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

NCT05803239 | Completed

• 1 other identifier: 2022-NHLHCRF-LX-01-0201-03
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield

  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.

  6 months after the biopsy

Secondary Outcomes (4)

• Diagnostic sensitivity

  6 months after biopsy.

• Incidence rate of adverse events

  7 days after the biopsy

• Size of specimen

  during the procedure

• Specimen quality

  during the procedure

Study Arms (2)

EBUS-TBMC via a tunnel first group

EXPERIMENTAL

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).

Procedure: EBUS-TBNA; Procedure: EBUS-TBMC via a tunnel

EBUS-TBNA first group

EXPERIMENTAL

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.

Procedure: EBUS-TBNA; Procedure: EBUS-TBMC via a tunnel

Interventions

EBUS-TBNA PROCEDURE

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

EBUS-TBMC via a tunnel first group; EBUS-TBNA first group

EBUS-TBMC via a tunnel PROCEDURE

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

EBUS-TBMC via a tunnel first group; EBUS-TBNA first group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

Study Officials

• Gang Hou, MD

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 7, 2023
• Study Start: February 18, 2023
• Primary Completion: March 18, 2025
• Study Completion: March 18, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)