seconds (1.1-mm cryoprobe), and frozen 3 times to obtain 3 pieces of samples.

Group Type: EXPERIMENTAL

EBUS-TBNA

Intervention Type: PROCEDURE

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

EBUS-TBMC via a tunnel

Intervention Type: PROCEDURE

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

Interventions

EBUS-TBNA

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

Intervention Type: PROCEDURE

EBUS-TBMC via a tunnel

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China-Japan Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gang Hou

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gang Hou, MD

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Locations

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

2022-NHLHCRF-LX-01-0201-03

Identifier Type: -

Identifier Source: org_study_id