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

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

Study Overview

• Status: Completed
• Conditions: Mediastinal Lymphadenopathy
• Intervention / Treatment: Procedure: EBUS-TBNA; Procedure: EBUS-TBMC via a tunnel

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • BeiJing, Beijing, China, 100029
      • China-Japan Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Procedure: EBUS-TBNA; Participants with lymphadenopathy would receive EBUS-TBNA attempts to conduct diagnoses.; Procedure: EBUS-TBMC via a tunnel; Participants with lymphadenopathy would receive EBUS-TBMC via a tunnel attempts to conduct diagnoses.
Experimental: 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.	Procedure: EBUS-TBNA; Participants with lymphadenopathy would receive EBUS-TBNA attempts to conduct diagnoses.; Procedure: EBUS-TBMC via a tunnel; Participants with lymphadenopathy would receive EBUS-TBMC via a tunnel attempts to conduct diagnoses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of adverse events	Symptoms and signs	7 days after the biopsy
Size of specimen	measurement	during the procedure
Specimen quality	questionnaire	during the procedure
Diagnostic sensitivity	The proportion of individuals who truly had the disease and tested positive.	6 months after biopsy.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2023
• Primary Completion (Actual): March 18, 2025
• Study Completion (Actual): March 18, 2025

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): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphadenopathy
• Other Study ID Numbers: 2022-NHLHCRF-LX-01-0201-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No